Effects of intraoperative pyloric stretch procedure on outcomes after esophagectomy

Effects of intraoperative pyloric stretch procedure on outcomes after esophagectomy Summary Various methods have been described to aid pyloric drainage in patients undergoing esophagectomy with gastric reconstruction. These techniques are intended to prevent delayed gastric empting following esophagectomy that can be associated with early morbidity and long-term functional complaints. The current study aims to review the safety and efficacy of a pyloric stretch procedure performed at the time of esophagectomy. To achieve this, a retrospective review of 100 consecutive patients undergoing esophagectomy during the period 2011–2016 was performed. Until May 2013, no patients received intraoperative pyloric intervention. After May 2013, all patients (N = 50) underwent intraoperative pyloric stretch procedure that involved bidirectional mechanical dilatation of the pylorus. Postoperative outcomes including result of routine oral contrast swallow and early morbidity were evaluated. Intraoperative pyloric stretching was performed safely and without local complications in all patients. Delayed gastric emptying was observed significantly less frequently in patients who received intraoperative pyloric stretching (48% vs. 22%, P = 0.006). No significant differences were observed in postoperative outcomes. When considering all patients as a single cohort, the presence of delayed gastric emptying was associated with significantly higher rates of postoperative pneumonia (71% vs. 45%, P = 0.010), cardiac complications (57% vs. 25%, P = 0.001) as well as longer hospital say (12 vs. 15 days, P < 0.001) and delay to free oral fluid intake (7 vs. 9 days, < 0.001). Binary logistic regression identified age and postoperative delayed gastric emptying as independent risk factors for postoperative pneumonia. In conclusion, this study has demonstrated the safety and efficacy an intraoperative pyloric stretch procedure for the prevention of delayed gastric emptying following esophagectomy. INTRODUCTION Esophagectomy with gastric reconstruction may often be associated with pyloric dysfunction leading to delayed gastric emptying (DGE). The mechanisms underlying this effect are poorly understood but are likely to be a consequence the combined denervation, tubularization, and reorientation of the stomach in an extra-anatomical position. These factors may contribute to pyloric spasm and gastric hypomotility. The occurrence and extent of pyloric dysfunction after esophagectomy varies between individual patients and is difficult to predict. Distension of the gastric conduit in the early postoperative period may lead to pressurization of the newly formed anastomosis and aspiration of intestinal contents into the lungs. For those patients who achieve long-term survival after esophagectomy, gastric dysfunction can also have a detrimental effect on quality of life with symptoms of early satiety and reflux. The nature and timing of intervention to aid pyloric drainage in the setting of esophagectomy is often a matter of preference for individual surgeons. While many would advocate a pre-emptive approach to this clinical problem at the time of esophagectomy others would support a more conservative strategy whereby patients are managed according to symptoms, clinical signs, and the findings of staged investigations. Among the numerous techniques described to promote pyloric drainage, the most common include intraoperative pyloroplasty and pyloromyotomy. The use of intraoperative and more often postoperative pyloric balloon dilatation and botulinum toxin injection is also widely described. Despite numerous reports of the use of these techniques, there is limited evidence to support their adoption in regard to improving postoperative DGE, anastomotic leak rate, and pulmonary complications.1 Furthermore, there is some evidence to suggest that intraoperative pyloric procedures may have detrimental effect relating to the higher occurrence rates of postoperative reflux and dumping syndrome.1,2 There have been several reports in the literature of the use of an intraoperative pyloric stretch procedure to aid postoperative gastric emptying.3,4 Potential benefits of this technique include the ability to apply direct mechanical dilation of the pylorus avoiding the need for incision of surrounding seromuscular tissues. It is hypothesized that intraoperative pyloric stretching will diminish the incidence of postoperative DGE and morbidity with which it is associated. The aim of this study therefore is determine the effect of a pyloric stretch procedure, performed at the time of esophagectomy, on postoperative outcomes including DGE, requirement for postoperative pyloric dilation and early morbidity. METHODOLOGY A retrospective review of 100 consecutive patients undergoing either two- or three-stage esophagectomy for esophageal cancer with radical lymphadenectomy and gastric pull-up between June 2011 and December 2016 under the care of a single surgeon (GH) was performed at St Mary's hospital. The surgical approach for tumors of the gastroesophageal junction and lower esophagus was two-stage (Ivor Lewis) esophagectomy with abdominal and thoracic (infracarinal) lymphadenectomy. For tumors of the lower- and mid-esophagus lymph node dissection was extended to the upper mediastinum and area surrounding the recurrent laryngeal nerves. Cervical lymphadenectomy via a three-staged surgical approach was performed only for tumors of the upper esophagus. Esophageal reconstruction in all cases was via single layer handsewn anastomosis performed either within the thoracic cavity or left cervical region in the case or two- and three-stage esophagectomy, respectively. A standard gastric conduit width between 4 and 5 cm was used in all cases. Introspective pyloric stretch procedure Prior to May 2013 patients undergoing esophagec-tomy were not subject to any form of intraoperative intervention to aid postoperative pyloric dilation. After May 2013 all patients underwent intraoperative pyloric stretch procedure as described by Manjari et al.4 In this cohort, this procedure was performed by passing a Rampleys sponge holding forceps through a gastrostomy that was created proximal to the intended gastric resection margin. The tips of this instrument were passed in to the pylorus and opened under sustained force in a cranial-caudal plane of direction for two minutes. This process was subsequently repeated within a perpendicular (anteroposterior) plane to ensure the intended circumferential dilation of the pylorus. Postoperative management including protocol for assessment of anastomotic integrity and pyloric drainage Postoperatively patients were initially managed within an intensive care unit. Patients were subsequently transferred to a high dependency unit and finally to a general surgical ward. All patients received analgesia via a thoracic epidural. In addition to thoracic and abdominal drains, nasogastric tube was used to decompress the gastric conduit. From postoperative day one, patients received either enteral nutrient via feeding jejunostomy placed at the time of surgery or total parenteral nutrition. An oral meglumine diatrizoate and diatrizoate sodium (Gastrografin; Bracco Diagnostics Inc.) contrast study was performed on either postoperative day four or five to assess for both anastomotic continuity and DGE. Where patients were not medically able to undergo oral contrast study at this time, for example due to delayed/reintubation, this investigation was deferred to the soonest appropriate future date. In patients with no evidence either anastomotic leak or DGE, oral intake was cautiously resumed initially with sips of clear fluid. In those patients found to have DGE, defined as excessively slow or absent flow of contrast into the first part of the duodenum after 15 minutes of consuming oral contrast, the nasogastric tube remained in situ on free drainage and oral intake continued to be withheld. As no standard definition exists for DGE after esophagectomy,1 criteria were determined in accordance with local practice but were informed by previous studies.5 These patients underwent radiologically guided pyloric balloon dilatation at the soonest available opportunity. A repeat oral contrast study was performed typically within 24 hours of balloon dilation to reassess gastric emptying. Oral intake was only reintroduced after successful demonstration of prompt (majority of contrast passing into the first part of the duodenum within <15 minutes) gastric emptying in the absence of anastomotic leak. In all patients progression to free oral fluids (including, liquids, clear soup, jelly, and ice cream) occurred only once patients were observed to have tolerated sips of clear fluid, typically by postoperative day 6 to 7. In patients with deviation from the predicted recovery course prompt investigation using computer tomography with intravenous and/or oral contrast was performed. After hospital discharge patients continued to receive supplementary home jejunal feeding until satisfactory oral intake had been achieved. Patients were followed up every three months for the first two years after resection and subsequently every six months until five years. In the absence of concerning clinical signs patients underwent yearly radiological surveillance with computer tomography. Full definitions of all postoperative complications are provided in an on-line supplementary file. The diagnosis of postoperative pneumonia was based on clinical (fever > 38°C, increased respiratory secretions or leukocytosis/leukopenia) and radiological (not atelectasis) evidence of chest infection, for which antibiotic therapy was started. Cardiac complications were considered as any acute ischemic event or new arrhythmias (both determined by clinical examination and a combination of electrocardiography, echocardiography, or serum troponins) requiring therapeutic intervention. Statistical analysis Statistical analysis was performed using SPSS (Version 24.0, IBM Corp., Armonk, USA). Continuous variables are presented as mean ± standard deviation unless otherwise stated. Chi-squared or Fishers exact tests were used to compare categorical data; Students t-test (parametric data) or the Mann–Whitney U test (nonparametric data) were used to compare continuous data. Binary logistic regression was used to determine variables predicative of postoperative pneumonia. Two-sided P values ≤ 0.05 were considered statistically significant. RESULTS Details of patient demographics and postoperative