The Safety and Efficacy of Single-Operator Cholangioscopy in the Treatment of Difficult Common Bile Duct Stones after Failed Conventional ERCP

The Safety and Efficacy of Single-Operator Cholangioscopy in the Treatment of Difficult Common... Background: Common bile duct (CBD) stones are extracted with a basket or balloon during ERCP with sphincterotomy. However, some stones are difficult to extract by conventional means. Cholangioscopy with lithotripsy is a modality to treat these difficult stones. We describe the clinical efficacy of single-operator per oral cholangioscopy (SOPOC) for difficult stones and discuss cost sav - ings by avoiding surgical intervention. Methods: Retrospective chart review was performed for all patients referred for difficult CBD stones. Clinical success was defined as clearing the duct of all stones. The cost of cholangioscopy (in $CDN) was calculated by adding all costs associated with the procedure(s), surgery, hospital stay or treatment of adverse events. This cost was compared with the projected cost of surgical bile duct exploration. Results: A total of 51 patients (35 female) with a mean age of 66 years underwent 58 SOPOC proce- dures. Median procedure time was 67 minutes (95% CI, 61.5–73.5). The CBD was successfully cleared in 47 of 51 patients (93%). Minor adverse events were seen in seven patients (14%). The actual average per procedure cost was $4555±$2647. This compares with a projected cost of $7766 and $6175 for open and laparoscopic bile duct exploration, with a cost-per-case saving of $3210 and $1619, respectively. Conclusion: SOPOC with lithotripsy is highly effective and safe for the treatment of difficult common bile duct stones. In addition, significant cost savings may be realized by avoiding surgical bile duct exploration. Keywords: Cholangioscopy, Cost-comparison, Lithotripsy, Stones SOPOC, single-operator per oral cholangioscopy; Abbreviations: UAH, University of Alberta Hospital; CBD, common bile duct; GA, general anesthesia; ERCP, endoscopic retrograde DS, Digital SpyGlass; cholangiopancreatography; Fr, French; $CDN, Canadian dollars; LOS, Length of stay; OCBDE, open CBD exploration; AHS, Alberta Health Services; LCBDE, laparoscopic CBD exploration; ESWL, Extra-corporeal shock-wave lithotripsy POC, per oral cholangioscopy; EHL, electrohydraulic lithotripsy; © The Author(s) 2018. Published by Oxford University Press on behalf of the Canadian Association of Gastroenterology. 1 This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com Downloaded from https://academic.oup.com/jcag/advance-article-abstract/doi/10.1093/jcag/gwy021/4994575 by Ed 'DeepDyve' Gillespie user on 07 June 2018 2 Journal of the Canadian Association of Gastroenterology, 2018, Vol. XX, No. XX referred for difficult CBD stones for which conventional ERCP INTRODUCTION was unsuccessful. The goal of treatment was to clear the CBD of Common bile duct (CBD) stones occur in approximately 10%– the indicated stone(s). 15% of patients with cholelithiasis (1). Conventional treatment All patients referred for SOPOC had at least one previous for CBD stones currently entails endoscopic retrograde cholan- ERCP, during which conventional methods to extract the giopancreatography (ERCP) with sphincterotomy and extraction stone(s) failed. Most of these cases were referred by high-vol- of stones with a balloon catheter or basket (2). The most cost-ef - ume endoscopists performing >75 ERCPs/year. Whenever fective management of these stones in patients undergoing chole- possible, cases (procedure note and fluoroscopy images) were cystectomy appears to be peri-operative ERCP (3). However, in reviewed before performing SOPOC. If the stone(s) fit the 10%–15% of patients with CBD stones, the stones are not amena- definition of a ‘difficult’ stone, as per our criteria, and if con- ble to conventional ERCP, including additional intervention such ventional methods of stone extraction (including mechani- as balloon sphincteroplasty and mechanical basket lithotripsy cal basket lithotripsy and dilation-assisted stone extraction) (4–8). Such ‘difficult’ CBD stones are large, multiple-stacked and had been employed previously and failed, then we chose to faceted (square-shaped) and include those that are impacted in proceed directly to SOPOC. All SOPOC procedures, done the CBD, or located proximal to a stricture (Figure 1). With failed as outpatient day procedures, were planned electively and conventional ERCP, the accepted choice of treatment for these scheduled with general anesthesia (GA). However, if GA was stones would be open CBD exploration (OCBDE) or laparo- unavailable, endoscopist-administered conscious sedation scopic CBD exploration (LCBDE). Furthermore, patients with was performed. prior cholecystectomy who present with CBD stones would need SOPOC procedures were initially performed with the orig- to undergo surgery exclusively for the CBDE. Per oral cholangios- inal SpyGlass Legacy single-operator direct visualization sys- copy (POC) and electrohydraulic