Background Staple line leakage after bariatric surgery can be treated by endoscopic placement of a self-expandable stent. The success rate of stent placement is generally high, but migration is a frequent adverse event that hampers successful treatment. The Niti-S Beta stent is a fully covered double-bump stent that was specifically designed to prevent migration. This study aimed to evaluate the effectiveness and adverse event rate of the Niti-S Beta stent. Methods A retrospective study was performed in three high-volume bariatric centers. All consecutive patients between 2009 and 2016 who underwent placement of a Beta stent for staple line leakage were included. Primary outcome was resolution of the leakage; secondary outcome was the adverse event rate including migration. Results Thirty-eight patients were included. Twenty-five (66%) had resolution of the leakage. Success rate was higher in patients who were treated with implantation of a Beta stent as initial treatment (100%) than in patients who were treated with a stent after revisional surgery had failed (55%, p = 0.013). Migration occurred in 12 patients (32%). There were two severe adverse events requiring surgical intervention, including a bleeding from an aorto-esophageal fistula. Conclusions The success rate and the migration rate of the Beta stent seem comparable to other stents in this retrospective study. Despite the novel double-bump structure of the stent, the migration rate does not seem to be decreased. Keywords Bariatric surgery · Roux-en-Y gastric bypass · Sleeve gastrectomy · Staple line leakage · Stent Bariatric surgery is the most effective long-term treatment (LSG) are the most commonly performed bariatric proce- for morbid obesity . Laparoscopic Roux-en-Y gastric dures worldwide . Staple line leakage is a severe adverse bypass (LRYGB) and laparoscopic sleeve gastrectomy event of both LRYGB and LSG with a prevalence of 1–2% [3, 4]. Revisional surgery (surgical repair of the staple line) is often necessary, although conservative management * Thomas C. C. Boerlage consisting of abscess drainage, antibiotics and nil per os in Thomas.email@example.com combination with a nasojejunal feeding tube is sometimes Department of Internal Medicine, MC Slotervaart, sufficient [5 ]. Endoscopically placed self-expandable stents Louwesweg 6, 1066 EC Amsterdam, The Netherlands can be an alternative to surgery in selected cases when there Department of Gastroenterology & Hepatology, Academic is relatively limited leakage, or when leakage persists despite Medical Center, Amsterdam, The Netherlands revisional surgery. Stent placement is effective in more than Department of Gastroenterology & Hepatology, MC 50% of these selected cases . The most frequent adverse Slotervaart, Amsterdam, The Netherlands event of stent placement in patients after bariatric surgery Department of Gastroenterology & Hepatology, Rijnstate is migration with a prevalence varying from 4.8 to 67%, ziekenhuis, Arnhem, The Netherlands depending on stent type and indication for placement [6–8]. Department of Gastroenterology & Hepatology, MC The Niti-S Beta™ stent (TaeWoong medical, South Leeuwarden, Leeuwarden, The Netherlands Korea) is an over-the-wire nitinol stent, which is specifi- Department of Surgery, MC Slotervaart, Amsterdam, cally designed for the treatment of staple line leakage after The Netherlands bariatric surgery. It has a flange at the proximal end and Department of Surgery, MC Leeuwarden, Leeuwarden, the proximal part of the stent is thickened by means of a The Netherlands Vol:.(1234567890) 1 3 Surgical Endoscopy (2018) 32:3174–3180 3175 silicone-covered double stent layer, creating a double-bump the endoscopist in discussion with the surgeon. The stent (Fig. 1). It is stated that the double-bump prevents migration was removed using an endoscopic forceps grasping the prox- by increasing the radial pressure, but there are no clinical or imal or distal retrieval string. Imaging was only repeated in experimental data supporting this. The present study was case of suspicion of persisting or recurrent leakage. designed to evaluate the success and adverse event rate of the Niti-S Beta stent. Outcome measures The primary outcome was resolution of the leakage. Res- Methods olution was defined as closure of the leak (confirmed by endoscopic visualization of the leak or radiographic imaging A retrospective study was performed in three high-volume with oral contrast) within 1 week after stent removal without bariatric centers (each > 800 bariatric interventions annu- signs of a recurrent leak after 6 weeks of follow-up and with- ally) in the Netherlands. The endoscopy database in each out need for additional surgical or endoscopic intervention. centre was searched for all consecutive patients who under- Secondary outcomes were adverse events of stent placement. went placement of a Niti-S Beta stent for staple line leak- Predefined adverse events were migration, fixation compli- age after bariatric surgery. The medical ethics committee cating removal, stenosis, bleeding, and complaints of pain certified