outcomes for each study cohort are presented in Table 1. With the exception of current/previous smoking habit patients groups were well match in terms of other baseline characteristics. Intraoperative pyloric stretch procedure was simple to perform and was not associated with adverse intraoperative outcomes. The total length of additional operative time required to perform this procedure was approximately 6 minutes per case. Table 1 Patient demographics and outcomes No intra-op dilation Intra-op dilation n = 50 n = 50 P value Age 62.7 ± 11.6 63.4 ± 10.5 0.755 Gender (M:F) 40/10 44/6 0.275 BMI 27.8 ± 4.7 27.9 ± 5.5 0.889 Current or exsmoker 29 38 0.024 Neoadjuvant therapy Chemotherapy 38 33 0.141 Chemoradiotherapy 1 6 ASA (2/3) 36/14 36/14 – Charlson comorbidity score 4.4 ± 1.5 [2–8] 4.1 ± 1.2 [2–8] 0.245 Surgical approach Two-stage oesophagectomy 36 40 0.349 Three-stage esophagectomy* 14 10 Histology Adenocarcinoma 36 41 0.492 Squamous cell carcinoma 8 5 Other 6 4 T0-is/T1/T2/T3/T4 1/12/8/25/4 5/13/4/25/3 0.382 N0/N1/N2/N3 19/18/7/6 24/12/10/4 0.438 Lymph nodes excised 67 (58–76) 63 (52–75) 0.142 Length of surgery including anesthesia (hours) 10.7 ± 1.4 10.6 ± 1.5 0.831 Length OLV (hours) 3.5 ± 0.8 3.2 ± 0.8 0.049 Urine output (mL) 1145 ± 623 786 ± 414 0.009 Intraoperative fluid (mL) 6149 ± 2043 5320 ± 2124 0.074 Length of ICU/HDU stay (days) 5 (3–7) 5 (2–6) 0.313 Length of hospital stay (day) 14 (11–22) 12 (10–15) 0.160 Post-op oral free fluids (day) 8 (7–9) 7 (6–9) 0.270 Delayed gastric emptying 24 (48) 11 (22) 0.006 In hospital mortality 0 (0) 0 (0) 0.495* Anastomotic leak 2 (4) 0 (0) 0.495* Unplanned return to theatre 1 (2) 1 (2) 1.000* Pneumonia 26 (52) 28 (56) 0.668 ARDS 0 (0) 1 (2) 1.000v Cardiac complication 21 (42) 15 (30) 0.211 Chyle leak 5 (10) 6 (12) 1.000* Pleural effusion 11 (22) 4 (8) 0.091* RLN-palsy/praxia 3 (6) 3 (6) 1.000* Haemorrhage 2 (2) 0 (0) 0.495* Wound infection 5 (10) 4 (8) 1.000* CVA 1 (2) 0 (0) 1.000* Acute renal failure 1 (2) 0 (0) 1.000* DVT/PE 2/0 (4/0) 1/1 (2/2) 1.000* No intra-op dilation Intra-op dilation n = 50 n = 50 P value Age 62.7 ± 11.6 63.4 ± 10.5 0.755 Gender (M:F) 40/10 44/6 0.275 BMI 27.8 ± 4.7 27.9 ± 5.5 0.889 Current or exsmoker 29 38 0.024 Neoadjuvant therapy Chemotherapy 38 33 0.141 Chemoradiotherapy 1 6 ASA (2/3) 36/14 36/14 – Charlson comorbidity score 4.4 ± 1.5 [2–8] 4.1 ± 1.2 [2–8] 0.245 Surgical approach Two-stage oesophagectomy 36 40 0.349 Three-stage esophagectomy* 14 10 Histology Adenocarcinoma 36 41 0.492 Squamous cell carcinoma 8 5 Other 6 4 T0-is/T1/T2/T3/T4 1/12/8/25/4 5/13/4/25/3 0.382 N0/N1/N2/N3 19/18/7/6 24/12/10/4 0.438 Lymph nodes excised 67 (58–76) 63 (52–75) 0.142 Length of surgery including anesthesia (hours) 10.7 ± 1.4 10.6 ± 1.5 0.831 Length OLV (hours) 3.5 ± 0.8 3.2 ± 0.8 0.049 Urine output (mL) 1145 ± 623 786 ± 414 0.009 Intraoperative fluid (mL) 6149 ± 2043 5320 ± 2124 0.074 Length of ICU/HDU stay (days) 5 (3–7) 5 (2–6) 0.313 Length of hospital stay (day) 14 (11–22) 12 (10–15) 0.160 Post-op oral free fluids (day) 8 (7–9) 7 (6–9) 0.270 Delayed gastric emptying 24 (48) 11 (22) 0.006 In hospital mortality 0 (0) 0 (0) 0.495* Anastomotic leak 2 (4) 0 (0) 0.495* Unplanned return to theatre 1 (2) 1 (2) 1.000* Pneumonia 26 (52) 28 (56) 0.668 ARDS 0 (0) 1 (2) 1.000v Cardiac complication 21 (42) 15 (30) 0.211 Chyle leak 5 (10) 6 (12) 1.000* Pleural effusion 11 (22) 4 (8) 0.091* RLN-palsy/praxia 3 (6) 3 (6) 1.000* Haemorrhage 2 (2) 0 (0) 0.495* Wound infection 5 (10) 4 (8) 1.000* CVA 1 (2) 0 (0) 1.000* Acute renal failure 1 (2) 0 (0) 1.000* DVT/PE 2/0 (4/0) 1/1 (2/2) 1.000* Values in parentheses are percentages. *A single patient from each group underwent thoracoscopic mobilization of the thoracic esophagus, the abdominal stage was however performed using the standard open approach. ARDS, adult respiratory distress syndrome; ASA, American Society of Anesthesiologists grade; BMI, body mass index; CVA, cerebrovascular accident; DVT, deep vein thrombosis; HDU, high dependency care unit; ICU, intensive care unit; MI, minimally invasive; OLV, one-lung ventilation; RLN, recurrent laryngeal nerve; PE, pulmonary embolism. View Large Table 1 Patient demographics and outcomes No intra-op dilation Intra-op dilation n = 50 n = 50 P value Age 62.7 ± 11.6 63.4 ± 10.5 0.755 Gender (M:F) 40/10 44/6 0.275 BMI 27.8 ± 4.7 27.9 ± 5.5 0.889 Current or exsmoker 29 38 0.024 Neoadjuvant therapy Chemotherapy 38 33 0.141 Chemoradiotherapy 1 6 ASA (2/3) 36/14 36/14 – Charlson comorbidity score 4.4 ± 1.5 [2–8] 4.1 ± 1.2 [2–8] 0.245 Surgical approach Two-stage oesophagectomy 36 40 0.349 Three-stage esophagectomy* 14 10 Histology Adenocarcinoma 36 41 0.492 Squamous cell carcinoma 8 5 Other 6 4 T0-is/T1/T2/T3/T4 1/12/8/25/4 5/13/4/25/3 0.382 N0/N1/N2/N3 19/18/7/6 24/12/10/4 0.438 Lymph nodes excised 67 (58–76) 63 (52–75) 0.142 Length of surgery including anesthesia (hours) 10.7 ± 1.4 10.6 ± 1.5 0.831 Length OLV (hours) 3.5 ± 0.8 3.2 ± 0.8 0.049 Urine output (mL) 1145 ± 623 786 ± 414 0.009 Intraoperative fluid (mL) 6149 ± 2043 5320 ± 2124 0.074 Length of ICU/HDU stay (days) 5 (3–7) 5 (2–6) 0.313 Length of hospital stay (day) 14 (11–22) 12 (10–15) 0.160 Post-op oral free fluids (day) 8 (7–9) 7 (6–9) 0.270 Delayed gastric emptying 24 (48) 11 (22) 0.006 In hospital mortality 0 (0) 0 (0) 0.495* Anastomotic leak 2 (4) 0 (0) 0.495* Unplanned return to theatre 1 (2) 1 (2) 1.000* Pneumonia 26 (52) 28 (56) 0.668 ARDS 0 (0) 1 (2) 1.000v Cardiac complication 21 (42) 15 (30) 0.211 Chyle leak 5 (10) 6 (12) 1.000* Pleural effusion 11 (22) 4 (8) 0.091* RLN-palsy/praxia 3 (6) 3 (6) 1.000* Haemorrhage 2 (2) 0 (0) 0.495* Wound infection 5 (10) 4 (8) 1.000* CVA 1 (2) 0 (0) 1.000* Acute renal failure 1 (2) 0 (0) 1.000* DVT/PE 2/0 (4/0) 1/1 (2/2) 1.000* No intra-op dilation Intra-op dilation n = 50 n = 50 P value Age 62.7 ± 11.6 63.4 ± 10.5 0.755 Gender (M:F) 40/10 44/6 0.275 BMI 27.8 ± 4.7 27.9 ± 5.5 0.889 Current or exsmoker 29 38 0.024 Neoadjuvant therapy Chemotherapy 38 33 0.141 Chemoradiotherapy 1 6 ASA (2/3) 36/14 36/14 – Charlson comorbidity score 4.4 ± 1.5 [2–8] 4.1 ± 1.2 [2–8] 0.245 Surgical approach Two-stage oesophagectomy 36 40 0.349 Three-stage esophagectomy* 14 10 Histology Adenocarcinoma 36 41 0.492 Squamous cell carcinoma 8 5 Other 6 4 T0-is/T1/T2/T3/T4 1/12/8/25/4 5/13/4/25/3 0.382 N0/N1/N2/N3 19/18/7/6 24/12/10/4 0.438 Lymph nodes excised 67 (58–76) 63 (52–75) 0.142 Length of surgery including anesthesia (hours) 10.7 ± 1.4 10.6 ± 1.5 0.831 Length OLV (hours) 3.5 ± 0.8 3.2 ± 0.8 0.049 Urine output (mL) 1145 ± 623 786 ± 414 0.009 Intraoperative fluid (mL) 6149 ± 2043 5320 ± 2124 0.074 Length of ICU/HDU stay (days) 5 (3–7) 5 (2–6) 0.313 Length of hospital stay (day) 14 (11–22) 12 (10–15) 0.160 Post-op oral free fluids (day) 8 (7–9) 7 (6–9) 0.270 Delayed gastric emptying 24 (48) 11 (22) 0.006 In hospital mortality 0 (0) 0 (0) 0.495* Anastomotic leak 2 (4) 0 (0) 0.495* Unplanned return to theatre 1 (2) 1 (2) 1.000* Pneumonia 26 (52) 28 (56) 0.668 ARDS 0 (0) 1 (2) 1.000v Cardiac complication 21 (42) 15 (30) 0.211 Chyle leak 5 (10) 6 (12) 1.000* Pleural effusion 11 (22) 4 (8) 0.091* RLN-palsy/praxia 3 (6) 3 (6) 1.000* Haemorrhage 2 (2) 0 (0) 0.495* Wound infection 5 (10) 4 (8) 1.000* CVA 1 (2) 0 (0) 1.000* Acute renal failure 1 (2) 0 (0) 1.000* DVT/PE 2/0 (4/0) 1/1 (2/2) 1.000* Values in parentheses are percentages. *A single patient from each group underwent thoracoscopic mobilization of the thoracic esophagus, the abdominal stage was however performed using the standard open approach. ARDS, adult respiratory distress syndrome; ASA, American Society of Anesthesiologists grade; BMI, body mass index; CVA, cerebrovascular accident; DVT, deep vein thrombosis; HDU, high dependency care unit; ICU, intensive care unit; MI, minimally invasive; OLV, one-lung ventilation; RLN, recurrent laryngeal nerve; PE, pulmonary embolism. View Large Patients in the initial group who did not undergo intraoperative pyloric stretch procedure tended to have a greater volume of intraoperative fluid (P = 0.074) and longer duration of one-lung ventilation (P = 0.049). Postoperative ICU/HDU and hospital stay were equivalent between the two study groups as were postoperative complications. There was no in hospital mortality. Two patients died following hospital discharge but within 90 days of surgery: one death was due to cardiac arrest following myocardial infarction which occurred three weeks following surgery (confirmed on postmortem examination) and the second death occurred seven weeks following surgery as a result of hemophagocytic lymphohistiocytosis, a rare hematological disorder (confirmed on bone marrow biopsy). DGE was observed in 24 (48%) patients who underwent surgery prior to in introduction of intraoperative pyloric stretching and in 11 (22%) patients who received this intervention (P = 0.006). All patients who had evidence of DGE underwent radiologically guided pyloric balloon dilatation. With the exception of one patient who required two postoperative dilatations, single postoperative pyloric dilation resulted in resolution of DGE as assessed by repeat contrast swallow. The occurrence of postoperative pyloric DGE (n = 35), regardless of whether intraoperative dilatation was performed, was associated with longer postoperative ICU/HDU (P = 0.005) and hospital (P < 0.001) stay as well as a significantly longer interval to postoperative oral fluid intake (P < 0.001) (Table 2). Patients with DGE were more likely to have postoperative pneumonia (71% vs. 45%, P = 0.010) and cardiac complications (57% vs. 25%, P = 0.001). Binary logistic regression of revealed age and postoperative DGE were independent risk factors for postoperative pneumonia (Table 3). Table 2 Patient demographics and outcomes based on the presence or absence of postoperative delayed gastric emptying No delayed gastric Delayed gastric emptying n = 65 emptying n = 35 P Age 63.0 ± 10.5 63.0 ± 11.5 0.968 Gender (M:F) 53:12 31:4 0.408* BMI 27.8 ± 4.7 27.9 ± 5.6 0.952 Current or exsmoker 44 23 0.674 Neoadjuvant therapy Chemotherapy 45 26 0.492 Chemoradiotherapy 6 1 ASA (2/3) 50:15 22:13 0.135 Charlson co-morbidity score 4.2 ± 1.3 [2–8] 4.3 ± 1.5 [2–8] 0.627 Surgical approach Two-stage esophagectomy 48 28 0.492 Three-stage esophagectomy1 17 7 Histology 48 29 0.559 Adenocarcinoma 10 3 Squamous cell carcinoma 7 3 Other T0-is/T1/T2/T3/T4 3/16/6/35/5 3/9/6/15/2 0.650 N0/N1/N2/N3 27/18/12/8 16/12/5/2 0.649 Lymph nodes excised 64 (55–75) 66 (56–76) 0.848 Length of surgery (hours) 10.7 ± 1.4 10.6 ± 1.5 0.025 Length OLV (hours) 3.5 ± 0.8 3.2 ± 0.8 0.032 Urine output (mL) 991 ± 545 1039 ± 636 0.729 