lithotripsy (EHL) provide an tem (Boston Scientific Corporation, Marlborough, MA, USA). alternative treatment for such patients to avoid surgical manage- However, a switch was made to the newer Digital SpyGlass ment of these difficult CBD stones pre- or post-cholecystectomy (DS) system (Boston Scientific Corporation, Marlborough, (9–11). To date, no studies have assessed the cost-efficacy associ - MA, USA) when it became commercially available. ated with treatment of difficult CBD stones with POC. Herein, we evaluate the clinical impact of single-operator POC (SOPOC) on Procedure the treatment of difficult CBD stones, as well as assess the cost of Ae ft r the removal of a previously placed biliary stent, cannula - SOPOC compared with surgical bile duct exploration. tion of the CBD with the SOPOC probe was performed with or without the use of a guidewire. Our protocol is for initi- METHODS ating direct cholangioscopy without injecting radiographic contrast, as we believe that the density of the contrast dye We performed a retrospective chart review of SOPOC pro- may impede optimal cholangioscopic visualization. This was cedures done at the University of Alberta Hospital (UAH) Figure  1. ‘Difficult’ common bile duct (CBD) stones. A, single, large, faceted stone (white arrow) proximal to a CBD stricture (black arrow). B, multiple, stacked stones (arrows). C, stone impacted in CBD (arrow). Downloaded from https://academic.oup.com/jcag/advance-article-abstract/doi/10.1093/jcag/gwy021/4994575 by Ed 'DeepDyve' Gillespie user on 07 June 2018 Journal of the Canadian Association of Gastroenterology, 2018, Vol. XX, No. XX 3 particularly true for the Legacy system, but with the enhanced the EHL probes, and the cost of equipment based on actual and improved visualization with the DS system, this is less of usage of extraction/assisting devices (snare, guidewire, bal- a concern. Our preferred solution for irrigation in the CBD loon extraction catheter, balloon dilator, extraction basket, is 0.9% normal saline, as it also aids in conducting the electri- rat-tooth forceps, stent retriever, etc.). Anesthesia or sedation cal impulse required for EHL. Once the stone was visualized, and reimbursement of all personnel involved in the procedure, EHL was performed using the Autolith EHL generator and a including the gastroenterologist, nursing staff, technical sta ff 1.9 French (Fr) EHL probe (Nortech, Northgate Technologies, and anesthesiologist—if present—were also added to the total Elgin, IL, USA). An initial power setting of 50 watts and a fre- cost (Table 1). Costs associated with any adverse event, subse- quency of five pulses per second were used, but depending upon quent surgery or hospital stay arising from the procedure were the impact on the stone, these parameters were changed during also included in this cost analysis. The upfront capital cost to the procedure. The number of EHL applications was purely at purchase the SOPOC system was not included in the cost anal- the discretion of the endoscopist based on visual fissuring and ysis. Similarly, we did not include capital cost for the purchase fragmentation of the stone. W hen the stone was optimally frag- of surgical instruments. mented, the SOPOC system was removed, and then conven- The average actual cost of SOPOC was compared with the tional means of stone extraction by standard ERCP were used calculated costs of surgical alternatives, such as OCBDE and to clear the CBD of all fragments. A stent was only replaced if LCBDE. This projected surgical cost included reimbursement duct clearance could not be guaranteed and a repeat procedure of the surgeon, anesthesiologist, nursing and technical staff, and was being contemplated. Repeat ERCP with or without chol- the cost related to the postoperative length of stay (LOS) in angioscopy was performed as necessary and at the discretion hospital (Table 2). The average LOS was extracted from expert of the endoscopist. Clinical success was defined as complete opinion from our local surgeons and from published data from clearance of the CBD (Figure  2) as evidenced by cholangiog- the provincial Alberta Health Services (AHS) database. For raphy done during the index procedure or on any subsequent the purposes of this study, the accepted LOS was two days for procedure done to extract any remaining fragments. LCBDE and four days for OCBDE. Published literature, how- The average cost per case of extracting a difficult CBD ever, has LOS data (average LOS for LCBDE 4.2 days and for stone (or stones) was calculated by adding the cumula- OCBDE 12.6 days) that does not reflect the current pae tt rn of tive costs of all ERCPs conducted following the initial failed practice at our hospital (12). We chose not to include the addi- ERCP. This included the index SOPOC and any subsequent tional cost of a cholecystectomy (for those patients that had ERCPs with or without cholangioscopy until the CBD was concomitant cholelithiasis), as our intent is simply to compare clear. These include