that formal ethical review was not necessary for or dysphagia due to the stent and unresponsive to medical this study. treatment. Migration was defined as dislocation of the stent requiring an additional procedure, either endoscopic or sur- Stent procedure gical, to remove or reposition the stent. Fixation was defined as overgrowth of tissue at the stent margins hindering endo- The Niti-S Beta stent is a self-expandable fully covered scopic removal and necessitating an additional (endoscopic) double-bump metal stent with radiopaque markers at both procedure for removal. Stenosis was defined as a stricture ends. All stents were placed by endoscopists with experience requiring endoscopic dilatation. Bleeding was defined as in stent placement. The indication and timing of stent place- symptomatic gastrointestinal hemorrhage requiring a thera- ment and the type and size of the stent were at the discretion peutic intervention. of the local surgeon and endoscopist. The length of the stents ranged from 100 to 180 mm and the inner diameter from 20 Statistical analysis to 28 mm. The location and size of the leak were determined endoscopically and marked with an external radio-opaque For the primary outcome, a per-patient analysis was per- marker if preferred by the endoscopist. Next, a guidewire formed. Adverse events were analyzed per-stent and per- was placed through the scope in the duodenum or proximal patient. Data extracted included demographics, medical jejunum. The scope was removed and the delivery device (20 history and medication use, type of bariatric surgery, time to 22 Fr, length 70 cm) was introduced over the guidewire. to stent placement, concurrent interventions, stent size, dura- The stent was placed under fluoroscopic guidance and/or tion of treatment, reason for stent removal, adverse events, endoscopic guidance at the discretion of the endoscopist. and outcome. Descriptive statistics were used for all data, The stent was positioned so that the leak was in between the with mean and standard deviation (SD) in case of normal two bumps. After placement, the location was checked by distribution, and median and range for non-normal distribu- fluoroscopy and endoscopic visualization. If necessary the tion. For the main outcomes, proportions and percentages stent was relocated. The day after stent placement, an upper are shown. Several factors associated with success were gastrointestinal series or oral methylene blue test was per- hypothesized beforehand. The differences in success and formed to assess potential persisting leakage. In general, oral adverse event rate between stents placed as initial treatment intake was started after proof of the absence of significant versus stents after failed revisional surgery, first versus con- leakage. Timing of removal of the stent was determined by secutive stents, and LRYGB versus LSG, were calculated Fig. 1 The Niti-S Beta stent 1 3 3176 Surgical Endoscopy (2018) 32:3174–3180 with the Chi-square test. Potential influence of time between to resolve the leakage (group 2). This included 3 patients initial surgery and stent implantation on successful resolu- who underwent stent placement concurrently with revi- tion was checked using the Mann–Whitney U test. sional surgery which failed to control the leak. The median time between initial bariatric surgery and placement of the first stent in these cases was 14 days (range 2–735 days). Results Thirty-eight patients were included, who underwent 50 stent Outcome placements in total. The first stent was placed in October 2009. The supplier of the stent (Prion Medical BV) con- Success rate firmed that, from October 2009 to March 2016, 50 stents were provided to the participating centers. Thus, all consecu- In 25 out of 38 patients (66%), leakage was success- tive stent placements during the entire study period have fully treated with stent placement, including 14 out of 23 been included. Patient characteristics are shown in Table 1. LRYGB patients (61%) and 9 out of 13 patients with LSG Patients had a mean age of 45 and a mean BMI of 43.0 kg/ (69%, p = 0.616). One patient was lost to follow-up with m . Twenty-nine patients (76%) were female. All but 3 a stent still in place. One patient died while the stent was patients underwent percutaneous abscess drainage. in situ. Cause of death was persistent leakage in combi- nation with pre-existing decompensated liver cirrhosis. Stent placement These two stent placements were classified as unsuccess- ful. Follow-up data of at least 6 weeks after stent removal In 9 patients (24%), the initial stent was placed as primary were available for the remaining 36 patients. treatment for limited staple line leakage, a median of 20 Patients who were treated with implantation of a Beta days (range 0–152 days) after bariatric surgery (group stent as initial treatment (group 1) had a higher chance of 1). In 8 of these patients, a stent was placed after initial successful leak resolution (9 out of 9 cases, 100%) than conservative treatment was not successful. In one patient, patients who were treated with a stent