Intraoperative fluid (mL) 5691 ± 2233 5934 ± 1924 0.611 Length of ICU/HDU stay (days) 4 (2–6) 6 (3–8) 0.005 Length of hospital stay (day) 12 (10–14) 15 (13–28) <0.001 Post-op oral fluid intake (day) 7 (6–8) 9 (8–11) <0.001 In hospital mortality 0 (0) 0 (0) 1.000* Anastomotic leak 0 (0) 2 (6) 0.120* Unplanned return to theatre 2 (3) 0 (0) 0.540* Pneumonia 29 (45) 25 (71) 0.010 ARDS 1 (2) 0 (0) 1.000* Cardiac complication 16 (25) 20 (57) 0.001 Chyle leak 9 (14) 2 (6) 0.320* Pleural effusion 8 (12) 7 (20) 0.304 RLN-palsy/praxia 4 (6) 2 (6) 1.000* Haemorrhage 0 (0) 2 (6) 0.120* Wound infection 5 (8) 4 (11) 0.716* CVA 1 (2) 0 (0) 1.000* Acute renal failure 0 (0) 1 (3) 0.350* DVT/PE 1/1 (2/2) 2/0 (6/0) >0.200* No delayed gastric Delayed gastric emptying n = 65 emptying n = 35 P Age 63.0 ± 10.5 63.0 ± 11.5 0.968 Gender (M:F) 53:12 31:4 0.408* BMI 27.8 ± 4.7 27.9 ± 5.6 0.952 Current or exsmoker 44 23 0.674 Neoadjuvant therapy Chemotherapy 45 26 0.492 Chemoradiotherapy 6 1 ASA (2/3) 50:15 22:13 0.135 Charlson co-morbidity score 4.2 ± 1.3 [2–8] 4.3 ± 1.5 [2–8] 0.627 Surgical approach Two-stage esophagectomy 48 28 0.492 Three-stage esophagectomy1 17 7 Histology 48 29 0.559 Adenocarcinoma 10 3 Squamous cell carcinoma 7 3 Other T0-is/T1/T2/T3/T4 3/16/6/35/5 3/9/6/15/2 0.650 N0/N1/N2/N3 27/18/12/8 16/12/5/2 0.649 Lymph nodes excised 64 (55–75) 66 (56–76) 0.848 Length of surgery (hours) 10.7 ± 1.4 10.6 ± 1.5 0.025 Length OLV (hours) 3.5 ± 0.8 3.2 ± 0.8 0.032 Urine output (mL) 991 ± 545 1039 ± 636 0.729 Intraoperative fluid (mL) 5691 ± 2233 5934 ± 1924 0.611 Length of ICU/HDU stay (days) 4 (2–6) 6 (3–8) 0.005 Length of hospital stay (day) 12 (10–14) 15 (13–28) <0.001 Post-op oral fluid intake (day) 7 (6–8) 9 (8–11) <0.001 In hospital mortality 0 (0) 0 (0) 1.000* Anastomotic leak 0 (0) 2 (6) 0.120* Unplanned return to theatre 2 (3) 0 (0) 0.540* Pneumonia 29 (45) 25 (71) 0.010 ARDS 1 (2) 0 (0) 1.000* Cardiac complication 16 (25) 20 (57) 0.001 Chyle leak 9 (14) 2 (6) 0.320* Pleural effusion 8 (12) 7 (20) 0.304 RLN-palsy/praxia 4 (6) 2 (6) 1.000* Haemorrhage 0 (0) 2 (6) 0.120* Wound infection 5 (8) 4 (11) 0.716* CVA 1 (2) 0 (0) 1.000* Acute renal failure 0 (0) 1 (3) 0.350* DVT/PE 1/1 (2/2) 2/0 (6/0) >0.200* Values in parentheses are percentages. *A single patient from each group underwent thoracoscopic mobilization of the thoracic esophagus, the abdominal stage was however performed using the standard open approach. ASA, American Society of Anesthesiologists grade; ARDS, adult respiratory distress syndrome; BMI, body mass index; CVA, cerebrovascular accident; DVT, deep vein thrombosis; ICU, intensive care unit; HDU, high dependency care unit; MI, minimally invasive; OLV, one-lung ventilation; PE, pulmonary embolism; RLN, recurrent laryngeal nerve. View Large Table 2 Patient demographics and outcomes based on the presence or absence of postoperative delayed gastric emptying No delayed gastric Delayed gastric emptying n = 65 emptying n = 35 P Age 63.0 ± 10.5 63.0 ± 11.5 0.968 Gender (M:F) 53:12 31:4 0.408* BMI 27.8 ± 4.7 27.9 ± 5.6 0.952 Current or exsmoker 44 23 0.674 Neoadjuvant therapy Chemotherapy 45 26 0.492 Chemoradiotherapy 6 1 ASA (2/3) 50:15 22:13 0.135 Charlson co-morbidity score 4.2 ± 1.3 [2–8] 4.3 ± 1.5 [2–8] 0.627 Surgical approach Two-stage esophagectomy 48 28 0.492 Three-stage esophagectomy1 17 7 Histology 48 29 0.559 Adenocarcinoma 10 3 Squamous cell carcinoma 7 3 Other T0-is/T1/T2/T3/T4 3/16/6/35/5 3/9/6/15/2 0.650 N0/N1/N2/N3 27/18/12/8 16/12/5/2 0.649 Lymph nodes excised 64 (55–75) 66 (56–76) 0.848 Length of surgery (hours) 10.7 ± 1.4 10.6 ± 1.5 0.025 Length OLV (hours) 3.5 ± 0.8 3.2 ± 0.8 0.032 Urine output (mL) 991 ± 545 1039 ± 636 0.729 Intraoperative fluid (mL) 5691 ± 2233 5934 ± 1924 0.611 Length of ICU/HDU stay (days) 4 (2–6) 6 (3–8) 0.005 Length of hospital stay (day) 12 (10–14) 15 (13–28) <0.001 Post-op oral fluid intake (day) 7 (6–8) 9 (8–11) <0.001 In hospital mortality 0 (0) 0 (0) 1.000* Anastomotic leak 0 (0) 2 (6) 0.120* Unplanned return to theatre 2 (3) 0 (0) 0.540* Pneumonia 29 (45) 25 (71) 0.010 ARDS 1 (2) 0 (0) 1.000* Cardiac complication 16 (25) 20 (57) 0.001 Chyle leak 9 (14) 2 (6) 0.320* Pleural effusion 8 (12) 7 (20) 0.304 RLN-palsy/praxia 4 (6) 2 (6) 1.000* Haemorrhage 0 (0) 2 (6) 0.120* Wound infection 5 (8) 4 (11) 0.716* CVA 1 (2) 0 (0) 1.000* Acute renal failure 0 (0) 1 (3) 0.350* DVT/PE 1/1 (2/2) 2/0 (6/0) >0.200* No delayed gastric Delayed gastric emptying n = 65 emptying n = 35 P Age 63.0 ± 10.5 63.0 ± 11.5 0.968 Gender (M:F) 53:12 31:4 0.408* BMI 27.8 ± 4.7 27.9 ± 5.6 0.952 Current or exsmoker 44 23 0.674 Neoadjuvant therapy Chemotherapy 45 26 0.492 Chemoradiotherapy 6 1 ASA (2/3) 50:15 22:13 0.135 Charlson co-morbidity score 4.2 ± 1.3 [2–8] 4.3 ± 1.5 [2–8] 0.627 Surgical approach Two-stage esophagectomy 48 28 0.492 Three-stage esophagectomy1 17 7 Histology 48 29 0.559 Adenocarcinoma 10 3 Squamous cell carcinoma 7 3 Other T0-is/T1/T2/T3/T4 3/16/6/35/5 3/9/6/15/2 0.650 N0/N1/N2/N3 27/18/12/8 16/12/5/2 0.649 Lymph nodes excised 64 (55–75) 66 (56–76) 0.848 Length of surgery (hours) 10.7 ± 1.4 10.6 ± 1.5 0.025 Length OLV (hours) 3.5 ± 0.8 3.2 ± 0.8 0.032 Urine output (mL) 991 ± 545 1039 ± 636 0.729 Intraoperative fluid (mL) 5691 ± 2233 5934 ± 1924 0.611 Length of ICU/HDU stay (days) 4 (2–6) 6 (3–8) 0.005 Length of hospital stay (day) 12 (10–14) 15 (13–28) <0.001 Post-op oral fluid intake (day) 7 (6–8) 9 (8–11) <0.001 In hospital mortality 0 (0) 0 (0) 1.000* Anastomotic leak 0 (0) 2 (6) 0.120* Unplanned return to theatre 2 (3) 0 (0) 0.540* Pneumonia 29 (45) 25 (71) 0.010 ARDS 1 (2) 0 (0) 1.000* Cardiac complication 16 (25) 20 (57) 0.001 Chyle leak 9 (14) 2 (6) 0.320* Pleural effusion 8 (12) 7 (20) 0.304 RLN-palsy/praxia 4 (6) 2 (6) 1.000* Haemorrhage 0 (0) 2 (6) 0.120* Wound infection 5 (8) 4 (11) 0.716* CVA 1 (2) 0 (0) 1.000* Acute renal failure 0 (0) 1 (3) 0.350* DVT/PE 1/1 (2/2) 2/0 (6/0) >0.200* Values in parentheses are percentages. *A single patient from each group underwent thoracoscopic mobilization of the thoracic esophagus, the abdominal stage was however performed using the standard open approach. ASA, American Society of Anesthesiologists grade; ARDS, adult respiratory distress syndrome; BMI, body mass index; CVA, cerebrovascular accident; DVT, deep vein thrombosis; ICU, intensive care unit; HDU, high dependency care unit; MI, minimally invasive; OLV, one-lung ventilation; PE, pulmonary embolism; RLN, recurrent laryngeal nerve. View Large Table 3 Multivariate analysis of factors predictive of postoperative pneumonia Odds ratio 95% confidence interval P Intra-op pyloric stretch 1.917 0.710–5.177 0.199 Age 0.902 0.823–0.988 0.027 Gender 0.982 0.279–3.452 0.977 Smoking history 1.809 0.686–4.765 0.231 Charlson comorbidity index 1.995 0.973–4.091 0.060 ASA grade 1.685 0.610–4.654 0.314 Operative procedure* 1.182 0.401–3.481 0.762 Post-op DGE 3.820 1.417–4.091 0.008 Odds ratio 95% confidence interval P Intra-op pyloric stretch 1.917 0.710–5.177 0.199 Age 0.902 0.823–0.988 0.027 Gender 0.982 0.279–3.452 0.977 Smoking history 1.809 0.686–4.765 0.231 Charlson comorbidity index 1.995 0.973–4.091 0.060 ASA grade 1.685 0.610–4.654 0.314 Operative procedure* 1.182 0.401–3.481 0.762 Post-op DGE 3.820 1.417–4.091 0.008 *Defined as either two- or three-stage esophagectomy requiring either thoracic or cervical anastomosis respectively. ASA, American Society of Anesthesiologists grade; DGE, delayed gastric emptying. View Large Table 3 Multivariate analysis of factors predictive of postoperative pneumonia Odds ratio 95% confidence interval P Intra-op pyloric stretch 1.917 0.710–5.177 0.199 Age 0.902 0.823–0.988 0.027 Gender 0.982 0.279–3.452 0.977 Smoking history 1.809 0.686–4.765 0.231 Charlson comorbidity index 1.995 0.973–4.091 0.060 ASA grade 1.685 0.610–4.654 0.314 Operative procedure* 1.182 0.401–3.481 0.762 Post-op DGE 3.820 1.417–4.091 0.008 Odds ratio 95% confidence interval P Intra-op pyloric stretch 1.917 0.710–5.177 0.199 Age 0.902 0.823–0.988 0.027 Gender 0.982 0.279–3.452 0.977 Smoking history 1.809 0.686–4.765 0.231 Charlson comorbidity index 1.995 0.973–4.091 0.060 ASA grade 1.685 0.610–4.654 0.314 Operative procedure* 1.182 0.401–3.481 0.762 Post-op DGE 3.820 1.417–4.091 0.008 *Defined as either two- or three-stage esophagectomy requiring either thoracic or cervical anastomosis respectively. ASA, American Society of Anesthesiologists grade; DGE, delayed gastric emptying. View Large DISCUSSION Intraoperative pyloric stretching is a simple and safe procedure and is associated with significantly lower rates of postoperative DGE. Regardless of intraoperative intervention to the pylorus, DGE was associated with longer hospital stays and higher rates of pneumonia and cardiac complications, emphasizing the importance of efforts to prevent this complication. This study has sought to contribute evidence that an intraoperative pyloric stretch procedure can help to reduce the burden of DGE following esophagectomy. While the series reported by Langley et al.3 is larger than this study, it does not comment on outcomes that are relevant to postoperative DGE nor does it seek to provide comparison with a control population. Manjari et al. assessed gastric emptying in patients who had been randomly assigned to undergo pyloroplasty, pyloromyotomy, or pyloric stretch at the time of esophagectomy.4 The authors concluded that these interventions offered equivalent gastric emptying to liquids and solids when assessed 6–8 weeks after surgery. Overall conclusions drawn from their study were however limited due to the absence of a negative control group and comparison of many early and late postoperative outcomes. In this study, implementation of an intraoperative pyloric stretch procedure was not associated with any adverse outcomes. Previous studies that have investigated a role for intraoperative pyloric interventions likewise did not report any local complications related to this procedure.1 Notwithstanding there is evidence that disruption of pyloric function may promote reflux of duodenal and small bowel contents, including bile, into the conduit with subsequent risk of aspiration.5–7 Other studies have suggested that pyloric interventions performed at the time of esophagectomy can lead to higher rates of postoperative dumping syndrome.7,8 This is supported by the finding of faster gastric emptying in patients who have undergone such procedures.9–13 The presumed benefits of pyloric interventions performed at the time of esophagectomy should therefore always be weighed against their potential adverse effects. Intraoperative pyloric dilation did not appear