the cost of the SOPOC (Legacy or DS), the costs associated with therapeutic intervention for difficult Figure 2. ERCP images of the common bile duct before (A) and ae ft r (B) extraction of multiple stacked stones with complete clearance of CBD. Downloaded from https://academic.oup.com/jcag/advance-article-abstract/doi/10.1093/jcag/gwy021/4994575 by Ed 'DeepDyve' Gillespie user on 07 June 2018 4 Journal of the Canadian Association of Gastroenterology, 2018, Vol. XX, No. XX Table 1. Cost, in $CDN, of ERCP (with SpyGlass+EHL) CBD stones. All costs were calculated based on the current Alberta Health Services reimbursement schedule. Diagnostic imaging component Radiology tech time, benefits, and clerical costs 55.56 STATISTICS Radiographic film (digital) and contrast 81.84 Fluoroscopy equipment service package (per 31.25 Descriptive statistics were used for continuous variables using case) ($25,000 per year/800 ERCPs) mean or median, as appropriate, along with their corresponding Radiologist reimbursement fee 29.03 95% confidence intervals. Gastroenterology Component Nursing salary and benefits RESULTS (RN for procedure room and LPN for recovery room) Patient Characteristics RN 60.25 Between April 2011 and June 2015, 51 patients were referred to LPN 39.94 the UAH for SOPOC for difficult CBD stones ( Table 3). There Medications (unit price) were 35 females (69%), and the mean age was 66 years (range Midazolam (per mg) 1.25 30–88 years). Referrals were from received from other tertiary Fentanyl (per 100 μg) 0.44 care hospitals in adjacent provinces (3 of 51 patients, 6%), local Diazemuls (per 5 mg) 1.15 and regional community hospitals (13 of 51 patients, 25%) and Medical and surgical supplies (including gloves, 80.00 from other endoscopists at our own hospital (35 of 51 patients, IV tubing, O2 tubing etc.), scope disinfection and 69%). Difficult CBD stones ( Figure  1) were defined as those laundry that were single-large (26 of 51), multiple-large and stacked (15 Endoscopy equipment service package (service 12.00 of 51), faceted (one of 51), impacted (seven of 51) or located contract with vendor per ERCP) proximal to a stricture in the CBD (eight of 51). There was over - SpyGlass cost/case (Legacy and DS) lap of categories in seven patients. Legacy ($950+$375) 1325.00 A total of 58 ERCPs with SOPOC were performed in these DS (based on purchase of a pack of 10 probes) 1695.00 51 patients by a single endoscopist (GS). All ERCPs were per- EHL probe (single use) 395.00 formed using the Olympus TJ180 side-viewing duodenoscope SpyBite forceps 595.00 (Olympus America, Melville, NY USA). Of these 58 SOPOC Sphincterotome 275.00 Balloon extraction catheter 140.00 procedures, 49 were performed with the original SpyGlass Locking device 90.00 Legacy system and nine with the SpyGlass Digital system that Snare 11.00 was acquired in April 2015 (Figure  3). The median time per Extraction basket 270.00 procedure was 67 ± 6.5 minutes (95% confidence interval, 61.5– Balloon dilator 150.00 73.5), calculated from 56 of the 58 procedures for which proce- Guide wire 100.00 dure time was noted. The range of time for the whole cohort was Stent—Plastic 145.00 24–124 minutes. The total time per procedure includes not only Stent—Metal 1300.00 the time spent on SOPOC and EHL but also the time spent on Soehendra stent retriever 199.00 extracting the stone fragments. Forty-eight of these procedures Rat-tooth forceps 171.00 were done under general anesthesia (with an ae tt ndant anesthesi - Gastroenterologist reimbursement fees ologist), and 10 were done with topical xylocaine anesthesia and ERCP 262.18 conscious sedation using midazolam and fentanyl (administered Cholangioscopy 164.85 and monitored by the nurse and endoscopist). Electrohydraulic lithotripsy 113.99 Twenty-seven patients previously underwent cholecystec- Stone extraction 57.00 tomy (Table  3). Two had a cholecystectomy ae ft r a successful Anesthesia Component removal of CBD stones by SOPOC, one underwent cholecys- Anesthesia machine service package 27.00 tectomy with CBDE ae ft r a failed SOPOC, and one had an Anesthesia cost/case for GA (cost of gases, 100.00 open CBDE ae ft r a failed SOPOC. One patient with a prior tubing, ECG leads etc.) cholecystectomy also had undergone a failed CBDE prior to Anesthesia tech time and benefits ($50/hr) 50.00 referral for SOPOC. Anesthesiologist reimbursement 217.20 A total of 108 ERCPs were performed before referral for ($18.10 per 5 min) SOPOC. Twenty-three patients had one ERCP, 19 patients had Inpatient component two ERCPs, four patients had three ERCPs, one patient had 4, Cost of medical ward/day 973.00 one patient had 6, while one patient had 25 ERCPs (for routine Downloaded from https://academic.oup.com/jcag/advance-article-abstract/doi/10.1093/jcag/gwy021/4994575 by Ed 'DeepDyve' Gillespie user on 07 June 2018 Journal of the Canadian Association of Gastroenterology, 2018, Vol. XX, No. XX 5 Table 2. Cost, in $CDN, of CBD exploration ($CDN) Diagnostic imaging component OCBDE