after revisional staple line leakage developed during the initial bariatric surgery had failed (group 2; 16 out of 29 cases, 55%, surgery and was treated with stent placement immediately p = 0.013). Success rate was not related to the median time during surgery. In 29 cases (76%), the stent was placed between initial bariatric surgery and placement of the first as a second treatment after revisional surgery had failed Beta stent, which was 16 days in the successful group ver- sus 12 days in the unsuccessful group (p = 0.973). Table 1 Characteristics of the included patients (N = 38) Number of stents required Patient characteristics Age 45.4 (10.0) In 19 out of 38 cases (50%), one stent was sufficient, Mean (SD) including all 9 patients (100%) in group 1 and 10 out of BMI preoperative 43.0 (7.7) 29 patients (35%) in group 2. Of the remaining 19 patients Mean (SD) in group 2, 6 patients received another treatment after Weight preoperative in kilograms 125.1 (29.0) Mean (SD) the first stent failed and one patient died. In 12 patients, Sex (female) N (%) 29 (76%) the first stent was removed and a second Beta stent was Smoking N (%) 7 (18%) placed because of persistent leakage after a median of 20 Previous abdominal surgery N (%) 27 (71%) days after first stent placement. Two of these patients had Type of surgery N (%) initially been treated with a different type of stent and Primary LRYGB 12 (32%) received a Beta stent as secondary treatment. Five out of Revisional LRYGB 10 (26%) 12 patients (42%) showed resolution of the leakage after Modified LRYGB 1 (3%) the second stent. Four patients received another treatment Primary LSG 12 (32%) after the second stent failed; one patient was lost to follow- Revisional LSG 1 (3%) up, and 2 patients received a third Beta stent, which was Omega-loop Gastric Bypass 1 (3%) successful in one case (see Fig. 2). The chance of success SADI (revision after LSG) 1 (3%) of a consecutive stent did not differ from success after the first stent (6 out of 14 vs. 19 out of 36, p = 0.529). BMI Body Mass Index, LRYGB laparoscopic Roux-en-Y gastric bypass, LSG laparoscopic sleeve gastrectomy, SADI single anastomo- sis duodeno-ileal bypass 1 3 Surgical Endoscopy (2018) 32:3174–3180 3177 Fig. 2 Flowchart of stent place- ments Beta stent as primary stent N = 36 First Beta stent not First Beta stent successful successful N = 19 N = 17 Beta stent as subsequent stent aer other stent failed N = 2 Other treatment* N = 6 Beta stent as second stent Death N = 1 N = 12 Second Beta stent Second Beta stent not successful successful N = 5 N = 7 Other treatment* N = 4 Beta stent as third stent Lost to follow-up N = 1 N = 2 Third Beta stent not Third Beta stent successful successful N = 1 N = 1 * Other treatment (N = 11) included: conservave (N = 4), surgical (N = 2), Other treatment* N = 1 or other endoscopic procedures such as a diﬀerent type of stent (N = 1), over-the-scope-clipping (N = 3), or endoscopic placement of a pigtail catheter (N = 1). Other treatment after stent failure conservative treatment (n = 4) or other endoscopic inter- ventions such as a different type of stent (n = 1), over-the- In total, 11 patients had no resolution of the leakage scope-clipping (n = 3) or endoscopic placement of a pigtail catheter (n = 1). after one or multiple stent placements. These patients were successfully treated with revisional surgery (n = 2), 1 3 3178 Surgical Endoscopy (2018) 32:3174–3180 Stent removal definition of success and stent type between studies. For example, in the study describing the highest success rate Stents were left in place for a mean time of 27.7 days (SD (96%), a partially covered metal stent was placed in all 14.3). The stent was removed according to plan in 29 cases patients with staple line leakage, including small leaks that after a mean time of 36.0 days (SD 10.0). In 19 cases, the might also have closed with conservative management only stent was removed prematurely after a mean time of 15.0 . The definition of success in our study was stricter than days (SD 9.8), because of migration without options for in some other studies. Four patients who had resolution of repositioning (n = 8), complaints of dysphagia and pain the leakage more than 1 week after stent removal, but with- unresponsive to medical treatment (n = 7), persistent leak- out additional interventions, were not considered successful age (n = 3), and hemorrhage caused by the stent (n = 1). All in this study. If these patients had been defined as successful, stents were endoscopically removed without problems. as in several other studies, the success rate would have been higher (76%). Migration and other adverse events The most striking factor associated with success in this study was the difference between stents placed as initial In total, 14 patients (37%) experienced one or more adverse treatment (group 1) versus those placed after failed revi- events of stent placement. Migration occurred in 13 stents sional surgery (group 2). In group 1, the success rate was (26%) in 12 different patients (32%), including 8 out of 31 100%, compared to 