to significantly influence the rate of pneumonia. DGE was however determined to be an independent predictor of postoperative pneumonia both by univariate and logistic regression analysis. Several factors may be contributing to these discordant findings. Firstly, the relatively small number of patients included in this study may a lack of appropriate statistical power to determine the true effect of pyloric dilation on rates of pneumonia. Secondly, important differences between the treatment groups, specifically a higher rate of smoking in patients who underwent intraoperative dilation may be a significant factor. While previous authors have demonstrated an association between DGE and rates of postoperative pneumonia,14,15 a finding that is broadly supported by this study, the current study does not however appear to provide evidence that an intraoperative pyloric stretch procedure reduces rates of postoperative pneumonia. The relationship between intraoperative pyloric drainage, DGE with the rate of postoperative cardiac complications appears to be similar to that observed for pneumonia. The finding of higher rates of cardiac complications, typically atrial fibrillation, in patients with DGE is assumed to reflex concurrent pulmonary complication as these two outcomes were closely related. The incidence of other complications, including anastomotic leak and recurrent laryngeal palsy/praxia were low in this study, limiting the ability to draw reliable conclusions regarding their association with DGE or other complications such as pneumonia. Operative method, two- or three-stage esophagectomy, did not appear to significantly affect the rate of postoperative DGE as rates of this outcome were similar for these groups. While all patients in this series underwent laparotomy during the abdominal stage of surgery, one patient in both the pyloric stretch and nonpyloric stretch groups underwent thoracoscopic mobilization of the thoracic esophagus. Surgical approach including minimally invasive techniques, anastomotic site, and the width of gastric conduit may however represent further modifiable factors that affect the development of DGE after esophagectomy.15–20 Such relationships should be the focus of future studies that potentially encompasses larger and more diverse patient cohorts. This study suffers from a number of important limitations. A retrospective assessment of a change in clinical practice is vulnerable to temporal variation in each of the patient cohorts as well as other known and unknown biases. A change in scheduling that occurred in April 2012 meant that surgeries were performed earlier in the week on a Monday as opposed to a Thursday. The departmental policy of performing a contrast swallow on postoperative day five (Tuesday) was therefore changed to four days to allow this investigation to be completed on Friday prior to the weekend. As little is known about the temporal variation of pyloric function following esophagectomy it is uncertain whether this change could have a significantly influenced findings. For patients with either a normal study or evidence of DGE, the median postoperative day upon which the first contrast swallow was performed was day five for both groups. While a standard technique was utilized when performing postoperative contrast swallows and all images were reviewed and verified by one of four consultant gastrointestinal radiologists, interpretation of this technique remains vulnerable to factors that are specific to the patient, procedure, and radiographic reporting. It is also noted that there is currently no standardized definition for DGE in patients who have undergone esophagectomy. As highlighted by Arya et al. a diverse range of criteria have been used to defined DGE in this setting. The application of institutional specific criteria, as in this study, limited the ability draw reliable comparisons between centers and serves to diminish the strength of evidence that can be inferred from individual studies. It is noted that all patients in this study with evidence of DGE following esophagectomy underwent radiologically guided pyloric balloon dilatation. Consideration for a graded approach to the assessment and management of DGE after esophagectomy is however advocated by some authors.5 Without consensus guidelines such variation in practice will continue to exist. Finally this study did not endeavor to determine the effects of an intraoperative pyloric stretch procedure of long-term functional disorders of the gastrointestinal tract including dumping syndrome. As well as early postoperative outcome, future studies should seek to determine the influence of intraoperative pyloric stretch on other important factors including consensus guidelines for assessment of gastric emptying after esophageal resection, economic costs, and long-term quality of life. In conclusion, this study has demonstrated the safety and efficacy an intraoperative pyloric stretch procedure for the prevention of DGE following esophagectomy with gastric reconstruction. Notes Specific author contributions: Study conception and design: Piers R. Boshier, George B. Hanna: Data collection: Piers R. Boshier, Mina E. Adam, Sophie Doran, Keerthini Muthuswamy; Data analysis: Piers R. Boshier, Mina E. Adam, Sophie Doran, Keerthini Muthuswamy; Drafting manuscript: Piers R. Boshier, Mina E. Adam; Authorization of final version of manuscript: Piers R. Boshier, Mina E. Adam, Sophie Doran, Keerthini Muthuswamy, George B. Hanna. References 1. Arya S , Markar S R , Karthikesalingam A , Hanna G B . The impact of pyloric drainage on clinical outcome following esophagectomy: a systematic review . Dis Esophagus 2015 ; 28 : 326 – 35 . Google Scholar Crossref Search ADS PubMed 2. Boshier P R , Huddy J R , Zaninotto G , Hanna G B . Dumping syndrome after esophagectomy: a systematic review of the literature . Dis Esophagus 2017 ; 30 : 1 – 9 . Google Scholar PubMed 3. Langley S M , Alexiou C , Bailey D H , Weeden D F . The influence of perioperative blood transfusion on survival after esophageal resection for carcinoma . Ann Thorac Surg 2002 ; 73 : 1704 – 9 . Google Scholar Crossref Search ADS PubMed 4. Manjari R , Padhy A K , Chattopadhyay T K . Emptying of the intrathoracic stomach using three different pylorus drainage procedures? Results of a comparative study . Surg Today 1996 ; 26 : 581 – 5 . Google Scholar Crossref Search ADS PubMed 5. Cerfolio R J , Bryant A S , Canon C L , Dhawan R , Eloubeidi M A . Is botulinum toxin injection of the pylorus during Ivor–Lewis esophagogastrectomy the optimal drainage strategy? J Thorac Cardiovasc Surg 2009 ; 137 : 565 – 72 . Google Scholar Crossref Search ADS PubMed 6. Palmes D , Weilinghoff M , ColomboBenkmann M , Senninger N , Bruewer M . Effect of pyloric drainage procedures on gastric passage and bile reflux after esophagectomy with gastric conduit reconstruction . Langenbecks Arch Surg 2007 ; 392 : 135 – 41 . Google Scholar Crossref Search ADS PubMed 7. Wang L S , Huang M H , Huang B S , Chien K Y . Gastric substitution for resectable carcinoma of the esophagus: an analysis of 368 cases . Ann Thorac Surg 1992 ; 53 : 289 – 94 . Google Scholar Crossref Search ADS PubMed 8. McLarty A J , Deschamps C , Trastek V F , Allen M S , Pairolero P C , Harmsen W S . Esophageal resection for cancer of the esophagus: longterm function and quality of life . Ann Thorac Surg 1997 ; 63 : 1568 – 71 . Google Scholar Crossref Search ADS PubMed 9. Cheung H C , Siu K F , Wong J . Is pyloroplasty necessary in esophageal replacement by stomach? A prospective, randomized controlled trial . Surgery 1987 ; 102 : 19 – 24 . Google Scholar PubMed 10. Deng B , Tan Q Y , Jiang Y G et al. Prevention of early delayed gastric emptying after HighLevel Esophagogastrostomy by “Pyloric Digital Fracture” . World J Surg 2010 ; 34 : 2837 – 43 . Google Scholar Crossref Search ADS PubMed 11. Fok M , Cheng S W , Wong J . Pyloroplasty versus no drainage in gastric replacement of the esophagus . Am J Surg 1991 ; 162 : 447 – 52 . Google Scholar Crossref Search ADS PubMed 12. Gupta S , Chattopadhyay T K , Gopinath P G , Kapoor V K , Sharma L K . Emptying of the intrathoracic stomach with and without pyloroplasty . Am J Gastroenterol 1989 ; 84 : 921 – 3 . Google Scholar PubMed 13. Kao C H , Chen C Y , Chen C L , Wang S J , Yeh S H . Gastric emptying of the intrathoracic stomach as oesophageal replacement for oesophageal carcinomas . Nucl Med Commun 1994 ; 15 : 152 – 5 . Google Scholar Crossref Search ADS PubMed 14. Benedix F , Willems T , Kropf S , Schubert D , Stubs P , Wolff S . Risk factors for delayed gastric emptying after esophagectomy . Langenbecks Arch Surg 2017 ; 402 : 547 – 54 . Google Scholar Crossref Search ADS PubMed 15. Li B , Zhang J H , Wang C et al. Delayed gastric emptying after esophagectomy for malignancy . J Laparoendosc Adv Surg Tech 2014 ; 24 : 306 – 11 . Google Scholar Crossref Search ADS 16. Yang X , Zhan C , Sun F et al. [Efficacy comparison of Sweet versus IvorLewis esophagectomy in the treatment of middlelower esophageal squamous cell carcinoma] . Zhonghua Wei Chang Wai Ke Za Zhi 2016 ; 19 ( 9 ): 979 – 84 . Google Scholar PubMed 17. Glatz T , Marjanovic G , Kulemann B , Sick O , Hopt U T , Hoeppner J . Hybrid minimally invasive esophagectomy vs. open esophagectomy: a matched case analysis in 120 patients . Langenbecks Arch Surg 2017 ; 402 : 323 – 31 . Google Scholar Crossref Search ADS PubMed 18. Zhang L , Hou S C , Miao J B , Lee H . Risk factors for delayed gastric emptying in patients undergoing esophagectomy without pyloric drainage . J Surg Res 2017 ; 213 : 46 – 50 . Google Scholar Crossref Search ADS PubMed 19. Zhen F , Shi S , Xue L , Liu J , Luo J . Study on the association of gastric conduit width and postoperative early delayed gastric emptying in middlelower esophageal cancer patients undergoing IvorLewis procedure . Zhonghua Wei Chang Wai Ke Za Zhi 2016 ; 19 : 985 – 9 . Google Scholar PubMed 20. Ma J , Zhan C , Wang L et al. The sweet approach is still worthwhile in modern esophagectomy . Ann Thorac Surg 2014 ; 97 : 1728 – 33 . Google Scholar Crossref Search ADS PubMed © The Author(s) 2018. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model) http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Diseases of the Esophagus Oxford University Press

Effects of intraoperative pyloric stretch procedure on outcomes after esophagectomy

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Oxford University Press
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© The Author(s) 2018. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus.