LCBDE (For intra-operative cholangiogram) Radiology tech time, benefits, and clerical costs 55.56 55.56 Radiographic film (digital) and contrast 81.84 81.84 Fluoroscopy equipment service package (per case) 31.25 31.25 Radiologist reimbursement fee 29.03 29.03 Surgery Component Nursing salary and benefits (2–3 nurses for the procedure including recovery room) 836.00 762.00 Medical and surgical supplies (including surgical kit, gloves, IV tubing, O2 tubing etc.), sterilization 620.00 1280.00 and laundry Biliary Fogarty catheters (3–5 Fr) 39.24 39.24 Specimen collection bag 180.00 180.00 Guide wire 42.00 42.00 8 mm balloon dilator 140.00 140.00 Choledochoscope cost per case (with light source/monitor etc., service contact with vendor) 12.00 12.00 Loop ligatures 6.41 6.41 T-tube 15.00 15.00 Surgeon reimbursement fee 1024.28 1024.28 Hospital LOS 4 days 2 days Anesthesia Component Anesthesia machine service package 27.00 27.00 Anesthesia cost/case for GA (cost of gases, tubing, ECG leads etc.) 100.00 100.00 Anesthesia tech time and benefits ($50/hr) 91.66 75.00 Anesthesiologist reimbursement ($18.10 per 5 min) 398.20 325.80 Inpatient component Cost of ICU/day 3296.00 3296.00 Cost of surgical ward/day 1044.00 1044.00 plastic stent replacement every three months over the previ- patients, the CBD stones were above a stricture and not of a size ous five years) before SOPOC. This last patient was found to for which EHL was necessary (the strictures were deemed to be have a 4  cm CBD stone that was not amenable to endoscopic the more clinically relevant and significant pathology); in the extraction, and she was deemed not to be a surgical candi- remaining two patients, stones were deemed to be of a size small date by her local surgeon. One patient was referred directly for enough that they were extracted without the need for EHL. SOPOC without a prior ERCP. On an intention-to-treat basis (i.e., with the intent of refer- ral for SOPOC being clearance of the duct), SOPOC was Clinical Success successful in clearing the CBD in 47 of 51 patients (overall effi - All patients referred for SOPOC underwent cholangioscopy cacy 93%). The presence of a CBD stricture precluded stone prior to cholangiography. Of the 58 SOPOC procedures, EHL extraction in two patients (one with primary sclerosing cholan- was performed in 52 procedures by utilizing 53 probes (one gitis and one with a benign stone-induced stricture), and the patient required a second EHL probe ae ft r the first one had stones were of a size that did not warrant EHL. One patient had burnt out, presumably because of prolonged use). Successful a large stone impacted at the cystic duct confluence with the fragmentation of stone(s) and extraction with duct clearance CBD and could not be fragmented by EHL. This patient under - were possible in 50 of 52 procedures where EHL was used went OCBDE and was found to have Mirizzi’s syndrome and (overall therapeutic efficacy of EHL: 96%) for difficult CBD required repair of the cholecyst-choledochal fistula. Another stones. The actual number of pulses fired was not calculated, patient had a 4–5  cm stone concretion around a metal stent and the duration of EHL was purely based on the discretion of placed five years previously for a benign CBD stricture. EHL the endoscopist based on visual evidence of fracturing and frag- was unsuccessful, and a second, longer metal stent was placed mentation. EHL was not used in six procedures: in two patients, for drainage. there were no stones visible in the CBD on cholangioscopy, and In eight patients, an additional 14 ERCPs were performed cholangiography revealed a clear duct as well; in another two ae ft r SOPOC. Two of these patients had a total of seven ERCPs, Downloaded from https://academic.oup.com/jcag/advance-article-abstract/doi/10.1093/jcag/gwy021/4994575 by Ed 'DeepDyve' Gillespie user on 07 June 2018 6 Journal of the Canadian Association of Gastroenterology, 2018, Vol. XX, No. XX Figure 3. SpyGlass Legacy images (A and B) and SpyGlass DS images (C and D) before and ae ft r fragmentation of stone. but the indication for these subsequent procedures was a CBD post-ERCP pancreatitis despite a previous sphincterotomy, and stricture rather than the stone. Therefore, the cost of these extra this resulted in a four-day hospital stay. procedures was not factored into the overall cost of SOPOC. Cost Comparison In the remaining six patients, seven ERCPs were required to clear the CBD of remnant fragments of stone. The cost associ - The average cost of SOPOC was $4555±$2647 (range $2538– ated with these procedures was included in the overall cost of $14,923). We calculated the cost of OCBDE and LCBDE to SOPOC. be $7766 and $6175, respectively. The cost saved per patient by performing SOPOC compared with OCBDE and LCBDE Adverse Events was $3211 and $1620, respectively. The rate of adverse events A total of seven patients (14%) suffered minor adverse events for CBDE as extracted from published data is 3.2%. The total from SOPOC. Four patients