55% success rate in group 2. This result stents in LRYGB patients (26%) and 3 out of 16 stents in raises the question whether immediate stent placement patients with LSG (19%, p = 0.588). In 5 cases, it was pos- should be considered in all patients with staple line leak- sible to reposition the migrated stent endoscopically. In the age . However, it must be underlined that the difference remaining 8 cases, repositioning was not possible and the between the two groups in this study is subject to consider- stent was removed. In one of these patients, the stent had able bias. Stent placement was mostly the initial treatment migrated through the leak to the retroperitoneal area and had in patients with only minor leakage. In contrast, leaks that to be removed surgically. One patient (3%) required balloon persist after revisional surgery are generally larger and more dilatation for a benign stenosis 4 months after stent removal. difficult to close. Therefore, the chance of successful stent There was one case of hemorrhage in this series, due to an treatment in these cases may be lower. aorto-esophageal fistula caused by mechanical pressure of Time between initial bariatric surgery and stent place- the stent. The patient presented with hematemesis 3 weeks ment was not a predictor of success in this study. This is after placement of a (second) Beta stent for staple line leak- in contrast to previous studies, where stent placement early age. An aorto-esophageal fistula was diagnosed at the site after surgery increased the chance of successful leak resolu- of the bump and treated with placement of an endovascular tion [10, 14]. This variation between studies is most likely covered aortic stent. This case has earlier been published as due to selection bias, with differences in indication and tim- a case report . ing of stent placement between studies. Whether early stent placement does or does not increase the success rate should be subject of further prospective research. Discussion In previous studies, placement of a consecutive stent when the first stent failed to resolve the leakage was feasi - Endoscopic placement of a self-expandable stent is an ble and had a considerable success rate . The chance of increasingly used treatment option for staple line leakage success of a consecutive stent did also not differ from the after bariatric surgery [6, 8, 10–12]. This is the first large first stent in our series. This confirms that placement of a series describing the effectiveness and adverse event rate consecutive stent should be considered when the first stent of the Niti-S Beta stent, a fully covered double-bump metal has failed to resolve the leakage. stent. The most frequent adverse event of stent placement is This study shows that staple line leakage after bariatric migration [6–8]. Despite the novel double-bump structure surgery can be effectively treated with the Beta stent in 66% of the Beta stent, which has specifically been designed to of cases. In a recently published series, with 10 patients who prevent migration, migration occurred in 32% of patients had staple line leakage after LSG, the success rate of the (26% of stents) in this study. This seems comparable to Beta stent was 80% . This success rate seems compara- the results of other fully covered stents, with a migra- ble to the results of other stents in previous studies, which tion rate of 18–67% in previous studies [8, 11, 16, 17, ranges from 62 to 96% [7, 8, 10–12, 14–19]. However, com- 19, 20]. Partially covered stents are less prone to migra- parison is hampered because all studies, including this study, tion with a migration rate of 5–15% [7, 10, 14, 15, 18]. are retrospective in nature and therefore subject to selec- However, these stents are often difficult to remove [7 ]. tion bias. In addition, there are differences in indication, Several options to prevent migration of fully covered stents 1 3 Surgical Endoscopy (2018) 32:3174–3180 3179 Open Access This article is distributed under the terms of the Creative have been described. Two studies describe fixation of the Commons Attribution 4.0 International License (http://creativecom- stent by endoscopic clipping, but only a small number of mons.org/licenses/by/4.0/), which permits unrestricted use, distribu- patients with staple line leakage was included [21, 22]. tion, and reproduction in any medium, provided you give appropriate Some authors advocate suturing of the stent to the esopha- credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. geal wall to prevent migration. However, migration rate was still 33% in one study . In this study, there was one death unrelated to the pro- References cedure and no stent-related deaths. However, there was one life-threatening adverse event: hemorrhage from an 1. Colquitt JL, Pickett K, Loveman E, Frampton GK (2014) Sur- aorto-esophageal fistula caused by mechanical pressure gery for weight loss in adults. Cochrane Database Syst Rev of the stent. 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Published: Jan 17, 2018
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