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1120-8694
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1442-2050
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10.1093/dote/doy038
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Abstract

Summary Various methods have been described to aid pyloric drainage in patients undergoing esophagectomy with gastric reconstruction. These techniques are intended to prevent delayed gastric empting following esophagectomy that can be associated with early morbidity and long-term functional complaints. The current study aims to review the safety and efficacy of a pyloric stretch procedure performed at the time of esophagectomy. To achieve this, a retrospective review of 100 consecutive patients undergoing esophagectomy during the period 2011–2016 was performed. Until May 2013, no patients received intraoperative pyloric intervention. After May 2013, all patients (N = 50) underwent intraoperative pyloric stretch procedure that involved bidirectional mechanical dilatation of the pylorus. Postoperative outcomes including result of routine oral contrast swallow and early morbidity were evaluated. Intraoperative pyloric stretching was performed safely and without local complications in all patients. Delayed gastric emptying was observed significantly less frequently in patients who received intraoperative pyloric stretching (48% vs. 22%, P = 0.006). No significant differences were observed in postoperative outcomes. When considering all patients as a single cohort, the presence of delayed gastric emptying was associated with significantly higher rates of postoperative pneumonia (71% vs. 45%, P = 0.010), cardiac complications (57% vs. 25%, P = 0.001) as well as longer hospital say (12 vs. 15 days, P < 0.001) and delay to free oral fluid intake (7 vs. 9 days, < 0.001). Binary logistic regression identified age and postoperative delayed gastric emptying as independent risk factors for postoperative pneumonia. In conclusion, this study has demonstrated the safety and efficacy an intraoperative pyloric stretch procedure for the prevention of delayed gastric emptying following esophagectomy. INTRODUCTION Esophagectomy with gastric reconstruction may often be associated with pyloric dysfunction leading to delayed gastric emptying (DGE). The mechanisms underlying this effect are poorly understood but are likely to be a consequence the combined denervation, tubularization, and reorientation of the stomach in an extra-anatomical position. These factors may contribute to pyloric spasm and gastric hypomotility. The occurrence and extent of pyloric dysfunction after esophagectomy varies between individual patients and is difficult to predict. Distension of the gastric conduit in the early postoperative period may lead to pressurization of the newly formed anastomosis and aspiration of intestinal contents into the lungs. For those patients who achieve long-term survival after esophagectomy, gastric dysfunction can also have a detrimental effect on quality of life with symptoms of early satiety and reflux. The nature and timing of intervention to aid pyloric drainage in the setting of esophagectomy is often a matter of preference for individual surgeons. While many would advocate a pre-emptive approach to this clinical problem at the time of esophagectomy others would support a more conservative strategy whereby patients are managed according to symptoms, clinical signs, and the findings of staged investigations. Among the numerous techniques described to promote pyloric drainage, the most common include intraoperative pyloroplasty and pyloromyotomy. The use of intraoperative and more often postoperative pyloric balloon dilatation and botulinum toxin injection is also widely described. Despite numerous reports of the use of these techniques, there is limited evidence to support their adoption in regard to improving postoperative DGE, anastomotic leak rate, and pulmonary complications.1 Furthermore, there is some evidence to suggest that intraoperative pyloric procedures may have detrimental effect relating to the higher occurrence rates of postoperative reflux and dumping syndrome.1,2 There have been several reports in the literature of the use of an intraoperative pyloric stretch procedure to aid postoperative gastric emptying.3,4 Potential benefits of this technique include the ability to apply direct mechanical dilation of the pylorus avoiding the need for incision of surrounding seromuscular tissues. It is hypothesized that intraoperative pyloric stretching will diminish the incidence of postoperative DGE and morbidity with which it is associated. The aim of this study therefore is determine the effect of a pyloric stretch procedure, performed at the time of esophagectomy, on postoperative outcomes including DGE, requirement for postoperative pyloric dilation and early morbidity. METHODOLOGY A retrospective review of 100 consecutive patients undergoing either two- or three-stage esophagectomy for esophageal cancer with radical lymphadenectomy and gastric pull-up between June 2011 and December 2016 under the care of a single surgeon (GH) was performed at St Mary's hospital. The surgical approach for tumors of the gastroesophageal junction and lower esophagus was two-stage (Ivor Lewis) esophagectomy with abdominal and thoracic (infracarinal) lymphadenectomy. For tumors of the lower- and mid-esophagus lymph node dissection was extended to the upper mediastinum and area surrounding the recurrent laryngeal nerves. Cervical lymphadenectomy via a three-staged surgical approach was performed only for tumors of the upper esophagus. Esophageal reconstruction in all cases was via single layer handsewn anastomosis performed either within the thoracic cavity or left cervical region in the case or two- and three-stage esophagectomy, respectively. A standard gastric conduit width between 4 and 5 cm was used in all cases. Introspective pyloric stretch procedure Prior to May 2013 patients undergoing esophagec-tomy were not subject to any form of intraoperative intervention to aid postoperative pyloric dilation. After May 2013 all patients underwent intraoperative pyloric stretch procedure as described by Manjari et al.4 In this cohort, this procedure was performed by passing a Rampleys sponge holding forceps through a gastrostomy that was created proximal to the intended gastric resection margin. The tips of this instrument were passed in to the pylorus and opened under sustained force in a cranial-caudal plane of direction for two minutes. This process was subsequently repeated within a perpendicular (anteroposterior) plane to ensure the intended circumferential dilation of the pylorus. Postoperative management including protocol for assessment of anastomotic integrity and pyloric drainage Postoperatively patients were initially managed within an intensive care unit. Patients were subsequently transferred to a high dependency unit and finally to a general surgical ward. All patients received analgesia via a thoracic epidural. In addition to thoracic and abdominal drains, nasogastric tube was used to decompress the gastric conduit. From postoperative day one, patients received either enteral nutrient via feeding jejunostomy placed at the time of surgery or total parenteral nutrition. An oral meglumine diatrizoate and diatrizoate sodium (Gastrografin; Bracco Diagnostics Inc.) contrast study was performed on either postoperative day four or five to assess for both anastomotic continuity and DGE. Where patients were not medically able to undergo oral contrast study at this time, for example due to delayed/reintubation, this investigation was deferred to the soonest appropriate future date. In patients with no evidence either anastomotic leak or DGE, oral intake was cautiously resumed initially with sips of clear fluid. In those patients found to have DGE, defined as excessively slow or absent flow of contrast into the first part of the duodenum after 15 minutes of consuming oral contrast, the nasogastric tube remained in situ on free drainage and oral intake continued to be withheld. As no standard definition exists for DGE after esophagectomy,1 criteria were determined in accordance with local practice but were informed by previous studies.5 These patients underwent radiologically guided pyloric balloon dilatation at the soonest available opportunity. A repeat oral contrast study was performed typically within 24 hours of balloon dilation to reassess gastric emptying. Oral intake was only reintroduced after successful demonstration of prompt (majority of contrast passing into the first part of the duodenum within <15 minutes) gastric emptying in the absence of anastomotic leak. In all patients progression to free oral fluids (including, liquids, clear soup, jelly, and ice cream) occurred only once patients were observed to have tolerated sips of clear fluid, typically by postoperative day 6 to 7. In patients with deviation from the predicted recovery course prompt investigation using computer tomography with intravenous and/or oral contrast was performed. After hospital discharge patients continued to receive supplementary home jejunal feeding until satisfactory oral intake had been achieved. Patients were followed up every three months for the first two years after resection and subsequently every six months until five years. In the absence of concerning clinical signs patients underwent yearly radiological surveillance with computer tomography. Full definitions of all postoperative complications are provided in an on-line supplementary file. The diagnosis of postoperative pneumonia was based on clinical (fever > 38°C, increased respiratory secretions or leukocytosis/leukopenia) and radiological (not atelectasis) evidence of chest infection, for which antibiotic therapy was started. Cardiac complications were considered as any acute ischemic event or new arrhythmias (both determined by clinical examination and a combination of electrocardiography, echocardiography, or serum troponins) requiring therapeutic intervention. Statistical analysis Statistical analysis was performed using SPSS (Version 24.0, IBM Corp., Armonk, USA). Continuous variables are presented as mean ± standard deviation unless otherwise stated. Chi-squared or Fishers exact tests were used to compare categorical data; Students t-test (parametric data) or the Mann–Whitney U test (nonparametric data) were used to compare continuous data. Binary logistic regression was used to determine variables predicative of postoperative