suffered mild bleeding from the treatment cost of the most common surgical adverse events was CBD as a result of contact trauma from EHL (Figure 4). All of calculated to be $4977 for a bile leak, $5216 for an intra-abdom- these were self-resolving, as observed during direct cholangios- inal hemorrhage, and $3701 for an intra-abdominal abscess. copy, and did not require any further intervention. One patient These costs have not been added to the cost of OCBDE and was noticed to have a tear at the gastroesophageal junction. We LCBDE listed above. feel this occurred as a result of snare extraction of an 11.5 Fr stent. Ae ft r the ERCP was completed, this tear was repaired DISCUSSION with eight clips placed with a gastroscope, and the patient did Difficult CBD stones can present technical challenges to ae tt mpts well. One patient with stone fragments in the cystic duct stump at removal during ERCP. These stones are large (single or multi - with a prior cholecystectomy incurred a cystic duct stump ple and stacked), faceted (square-shaped), impacted or situated leak caused by the guidewire used for the stone extraction. proximal to a stricture, and thus not amenable to conventional A plastic stent was inserted during the Spyglass ERCP and was modalities of treatment such as balloon extraction or engagement removed in a subsequent ERCP. One patient developed acute Downloaded from https://academic.oup.com/jcag/advance-article-abstract/doi/10.1093/jcag/gwy021/4994575 by Ed 'DeepDyve' Gillespie user on 07 June 2018 Journal of the Canadian Association of Gastroenterology, 2018, Vol. XX, No. XX 7 Table 3. Patient characteristics Patients (n) 51 Age in years, mean (range) 66 (30–88) Gender (F) 35 Indication for SOPOC/EHL (n) Single large stone 26 Multiple stacked stones 15 Faceted stone 1 Impacted stone 7 Stone proximal to stricture 8 Prior cholecystectomy (n) 27 Prior ERCPs (n) 108 SOPOCs (n) 58 SOPOC procedure time (minutes), 67 (61.5, 73.5) median (95% CI) (range) (24–124) Adverse events secondary to 87 SOPOC/EHL Spontaneously-resolving 4 EHL -induced CBD trauma Figure  4. Mild trauma (black arrow) to the common bile duct from electrohydraulic litho- GE junction tear (plastic 1 tripsy probe (white arrow). stent-induced) Wire-induced CD stump leak 1 within the CBD. The original SpyGlass Legacy system has Post-ERCP pancreatitis 1 recently been upgraded to the Digital SpyGlass system with Subsequent procedures significant improvements, such as enhanced optical resolution, ERCP 14 wider field of view and bee tt r operator handling. Using the Cholecystectomy 2 SOPOC system in our referral institution, we achieved a tech- OCBDE 1 nical success rate of 96%, with fragmentation of difficult CBD LC-OC+CBDE 1 stones with EHL and a duct clearance rate of 93% on an inten- tion-to-treat basis. These results are in keeping with a recent GE, gastro-esophageal; CD, cystic duct; LC-OC, laparoscopic meta-analysis of 31 studies showing a technical success rate cholecystectomy converted to open cholecystectomy. of 91% and stone clearance in 88% (15). However, there have been no studies comparing the cost of cholangioscopy with within a retrieval basket. Additional interventions such as conventional alternatives such as surgical bile duct exploration. mechanical lithotripsy and balloon sphincteroplasty may also not Adverse events seen in our study were higher than that be helpful because of size, shape or impaction of the stone(s). reported with CBDE (14% versus 3.2%), but they were all The options for removal of such difficult CBD stones are minor and self-resolving, except one patient requiring a four- extra-corporeal shock-wave lithotripsy (ESWL), cholangios- day hospitalization for mild post-ERCP pancreatitis. Adverse copy with intra-ductal lithotripsy (with EHL or laser) and events associated with surgery (e.g., bile leak, intra-abdominal CBDE. In a comparative study, POC with laser lithotripsy was hemorrhage, or intra-abdominal abscess) are more severe and found to be more effective and safer than ESWL for fragmen- have a greater impact on patient quality of life and longer hospi- tation of CBD stones (97% versus 73%, respectively) (13). tal LOS, which further adds to health care resource utilization. Furthermore, ESWL requires subsequent ERCP for removal In the Canadian health care system, the upfront capital cost of fragmented stones. POC using mother-baby cholangioscopy of investing in a SOPOC system, such as the SpyGlass system, with EHL reported stone clearance in 90% of patients (14). The is a significant deterrent to the acquisition of such technol - authors recommend the use of POC as the first line treatment ogy. However, our study shows that even in the small subset for difficult stones before using other modalities. However, of patients with difficult CBD stones who pose a significant because of the fragility of the baby endoscope, mother-baby medical challenge, the procedure is very effective and has an cholangioscopy has fallen out of favour amongst most biliary excellent safety profile. We believe this justifies the adoption of endoscopists. SOPOC in a limited number of specialized centers so that the With the introduction of the SOPOC system, there has been technology is available for direct patient care. In addition, the renewed interest in the diagnostic and therapeutic abilities significant cost savings realized by avoiding alternative methods Downloaded from https://academic.oup.com/jcag/advance-article-abstract/doi/10.1093/jcag/gwy021/4994575 by Ed 'DeepDyve' Gillespie user on 07 June 2018 8 Journal of the Canadian Association of Gastroenterology, 2018, Vol. XX, No. XX of intervention—especially surgery (LCBDE and OCBDE— LCBDE and pre- or post-cholecystectomy ERCP. However, show that the technology is cost effective. they do not address the specific question of difficult CBD Our study analyzed the actual costs of SOPOC for difficult stones but instead deal with the issue of CBD stones when a CBD stones compared with the alternative of surgical inter- cholecystectomy also needs to be done. In our cohort of 51 vention. Most of the studies comparing endoscopic with surgi- patients, 27 patients (53%) already had a previous cholecys- cal management of CBD stones address the issue in the context tectomy and would have had to undergo another surgical pro- of cholecystectomy. A  recent Cochrane review suggested the cedure in the event of failure of endoscopic treatment of these superiority of OCBDE over ERCP in managing CBD stones difficult CBD stones. based on data from early endoscopic studies (2). They found It is also important to note that our patient cohort had previ- no differences in the clinical efficacy or outcomes comparing ously undergone an average of more than two ERCP procedures Figure 5. Proposed algorithm for management of common bile duct (CBD) stones. ERCP, Endoscopic retrograde cholangiopancreatography; CBD, Common bile duct; DASE, Dilation-assisted stone extraction; SOPOC, Single-operator per oral cholangioscopy; EHL, electrohydraulic lithotripsy; LCBDE, laparoscopic common bile duct exploration; OCBDE, open common bile duct exploration. Downloaded from https://academic.oup.com/jcag/advance-article-abstract/doi/10.1093/jcag/gwy021/4994575 by Ed 'DeepDyve' Gillespie user on 07 June 2018 Journal of the Canadian Association of Gastroenterology, 2018, Vol. XX, No. XX 9 before being referred for SOPOC for difficult stones. We believe cost-per-case savings compared with surgical management offsets that further cost savings can be realized with the appropriate and the upfront capital cost and ongoing operational costs required timely identification of difficult CBD stones. Based on our experi - for SOPOC and EHL. We recommend that SOPOC with EHL ence, we propose an algorithmic approach to the management of be adopted as the standard of care for treatment of difficult CBD these difficult CBD stones ( Figure  5). Patients with CBD stones stones ae ft r failure of conventional ERCP before CBDE. should undergo routine ERCP with conventional methods of stone removal such as sphincterotomy followed by balloon or ACKNOWLEDGMENTS basket extraction. If unsuccessful, advanced interventions such The authors wish to acknowledge the assistance of Ralph Ennis-Davis as mechanical lithotripsy and balloon sphincteroplasty should be (Endoscopy Unit Manager, University of Alberta Hospital) and Dr. performed during the index ERCP. If the endoscopist is not com- Michael Murphy, Dr. Barry Finegan (Department of Anesthesiology, fortable with these techniques, the patient should be referred to a University of Alberta Hospital) and Dr. Ronald Brisebois (Department tertiary care facility. Failure of these advanced interventions defines of Surgery, University of Alberta Hospital) for their assistance in pro- difficult CBD stones and the patient should be referred for SOPOC viding data information for this manuscript. Ethics approval was for further management. Streamlining and minimizing unneces- obtained from the Ethics Review Board of the University of Alberta sary procedures can realize further healthcare resource savings. (Study # Pro00057683). Author contributions: JS and GS acquired, We recognize that anesthesia services are not readily available analyzed and interpreted data. JS wrote the manuscript. JS, SVVZ and at many centres. GA definitely allowed for a very comfortable GS revised the manuscript and gave final approval. procedure, not only for the patient but for the endoscopist as Conflicts of Interest well, because these procedures can be fairly lengthy and labori- Dr. Gurpal Sandha is a consultant and member of the biliary medical ous. Also, since a significant amount of saline is required for irri - advisory board for Boston Scientific Corporation and has received honoraria for speaking and proctoring. Jaskiran Sandha and Dr. gation, and because some of this fluid can sequester in the fundus Sander Veldhuyzen van Zanten have no conflicts of interest relevant of the stomach with patients being in the left lateral position, to this study. endotracheal intubation ensured airway protection. Because the average procedure time for our cohort was slightly over an hour, GA was felt to be more beneficial than conscious sedation, References especially in the extremely time-consuming cases. Other than the ease of performing procedures under GA, we do not feel 1. Soltan HM, Kow L, Toouli J. A simple scoring system for predicting that GA had any impact on the high rate of success. Procedures bile duct stones in patients with cholelithiasis. J Gastrointest Surg. can be performed equally effectively provided patients are well 2001;5(4):434–7. 