pneumonia. Two-sided P values ≤ 0.05 were considered statistically significant. RESULTS Details of patient demographics and postoperative outcomes for each study cohort are presented in Table 1. With the exception of current/previous smoking habit patients groups were well match in terms of other baseline characteristics. Intraoperative pyloric stretch procedure was simple to perform and was not associated with adverse intraoperative outcomes. The total length of additional operative time required to perform this procedure was approximately 6 minutes per case. Table 1 Patient demographics and outcomes No intra-op dilation Intra-op dilation n = 50 n = 50 P value Age 62.7 ± 11.6 63.4 ± 10.5 0.755 Gender (M:F) 40/10 44/6 0.275 BMI 27.8 ± 4.7 27.9 ± 5.5 0.889 Current or exsmoker 29 38 0.024 Neoadjuvant therapy Chemotherapy 38 33 0.141 Chemoradiotherapy 1 6 ASA (2/3) 36/14 36/14 – Charlson comorbidity score 4.4 ± 1.5 [2–8] 4.1 ± 1.2 [2–8] 0.245 Surgical approach Two-stage oesophagectomy 36 40 0.349 Three-stage esophagectomy* 14 10 Histology Adenocarcinoma 36 41 0.492 Squamous cell carcinoma 8 5 Other 6 4 T0-is/T1/T2/T3/T4 1/12/8/25/4 5/13/4/25/3 0.382 N0/N1/N2/N3 19/18/7/6 24/12/10/4 0.438 Lymph nodes excised 67 (58–76) 63 (52–75) 0.142 Length of surgery including anesthesia (hours) 10.7 ± 1.4 10.6 ± 1.5 0.831 Length OLV (hours) 3.5 ± 0.8 3.2 ± 0.8 0.049 Urine output (mL) 1145 ± 623 786 ± 414 0.009 Intraoperative fluid (mL) 6149 ± 2043 5320 ± 2124 0.074 Length of ICU/HDU stay (days) 5 (3–7) 5 (2–6) 0.313 Length of hospital stay (day) 14 (11–22) 12 (10–15) 0.160 Post-op oral free fluids (day) 8 (7–9) 7 (6–9) 0.270 Delayed gastric emptying 24 (48) 11 (22) 0.006 In hospital mortality 0 (0) 0 (0) 0.495* Anastomotic leak 2 (4) 0 (0) 0.495* Unplanned return to theatre 1 (2) 1 (2) 1.000* Pneumonia 26 (52) 28 (56) 0.668 ARDS 0 (0) 1 (2) 1.000v Cardiac complication 21 (42) 15 (30) 0.211 Chyle leak 5 (10) 6 (12) 1.000* Pleural effusion 11 (22) 4 (8) 0.091* RLN-palsy/praxia 3 (6) 3 (6) 1.000* Haemorrhage 2 (2) 0 (0) 0.495* Wound infection 5 (10) 4 (8) 1.000* CVA 1 (2) 0 (0) 1.000* Acute renal failure 1 (2) 0 (0) 1.000* DVT/PE 2/0 (4/0) 1/1 (2/2) 1.000* No intra-op dilation Intra-op dilation n = 50 n = 50 P value Age 62.7 ± 11.6 63.4 ± 10.5 0.755 Gender (M:F) 40/10 44/6 0.275 BMI 27.8 ± 4.7 27.9 ± 5.5 0.889 Current or exsmoker 29 38 0.024 Neoadjuvant therapy Chemotherapy 38 33 0.141 Chemoradiotherapy 1 6 ASA (2/3) 36/14 36/14 – Charlson comorbidity score 4.4 ± 1.5 [2–8] 4.1 ± 1.2 [2–8] 0.245 Surgical approach Two-stage oesophagectomy 36 40 0.349 Three-stage esophagectomy* 14 10 Histology Adenocarcinoma 36 41 0.492 Squamous cell carcinoma 8 5 Other 6 4 T0-is/T1/T2/T3/T4 1/12/8/25/4 5/13/4/25/3 0.382 N0/N1/N2/N3 19/18/7/6 24/12/10/4 0.438 Lymph nodes excised 67 (58–76) 63 (52–75) 0.142 Length of surgery including anesthesia (hours) 10.7 ± 1.4 10.6 ± 1.5 0.831 Length OLV (hours) 3.5 ± 0.8 3.2 ± 0.8 0.049 Urine output (mL) 1145 ± 623 786 ± 414 0.009 Intraoperative fluid (mL) 6149 ± 2043 5320 ± 2124 0.074 Length of ICU/HDU stay (days) 5 (3–7) 5 (2–6) 0.313 Length of hospital stay (day) 14 (11–22) 12 (10–15) 0.160 Post-op oral free fluids (day) 8 (7–9) 7 (6–9) 0.270 Delayed gastric emptying 24 (48) 11 (22) 0.006 In hospital mortality 0 (0) 0 (0) 0.495* Anastomotic leak 2 (4) 0 (0) 0.495* Unplanned return to theatre 1 (2) 1 (2) 1.000* Pneumonia 26 (52) 28 (56) 0.668 ARDS 0 (0) 1 (2) 1.000v Cardiac complication 21 (42) 15 (30) 0.211 Chyle leak 5 (10) 6 (12) 1.000* Pleural effusion 11 (22) 4 (8) 0.091* RLN-palsy/praxia 3 (6) 3 (6) 1.000* Haemorrhage 2 (2) 0 (0) 0.495* Wound infection 5 (10) 4 (8) 1.000* CVA 1 (2) 0 (0) 1.000* Acute renal failure 1 (2) 0 (0) 1.000* DVT/PE 2/0 (4/0) 1/1 (2/2) 1.000* Values in parentheses are percentages. *A single patient from each group underwent thoracoscopic mobilization of the thoracic esophagus, the abdominal stage was however performed using the standard open approach. ARDS, adult respiratory distress syndrome; ASA, American Society of Anesthesiologists grade; BMI, body mass index; CVA, cerebrovascular accident; DVT, deep vein thrombosis; HDU, high dependency care unit; ICU, intensive care unit; MI, minimally invasive; OLV, one-lung ventilation; RLN, recurrent laryngeal nerve; PE, pulmonary embolism. View Large Table 1 Patient demographics and outcomes No intra-op dilation Intra-op dilation n = 50 n = 50 P value Age 62.7 ± 11.6 63.4 ± 10.5 0.755 Gender (M:F) 40/10 44/6 0.275 BMI 27.8 ± 4.7 27.9 ± 5.5 0.889 Current or exsmoker 29 38 0.024 Neoadjuvant therapy Chemotherapy 38 33 0.141 Chemoradiotherapy 1 6 ASA (2/3) 36/14 36/14 – Charlson comorbidity score 4.4 ± 1.5 [2–8] 4.1 ± 1.2 [2–8] 0.245 Surgical approach Two-stage oesophagectomy 36 40 0.349 Three-stage esophagectomy* 14 10 Histology Adenocarcinoma 36 41 0.492 Squamous cell carcinoma 8 5 Other 6 4 T0-is/T1/T2/T3/T4 1/12/8/25/4 5/13/4/25/3 0.382 N0/N1/N2/N3 19/18/7/6 24/12/10/4 0.438 Lymph nodes excised 67 (58–76) 63 (52–75) 0.142 Length of surgery including anesthesia (hours) 10.7 ± 1.4 10.6 ± 1.5 0.831 Length OLV (hours) 3.5 ± 0.8 3.2 ± 0.8 0.049 Urine output (mL) 1145 ± 623 786 ± 414 0.009 Intraoperative fluid (mL) 6149 ± 2043 5320 ± 2124 0.074 Length of ICU/HDU stay (days) 5 (3–7) 5 (2–6) 0.313 Length of hospital stay (day) 14 (11–22) 12 (10–15) 0.160 Post-op oral free fluids (day) 8 (7–9) 7 (6–9) 0.270 Delayed gastric emptying 24 (48) 11 (22) 0.006 In hospital mortality 0 (0) 0 (0) 0.495* Anastomotic leak 2 (4) 0 (0) 0.495* Unplanned return to theatre 1 (2) 1 (2) 1.000* Pneumonia 26 (52) 28 (56) 0.668 ARDS 0 (0) 1 (2) 1.000v Cardiac complication 21 (42) 15 (30) 0.211 Chyle leak 5 (10) 6 (12) 1.000* Pleural effusion 11 (22) 4 (8) 0.091* RLN-palsy/praxia 3 (6) 3 (6) 1.000* Haemorrhage 2 (2) 0 (0) 0.495* Wound infection 5 (10) 4 (8) 1.000* CVA 1 (2) 0 (0) 1.000* Acute renal failure 1 (2) 0 (0) 1.000* DVT/PE 2/0 (4/0) 1/1 (2/2) 1.000* No intra-op dilation Intra-op dilation n = 50 n = 50 P value Age 62.7 ± 11.6 63.4 ± 10.5 0.755 Gender (M:F) 40/10 44/6 0.275 BMI 27.8 ± 4.7 27.9 ± 5.5 0.889 Current or exsmoker 29 38 0.024 Neoadjuvant therapy Chemotherapy 38 33 0.141 Chemoradiotherapy 1 6 ASA (2/3) 36/14 36/14 – Charlson comorbidity score 4.4 ± 1.5 [2–8] 4.1 ± 1.2 [2–8] 0.245 Surgical approach Two-stage oesophagectomy 36 40 0.349 Three-stage esophagectomy* 14 10 Histology Adenocarcinoma 36 41 0.492 Squamous cell carcinoma 8 5 Other 6 4 T0-is/T1/T2/T3/T4 1/12/8/25/4 5/13/4/25/3 0.382 N0/N1/N2/N3 19/18/7/6 24/12/10/4 0.438 Lymph nodes excised 67 (58–76) 63 (52–75) 0.142 Length of surgery including anesthesia (hours) 10.7 ± 1.4 10.6 ± 1.5 0.831 Length OLV (hours) 3.5 ± 0.8 3.2 ± 0.8 0.049 Urine output (mL) 1145 ± 623 786 ± 414 0.009 Intraoperative fluid (mL) 6149 ± 2043 5320 ± 2124 0.074 Length of ICU/HDU stay (days) 5 (3–7) 5 (2–6) 0.313 Length of hospital stay (day) 14 (11–22) 12 (10–15) 0.160 Post-op oral free fluids (day) 8 (7–9) 7 (6–9) 0.270 Delayed gastric emptying 24 (48) 11 (22) 0.006 In hospital mortality 0 (0) 0 (0) 0.495* Anastomotic leak 2 (4) 0 (0) 0.495* Unplanned return to theatre 1 (2) 1 (2) 1.000* Pneumonia 26 (52) 28 (56) 0.668 ARDS 0 (0) 1 (2) 1.000v Cardiac complication 21 (42) 15 (30) 0.211 Chyle leak 5 (10) 6 (12) 1.000* Pleural effusion 11 (22) 4 (8) 0.091* RLN-palsy/praxia 3 (6) 3 (6) 1.000* Haemorrhage 2 (2) 0 (0) 0.495* Wound infection 5 (10) 4 (8) 1.000* CVA 1 (2) 0 (0) 1.000* Acute renal failure 1 (2) 0 (0) 1.000* DVT/PE 2/0 (4/0) 1/1 (2/2) 1.000* Values in parentheses are percentages. *A single patient from each group underwent thoracoscopic mobilization of the thoracic esophagus, the abdominal stage was however performed using the standard open approach. ARDS, adult respiratory distress syndrome; ASA, American Society of Anesthesiologists grade; BMI, body mass index; CVA, cerebrovascular accident; DVT, deep vein thrombosis; HDU, high dependency care unit; ICU, intensive care unit; MI, minimally invasive; OLV, one-lung ventilation; RLN, recurrent laryngeal nerve; PE, pulmonary embolism. View Large Patients in the initial group who did not undergo intraoperative pyloric stretch procedure tended to have a greater volume of intraoperative fluid (P = 0.074) and longer duration of one-lung ventilation (P = 0.049). Postoperative ICU/HDU and hospital stay were equivalent between the two study groups as were postoperative complications. There was no in hospital mortality. Two patients died following hospital discharge but within 90 days of surgery: one death was due to cardiac arrest following myocardial infarction which occurred three weeks following surgery (confirmed on postmortem examination) and the second death occurred seven weeks following surgery as a result of hemophagocytic lymphohistiocytosis, a rare hematological disorder (confirmed on bone marrow biopsy). DGE was observed in 24 (48%) patients who underwent surgery prior to in introduction of intraoperative pyloric stretching and in 11 (22%) patients who received this intervention (P = 0.006). All patients who had evidence of DGE underwent radiologically guided pyloric balloon dilatation. With the exception of one patient who required two postoperative dilatations, single postoperative pyloric dilation resulted in resolution of DGE as assessed by repeat contrast swallow. The occurrence of postoperative pyloric DGE (n = 35), regardless of whether intraoperative dilatation was performed, was associated with longer postoperative ICU/HDU (P = 0.005) and hospital (P < 0.001) stay as well as a significantly longer interval to postoperative oral fluid intake (P < 0.001) (Table 2). Patients with DGE were more likely to have postoperative pneumonia (71% vs. 45%, P = 0.010) and cardiac complications (57% vs. 25%, P = 0.001). Binary logistic regression of revealed age and postoperative DGE were independent risk factors for postoperative pneumonia (Table 3). Table 2 Patient demographics and outcomes based on the presence or absence of postoperative delayed gastric emptying No delayed gastric Delayed gastric emptying n = 65 emptying n = 35 P Age 63.0 ± 10.5 63.0 ± 11.5 0.968 Gender (M:F) 53:12 31:4 0.408* BMI 27.8 ± 4.7 27.9 ± 5.6 0.952 Current or exsmoker 44 23 0.674 Neoadjuvant therapy Chemotherapy 45 26 0.492 Chemoradiotherapy 6 1 ASA (2/3) 50:15 22:13 0.135 Charlson co-morbidity score 4.2 ± 1.3 [2–8] 4.3 ± 1.5 [2–8] 0.627 Surgical approach Two-stage esophagectomy 48 28 0.492 Three-stage esophagectomy1 17 7 Histology 48 29 0.559 Adenocarcinoma 10 3 Squamous cell carcinoma 7 3 Other T0-is/T1/T2/T3/T4 3/16/6/35/5 3/9/6/15/2 0.650 N0/N1/N2/N3 27/18/12/8 16/12/5/2 0.649 Lymph nodes excised 