2. Dasari BV, Tan CJ, Gurusamy KS, et  al. Surgical versus endo- sedated with conscious sedation. However, if this is not possible, scopic treatment of bile duct stones. Cochrane Database Syst Rev we highly recommend repeating the procedure with GA. 2013;12:CD003327. There are several limitations of our study. First, this is a sin- 3. Brown LM, Rogers SJ, Cello JP, et  al. Cost-effective treatment of gle-centre, single-operator experience that brings into question patients with symptomatic cholelithiasis and possible common the generalizability of the results. However, the authors believe bile duct stones. J Am Coll Surg 2011;212(6):1049–60.e1–7. that similar results are achievable when procedures are done in a 4. Binmoeller KF, Schafer TW. Endoscopic management of bile duct high-volume facility. Furthermore, most of the cases described stones. J Clin Gastroenterol 2001;32(2):106–18. were performed with the original SpyGlass Legacy system. The 5. McHenry L, Lehman G. Difficult bile duct stones. Curr Treat new Digital SpyGlass platform is significantly improved and Options Gastroenterol 2006;9(2):123–32. makes it easier to achieve operator performance. Secondly, this 6. Neuhaus H. Endoscopic and percutaneous treatment of difficult is a retrospective observational study and does not address the bile duct stones. Endoscopy 2003;35(8):S31–4. comparison of efficacy and costs in a randomized, prospective 7. van der Velden JJ, Berger MY, Bonjer HJ, et al. Percutaneous treat- ment of bile duct stones in patients treated unsuccessfully with manner. Moreover, because this is a comparison of actual costs endoscopic retrograde procedures. Gastrointest Endosc 2000;51(4 of SOPOC versus calculated estimates of CBDE, we may have Pt 1):418–22. underestimated the true cost of surgical intervention, which 8. Yasuda I, Itoi T. Recent advances in endoscopic management of dif- may be greater due to adverse events not mentioned in this ficult bile duct stones. Dig Endosc 2013;25(4):376–85. report and the associated increase in hospital LOS. So, in real- 9. Trikudanathan G, Arain MA, Aatt m R, et  al. Advances in the ity, the true difference in cost between SOPOC and CBDE may endoscopic management of common bile duct stones. Nat Rev actually be greater than we have described. Gastroenterol Hepatol 2014;11(9):535–44. In summary, SOPOC with EHL, done on an outpatient basis, 10. Alameel T, Bain V, Sandha G. Clinical application of a single-oper- is a highly effective treatment modality for difficult CBD stones ator direct visualization system improves the diagnostic and ther- and offers a less invasive approach compared with conventional apeutic yield of endoscopic retrograde cholangiopancreatography. surgical management by CBDE. Our study demonstrates that the Can J Gastroenterol 2013;27(1):15–9. Downloaded from https://academic.oup.com/jcag/advance-article-abstract/doi/10.1093/jcag/gwy021/4994575 by Ed 'DeepDyve' Gillespie user on 07 June 2018 10 Journal of the Canadian Association of Gastroenterology, 2018, Vol. XX, No. XX 11. Chen YK, Parsi MA, Binmoeller KF, et  al. Single-operator chol- lithotripsy for difficult bile duct stones. Gastrointest Endosc angioscopy in patients requiring evaluation of bile duct disease 1998;47(5):327–34. or therapy of biliary stones (with videos). Gastrointest Endosc 14. Arya N, Nelles SE, Haber GB, et  al. Electrohydraulic lithotripsy 2011;74(4):805–14. in 111 patients: A  safe and effective therapy for difficult bile duct 12. Grubnik VV, Tkachenko AI, Ilyashenko VV, et  al. Laparoscopic stones. Am J Gastroenterol 2004;99(12):2330–4. common bile duct exploration versus open surgery: Comparative 15. Korrapati P, Ciolino J, Wani S, et  al. The efficacy of peroral chol - prospective randomized trial. Surg Endosc 2012;26(8):2165–71. angioscopy for difficult bile duct stones and indeterminate stric - 13. Neuhaus H, Zillinger C, Born P, et  al. Randomized study of tures: A  systematic review and meta-analysis. Endosc Int Open intracorporeal laser lithotripsy versus extracorporeal shock-wave 2016;4(3):E263–75. Downloaded from https://academic.oup.com/jcag/advance-article-abstract/doi/10.1093/jcag/gwy021/4994575 by Ed 'DeepDyve' Gillespie user on 07 June 2018 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of the Canadian Association of Gastroenterology Oxford University Press