64 (55–75) 66 (56–76) 0.848 Length of surgery (hours) 10.7 ± 1.4 10.6 ± 1.5 0.025 Length OLV (hours) 3.5 ± 0.8 3.2 ± 0.8 0.032 Urine output (mL) 991 ± 545 1039 ± 636 0.729 Intraoperative fluid (mL) 5691 ± 2233 5934 ± 1924 0.611 Length of ICU/HDU stay (days) 4 (2–6) 6 (3–8) 0.005 Length of hospital stay (day) 12 (10–14) 15 (13–28) <0.001 Post-op oral fluid intake (day) 7 (6–8) 9 (8–11) <0.001 In hospital mortality 0 (0) 0 (0) 1.000* Anastomotic leak 0 (0) 2 (6) 0.120* Unplanned return to theatre 2 (3) 0 (0) 0.540* Pneumonia 29 (45) 25 (71) 0.010 ARDS 1 (2) 0 (0) 1.000* Cardiac complication 16 (25) 20 (57) 0.001 Chyle leak 9 (14) 2 (6) 0.320* Pleural effusion 8 (12) 7 (20) 0.304 RLN-palsy/praxia 4 (6) 2 (6) 1.000* Haemorrhage 0 (0) 2 (6) 0.120* Wound infection 5 (8) 4 (11) 0.716* CVA 1 (2) 0 (0) 1.000* Acute renal failure 0 (0) 1 (3) 0.350* DVT/PE 1/1 (2/2) 2/0 (6/0) >0.200* No delayed gastric Delayed gastric emptying n = 65 emptying n = 35 P Age 63.0 ± 10.5 63.0 ± 11.5 0.968 Gender (M:F) 53:12 31:4 0.408* BMI 27.8 ± 4.7 27.9 ± 5.6 0.952 Current or exsmoker 44 23 0.674 Neoadjuvant therapy Chemotherapy 45 26 0.492 Chemoradiotherapy 6 1 ASA (2/3) 50:15 22:13 0.135 Charlson co-morbidity score 4.2 ± 1.3 [2–8] 4.3 ± 1.5 [2–8] 0.627 Surgical approach Two-stage esophagectomy 48 28 0.492 Three-stage esophagectomy1 17 7 Histology 48 29 0.559 Adenocarcinoma 10 3 Squamous cell carcinoma 7 3 Other T0-is/T1/T2/T3/T4 3/16/6/35/5 3/9/6/15/2 0.650 N0/N1/N2/N3 27/18/12/8 16/12/5/2 0.649 Lymph nodes excised 64 (55–75) 66 (56–76) 0.848 Length of surgery (hours) 10.7 ± 1.4 10.6 ± 1.5 0.025 Length OLV (hours) 3.5 ± 0.8 3.2 ± 0.8 0.032 Urine output (mL) 991 ± 545 1039 ± 636 0.729 Intraoperative fluid (mL) 5691 ± 2233 5934 ± 1924 0.611 Length of ICU/HDU stay (days) 4 (2–6) 6 (3–8) 0.005 Length of hospital stay (day) 12 (10–14) 15 (13–28) <0.001 Post-op oral fluid intake (day) 7 (6–8) 9 (8–11) <0.001 In hospital mortality 0 (0) 0 (0) 1.000* Anastomotic leak 0 (0) 2 (6) 0.120* Unplanned return to theatre 2 (3) 0 (0) 0.540* Pneumonia 29 (45) 25 (71) 0.010 ARDS 1 (2) 0 (0) 1.000* Cardiac complication 16 (25) 20 (57) 0.001 Chyle leak 9 (14) 2 (6) 0.320* Pleural effusion 8 (12) 7 (20) 0.304 RLN-palsy/praxia 4 (6) 2 (6) 1.000* Haemorrhage 0 (0) 2 (6) 0.120* Wound infection 5 (8) 4 (11) 0.716* CVA 1 (2) 0 (0) 1.000* Acute renal failure 0 (0) 1 (3) 0.350* DVT/PE 1/1 (2/2) 2/0 (6/0) >0.200* Values in parentheses are percentages. *A single patient from each group underwent thoracoscopic mobilization of the thoracic esophagus, the abdominal stage was however performed using the standard open approach. ASA, American Society of Anesthesiologists grade; ARDS, adult respiratory distress syndrome; BMI, body mass index; CVA, cerebrovascular accident; DVT, deep vein thrombosis; ICU, intensive care unit; HDU, high dependency care unit; MI, minimally invasive; OLV, one-lung ventilation; PE, pulmonary embolism; RLN, recurrent laryngeal nerve. View Large Table 2 Patient demographics and outcomes based on the presence or absence of postoperative delayed gastric emptying No delayed gastric Delayed gastric emptying n = 65 emptying n = 35 P Age 63.0 ± 10.5 63.0 ± 11.5 0.968 Gender (M:F) 53:12 31:4 0.408* BMI 27.8 ± 4.7 27.9 ± 5.6 0.952 Current or exsmoker 44 23 0.674 Neoadjuvant therapy Chemotherapy 45 26 0.492 Chemoradiotherapy 6 1 ASA (2/3) 50:15 22:13 0.135 Charlson co-morbidity score 4.2 ± 1.3 [2–8] 4.3 ± 1.5 [2–8] 0.627 Surgical approach Two-stage esophagectomy 48 28 0.492 Three-stage esophagectomy1 17 7 Histology 48 29 0.559 Adenocarcinoma 10 3 Squamous cell carcinoma 7 3 Other T0-is/T1/T2/T3/T4 3/16/6/35/5 3/9/6/15/2 0.650 N0/N1/N2/N3 27/18/12/8 16/12/5/2 0.649 Lymph nodes excised 64 (55–75) 66 (56–76) 0.848 Length of surgery (hours) 10.7 ± 1.4 10.6 ± 1.5 0.025 Length OLV (hours) 3.5 ± 0.8 3.2 ± 0.8 0.032 Urine output (mL) 991 ± 545 1039 ± 636 0.729 Intraoperative fluid (mL) 5691 ± 2233 5934 ± 1924 0.611 Length of ICU/HDU stay (days) 4 (2–6) 6 (3–8) 0.005 Length of hospital stay (day) 12 (10–14) 15 (13–28) <0.001 Post-op oral fluid intake (day) 7 (6–8) 9 (8–11) <0.001 In hospital mortality 0 (0) 0 (0) 1.000* Anastomotic leak 0 (0) 2 (6) 0.120* Unplanned return to theatre 2 (3) 0 (0) 0.540* Pneumonia 29 (45) 25 (71) 0.010 ARDS 1 (2) 0 (0) 1.000* Cardiac complication 16 (25) 20 (57) 0.001 Chyle leak 9 (14) 2 (6) 0.320* Pleural effusion 8 (12) 7 (20) 0.304 RLN-palsy/praxia 4 (6) 2 (6) 1.000* Haemorrhage 0 (0) 2 (6) 0.120* Wound infection 5 (8) 4 (11) 0.716* CVA 1 (2) 0 (0) 1.000* Acute renal failure 0 (0) 1 (3) 0.350* DVT/PE 1/1 (2/2) 2/0 (6/0) >0.200* No delayed gastric Delayed gastric emptying n = 65 emptying n = 35 P Age 63.0 ± 10.5 63.0 ± 11.5 0.968 Gender (M:F) 53:12 31:4 0.408* BMI 27.8 ± 4.7 27.9 ± 5.6 0.952 Current or exsmoker 44 23 0.674 Neoadjuvant therapy Chemotherapy 45 26 0.492 Chemoradiotherapy 6 1 ASA (2/3) 50:15 22:13 0.135 Charlson co-morbidity score 4.2 ± 1.3 [2–8] 4.3 ± 1.5 [2–8] 0.627 Surgical approach Two-stage esophagectomy 48 28 0.492 Three-stage esophagectomy1 17 7 Histology 48 29 0.559 Adenocarcinoma 10 3 Squamous cell carcinoma 7 3 Other T0-is/T1/T2/T3/T4 3/16/6/35/5 3/9/6/15/2 0.650 N0/N1/N2/N3 27/18/12/8 16/12/5/2 0.649 Lymph nodes excised 64 (55–75) 66 (56–76) 0.848 Length of surgery (hours) 10.7 ± 1.4 10.6 ± 1.5 0.025 Length OLV (hours) 3.5 ± 0.8 3.2 ± 0.8 0.032 Urine output (mL) 991 ± 545 1039 ± 636 0.729 Intraoperative fluid (mL) 5691 ± 2233 5934 ± 1924 0.611 Length of ICU/HDU stay (days) 4 (2–6) 6 (3–8) 0.005 Length of hospital stay (day) 12 (10–14) 15 (13–28) <0.001 Post-op oral fluid intake (day) 7 (6–8) 9 (8–11) <0.001 In hospital mortality 0 (0) 0 (0) 1.000* Anastomotic leak 0 (0) 2 (6) 0.120* Unplanned return to theatre 2 (3) 0 (0) 0.540* Pneumonia 29 (45) 25 (71) 0.010 ARDS 1 (2) 0 (0) 1.000* Cardiac complication 16 (25) 20 (57) 0.001 Chyle leak 9 (14) 2 (6) 0.320* Pleural effusion 8 (12) 7 (20) 0.304 RLN-palsy/praxia 4 (6) 2 (6) 1.000* Haemorrhage 0 (0) 2 (6) 0.120* Wound infection 5 (8) 4 (11) 0.716* CVA 1 (2) 0 (0) 1.000* Acute renal failure 0 (0) 1 (3) 0.350* DVT/PE 1/1 (2/2) 2/0 (6/0) >0.200* Values in parentheses are percentages. *A single patient from each group underwent thoracoscopic mobilization of the thoracic esophagus, the abdominal stage was however performed using the standard open approach. ASA, American Society of Anesthesiologists grade; ARDS, adult respiratory distress syndrome; BMI, body mass index; CVA, cerebrovascular accident; DVT, deep vein thrombosis; ICU, intensive care unit; HDU, high dependency care unit; MI, minimally invasive; OLV, one-lung ventilation; PE, pulmonary embolism; RLN, recurrent laryngeal nerve. View Large Table 3 Multivariate analysis of factors predictive of postoperative pneumonia Odds ratio 95% confidence interval P Intra-op pyloric stretch 1.917 0.710–5.177 0.199 Age 0.902 0.823–0.988 0.027 Gender 0.982 0.279–3.452 0.977 Smoking history 1.809 0.686–4.765 0.231 Charlson comorbidity index 1.995 0.973–4.091 0.060 ASA grade 1.685 0.610–4.654 0.314 Operative procedure* 1.182 0.401–3.481 0.762 Post-op DGE 3.820 1.417–4.091 0.008 Odds ratio 95% confidence interval P Intra-op pyloric stretch 1.917 0.710–5.177 0.199 Age 0.902 0.823–0.988 0.027 Gender 0.982 0.279–3.452 0.977 Smoking history 1.809 0.686–4.765 0.231 Charlson comorbidity index 1.995 0.973–4.091 0.060 ASA grade 1.685 0.610–4.654 0.314 Operative procedure* 1.182 0.401–3.481 0.762 Post-op DGE 3.820 1.417–4.091 0.008 *Defined as either two- or three-stage esophagectomy requiring either thoracic or cervical anastomosis respectively. ASA, American Society of Anesthesiologists grade; DGE, delayed gastric emptying. View Large Table 3 Multivariate analysis of factors predictive of postoperative pneumonia Odds ratio 95% confidence interval P Intra-op pyloric stretch 1.917 0.710–5.177 0.199 Age 0.902 0.823–0.988 0.027 Gender 0.982 0.279–3.452 0.977 Smoking history 1.809 0.686–4.765 0.231 Charlson comorbidity index 1.995 0.973–4.091 0.060 ASA grade 1.685 0.610–4.654 0.314 Operative procedure* 1.182 0.401–3.481 0.762 Post-op DGE 3.820 1.417–4.091 0.008 Odds ratio 95% confidence interval P Intra-op pyloric stretch 1.917 0.710–5.177 0.199 Age 0.902 0.823–0.988 0.027 Gender 0.982 0.279–3.452 0.977 Smoking history 1.809 0.686–4.765 0.231 Charlson comorbidity index 1.995 0.973–4.091 0.060 ASA grade 1.685 0.610–4.654 0.314 Operative procedure* 1.182 0.401–3.481 0.762 Post-op DGE 3.820 1.417–4.091 0.008 *Defined as either two- or three-stage esophagectomy requiring either thoracic or cervical anastomosis respectively. ASA, American Society of Anesthesiologists grade; DGE, delayed gastric emptying. View Large DISCUSSION Intraoperative pyloric stretching is a simple and safe procedure and is associated with significantly lower rates of postoperative DGE. Regardless of intraoperative intervention to the pylorus, DGE was associated with longer hospital stays and higher rates of pneumonia and cardiac complications, emphasizing the importance of efforts to prevent this complication. This study has sought to contribute evidence that an intraoperative pyloric stretch procedure can help to reduce the burden of DGE following esophagectomy. While the series reported by Langley et al.3 is larger than this study, it does not comment on outcomes that are relevant to postoperative DGE nor does it seek to provide comparison with a control population. Manjari et al. assessed gastric emptying in patients who had been randomly assigned to undergo pyloroplasty, pyloromyotomy, or pyloric stretch at the time of esophagectomy.4 The authors concluded that these interventions offered equivalent gastric emptying to liquids and solids when assessed 6–8 weeks after surgery. Overall conclusions drawn from their study were however limited due to the absence of a negative control group and comparison of many early and late postoperative outcomes. In this study, implementation of an intraoperative pyloric stretch procedure was not associated with any adverse outcomes. Previous studies that have investigated a role for intraoperative pyloric interventions likewise did not report any local complications related to this procedure.1 Notwithstanding there is evidence that disruption of pyloric function may promote reflux of duodenal and small bowel contents, including bile, into the conduit with subsequent risk of aspiration.5–7 Other studies have suggested that pyloric interventions performed at the time of esophagectomy can lead to higher rates of postoperative dumping syndrome.7,8 This is supported by the finding of faster gastric emptying in patients who have undergone such procedures.9–13 The presumed benefits of pyloric interventions performed at the time of esophagectomy should therefore always be weighed against their potential adverse effects. Intraoperative pyloric dilation did not appear to significantly influence the rate of pneumonia. DGE was however determined to be an independent predictor of postoperative pneumonia both by univariate and logistic regression analysis. Several factors may be contributing to these discordant findings. Firstly, the relatively small number of patients included in this study may a lack of appropriate statistical power to determine the true effect of pyloric dilation on rates of pneumonia. Secondly, important differences between the treatment groups, specifically a higher rate of smoking in patients who underwent intraoperative dilation may be a significant factor. While previous authors have demonstrated an association between DGE and rates of postoperative pneumonia,14,15 a finding that is broadly supported by this study, the current study does not however appear to provide evidence that an intraoperative pyloric stretch procedure reduces rates of postoperative pneumonia. The relationship between intraoperative pyloric drainage, DGE with the rate of postoperative cardiac complications appears to be similar to that observed for pneumonia. The finding of higher rates of cardiac complications, typically atrial fibrillation, in patients with DGE is assumed to reflex concurrent pulmonary complication as these two outcomes were closely related. The incidence of other complications, including anastomotic leak and recurrent laryngeal palsy/praxia were low in this study, limiting the ability to draw reliable conclusions regarding their association with DGE or other complications such as pneumonia. Operative method, two- or three-stage esophagectomy, did not appear to significantly affect the rate of postoperative DGE as rates of this outcome were similar for these groups. While all patients in this series underwent laparotomy during the abdominal stage of surgery, one patient in both the pyloric stretch and nonpyloric stretch groups underwent thoracoscopic mobilization of the thoracic esophagus. Surgical approach including minimally invasive techniques, anastomotic site, and the width of gastric conduit may however represent further modifiable factors that affect the development of DGE after esophagectomy.15–20 Such relationships should be the focus of future studies that potentially encompasses larger and more diverse patient cohorts. This study suffers from a number of important limitations. A retrospective assessment of a change in clinical practice is vulnerable to temporal variation in each of the patient cohorts as well as other known and unknown biases. A change in scheduling that occurred in April 2012 meant that surgeries were performed earlier in the week on a Monday as opposed to a Thursday. The departmental policy of performing a contrast swallow on postoperative day five (Tuesday) was therefore changed to four days to allow this investigation to be completed on Friday prior to the weekend. As little is known about the temporal variation of pyloric function following esophagectomy it is uncertain whether this change could have a significantly influenced findings. For patients with either a normal study or evidence of DGE, the median postoperative day upon which the first contrast swallow was performed was day five for both groups. While a standard technique was utilized when performing postoperative contrast swallows and all images were reviewed and verified by one of four consultant gastrointestinal radiologists, interpretation of this technique remains vulnerable to factors that are specific to the patient, procedure, and radiographic reporting. It is also noted that there is currently no standardized definition for DGE in patients who have undergone esophagectomy. As highlighted by Arya et al. a diverse range of criteria have been used to defined DGE in this setting. The application of institutional specific criteria, as in this study, limited the ability draw reliable comparisons between centers and serves to diminish the strength of evidence that can be inferred from individual studies. It is noted that all patients in this study with evidence of DGE following esophagectomy underwent radiologically guided pyloric balloon dilatation. Consideration for a graded approach to the assessment and management of DGE after esophagectomy is however advocated by some authors.5 Without consensus guidelines such variation in practice will continue to exist. Finally this study did not endeavor to determine the effects of an intraoperative pyloric stretch procedure of long-term functional disorders of the gastrointestinal tract including dumping syndrome. As well as early postoperative outcome, future studies should seek to determine the influence of intraoperative pyloric stretch on other important factors including consensus guidelines for assessment of gastric emptying after esophageal resection, economic costs, and long-term quality of life. In conclusion, this study has demonstrated the safety and efficacy an intraoperative pyloric stretch procedure for the prevention of DGE following esophagectomy with gastric reconstruction. Notes Specific author contributions: Study conception and design: Piers R. Boshier, George B. Hanna: Data collection: Piers R. Boshier, Mina E. Adam, Sophie Doran, Keerthini Muthuswamy; Data analysis: Piers R. Boshier, Mina E. Adam, Sophie Doran, Keerthini Muthuswamy; Drafting manuscript: Piers R. Boshier, Mina E. Adam; Authorization of final version of manuscript: Piers R. Boshier, Mina E. Adam, Sophie Doran, Keerthini Muthuswamy, George B. Hanna. References 1. Arya S , Markar S R , Karthikesalingam A , Hanna G B . The impact of pyloric drainage on clinical outcome following esophagectomy: a systematic review . Dis Esophagus 2015 ; 28 : 326 – 35 . Google Scholar Crossref Search ADS PubMed 2. Boshier P R , Huddy J R , Zaninotto G , Hanna G B . Dumping syndrome after esophagectomy: a systematic review of the literature . Dis Esophagus 2017 ; 30 : 1 – 9 . Google Scholar PubMed 3. Langley S M , Alexiou C , Bailey D H , Weeden D F . The influence of perioperative blood transfusion on survival after esophageal resection for carcinoma . Ann Thorac Surg 2002 ; 73 : 1704 – 9 . Google Scholar Crossref Search ADS PubMed 4. Manjari R , Padhy A K , Chattopadhyay T K . Emptying of the intrathoracic stomach using three different pylorus drainage procedures? Results of a comparative study . Surg Today 1996 ; 26 : 581 – 5 . Google Scholar Crossref Search ADS PubMed 5. Cerfolio R J , Bryant A S , Canon C L , Dhawan R , Eloubeidi M A . Is botulinum toxin injection of the pylorus during Ivor–Lewis esophagogastrectomy the optimal drainage strategy? J Thorac Cardiovasc Surg 2009 ; 137 : 565 – 72 . Google Scholar Crossref Search ADS PubMed 6. Palmes D , Weilinghoff M , ColomboBenkmann M , Senninger N , Bruewer M . Effect of pyloric drainage procedures on gastric passage and bile reflux after esophagectomy with gastric conduit reconstruction . Langenbecks Arch Surg 2007 ; 392 : 135 – 41 . Google Scholar Crossref Search ADS PubMed 7. Wang L S , Huang M H , Huang B S , Chien K Y . Gastric substitution for resectable carcinoma of the esophagus: an analysis of 368 cases . Ann Thorac Surg 1992 ; 53 : 289 – 94 . Google Scholar Crossref Search ADS PubMed 8. McLarty A J , Deschamps C , Trastek V F , Allen M S , Pairolero P C , Harmsen W S . Esophageal resection for cancer of the esophagus: longterm function and quality of life . Ann Thorac Surg 1997 ; 63 : 1568 – 71 . Google Scholar Crossref Search ADS PubMed 9. Cheung H C , Siu K F , Wong J . Is pyloroplasty necessary in esophageal replacement by stomach? A prospective, randomized controlled trial . Surgery 1987 ; 102 : 19 – 24 . Google Scholar PubMed 10. Deng B , Tan Q Y , Jiang Y G et al. Prevention of early delayed gastric emptying after HighLevel Esophagogastrostomy by “Pyloric Digital Fracture” . World J Surg 2010 ; 34 : 2837 – 43 . Google Scholar Crossref Search ADS PubMed 11. Fok M , Cheng S W , Wong J . Pyloroplasty versus no drainage in gastric replacement of the esophagus . Am J Surg 1991 ; 162 : 447 – 52 . Google Scholar Crossref Search ADS PubMed 12. Gupta S , Chattopadhyay T K , Gopinath P G , Kapoor V K , Sharma L K . Emptying of the intrathoracic stomach with and without pyloroplasty . Am J Gastroenterol 1989 ; 84 : 921 – 3 . Google Scholar PubMed 13. Kao C H , Chen C Y , Chen C L , Wang S J , Yeh S H . Gastric emptying of the intrathoracic stomach as oesophageal replacement for oesophageal carcinomas . Nucl Med Commun 1994 ; 15 : 152 – 5 . Google Scholar Crossref Search ADS PubMed 14. Benedix F , Willems T , Kropf S , Schubert D , Stubs P , Wolff S . Risk factors for delayed gastric emptying after esophagectomy . Langenbecks Arch Surg 2017 ; 402 : 547 – 54 . Google Scholar Crossref Search ADS PubMed 15. Li B , Zhang J H , Wang C et al. Delayed gastric emptying after esophagectomy for malignancy . J Laparoendosc Adv Surg Tech 2014 ; 24 : 306 – 11 . Google Scholar Crossref Search ADS 16. Yang X , Zhan C , Sun F et al. [Efficacy comparison of Sweet versus IvorLewis esophagectomy in the treatment of middlelower esophageal squamous cell carcinoma] . Zhonghua Wei Chang Wai Ke Za Zhi 2016 ; 19 ( 9 ): 979 – 84 . Google Scholar PubMed 17. Glatz T , Marjanovic G , Kulemann B , Sick O , Hopt U T , Hoeppner J . Hybrid minimally invasive esophagectomy vs. open esophagectomy: a matched case analysis in 120 patients . Langenbecks Arch Surg 2017 ; 402 : 323 – 31 . Google Scholar Crossref Search ADS PubMed 18. Zhang L , Hou S C , Miao J B , Lee H . Risk factors for delayed gastric emptying in patients undergoing esophagectomy without pyloric drainage . J Surg Res 2017 ; 213 : 46 – 50 . Google Scholar Crossref Search ADS PubMed 19. Zhen F , Shi S , Xue L , Liu J , Luo J . Study on the association of gastric conduit width and postoperative early delayed gastric emptying in middlelower esophageal cancer patients undergoing IvorLewis procedure . Zhonghua Wei Chang Wai Ke Za Zhi 2016 ; 19 : 985 – 9 . Google Scholar PubMed 20. Ma J , Zhan C , Wang L et al. The sweet approach is still worthwhile in modern esophagectomy . Ann Thorac Surg 2014 ; 97 : 1728 – 33 . Google Scholar Crossref Search ADS PubMed © The Author(s) 2018. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model)

Journal

Diseases of the EsophagusOxford University Press

Published: Oct 1, 2018

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