The Safety and Efficacy of Single-Operator Cholangioscopy in the Treatment of Difficult Common Bile Duct Stones after Failed Conventional ERCP

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Abstract

Background: Common bile duct (CBD) stones are extracted with a basket or balloon during ERCP with sphincterotomy. However, some stones are difficult to extract by conventional means. Cholangioscopy with lithotripsy is a modality to treat these difficult stones. We describe the clinical efficacy of single-operator per oral cholangioscopy (SOPOC) for difficult stones and discuss cost sav - ings by avoiding surgical intervention. Methods: Retrospective chart review was performed for all patients referred for difficult CBD stones. Clinical success was defined as clearing the duct of all stones. The cost of cholangioscopy (in $CDN) was calculated by adding all costs associated with the procedure(s), surgery, hospital stay or treatment of adverse events. This cost was compared with the projected cost of surgical bile duct exploration. Results: A total of 51 patients (35 female) with a mean age of 66 years underwent 58 SOPOC proce- dures. Median procedure time was 67 minutes (95% CI, 61.5–73.5). The CBD was successfully cleared in 47 of 51 patients (93%). Minor adverse events were seen in seven patients (14%). The actual average per procedure cost was $4555±$2647. This compares with a projected cost of $7766 and $6175 for open and laparoscopic bile duct exploration, with a cost-per-case saving of $3210 and $1619, respectively. Conclusion: SOPOC with lithotripsy is highly effective and safe for the treatment of difficult common bile duct stones. In addition, significant cost savings may be realized by avoiding surgical bile duct exploration. Keywords: Cholangioscopy, Cost-comparison, Lithotripsy, Stones SOPOC, single-operator per oral cholangioscopy; Abbreviations: UAH, University of Alberta Hospital; CBD, common bile duct; GA, general anesthesia; ERCP, endoscopic retrograde DS, Digital SpyGlass; cholangiopancreatography; Fr, French; $CDN, Canadian dollars; LOS, Length of stay; OCBDE, open CBD exploration; AHS, Alberta Health Services; LCBDE, laparoscopic CBD exploration; ESWL, Extra-corporeal shock-wave lithotripsy POC, per oral cholangioscopy; EHL, electrohydraulic lithotripsy; © The Author(s) 2018. Published by Oxford University Press on behalf of the Canadian Association of Gastroenterology. 1 This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com Downloaded from https://academic.oup.com/jcag/advance-article-abstract/doi/10.1093/jcag/gwy021/4994575 by Ed 'DeepDyve' Gillespie user on 07 June 2018 2 Journal of the Canadian Association of Gastroenterology, 2018, Vol. XX, No. XX referred for difficult CBD stones for which conventional ERCP INTRODUCTION was unsuccessful. The goal of treatment was to clear the CBD of Common bile duct (CBD) stones occur in approximately 10%– the indicated stone(s). 15% of patients with cholelithiasis (1). Conventional treatment All patients referred for SOPOC had at least one previous for CBD stones currently entails endoscopic retrograde cholan- ERCP, during which conventional methods to extract the giopancreatography (ERCP) with sphincterotomy and extraction stone(s) failed. Most of these cases were referred by high-vol- of stones with a balloon catheter or basket (2). The most cost-ef - ume endoscopists performing >75 ERCPs/year. Whenever fective management of these stones in patients undergoing chole- possible, cases (procedure note and fluoroscopy images) were cystectomy appears to be peri-operative ERCP (3). However, in reviewed before performing SOPOC. If the stone(s) fit the 10%–15% of patients with CBD stones, the stones are not amena- definition of a ‘difficult’ stone, as per our criteria, and if con- ble to conventional ERCP, including additional intervention such ventional methods of stone extraction (including mechani- as balloon sphincteroplasty and mechanical basket lithotripsy cal basket lithotripsy and dilation-assisted stone extraction) (4–8). Such ‘difficult’ CBD stones are large, multiple-stacked and had been employed previously and failed, then we chose to faceted (square-shaped) and include those that are impacted in proceed directly to SOPOC. All SOPOC procedures, done the CBD, or located proximal to a stricture (Figure 1). With failed as outpatient day procedures, were planned electively and conventional ERCP, the accepted choice of treatment for these scheduled with general anesthesia (GA). However, if GA was stones would be open CBD exploration (OCBDE) or laparo- unavailable, endoscopist-administered conscious sedation scopic CBD exploration (LCBDE). Furthermore, patients with was performed. prior cholecystectomy who present with CBD stones would need SOPOC procedures were initially performed with the orig- to undergo surgery exclusively for the CBDE. Per oral cholangios- inal SpyGlass Legacy single-operator direct visualization sys- copy (POC) and electrohydraulic lithotripsy (EHL) provide an tem (Boston Scientific Corporation, Marlborough, MA, USA). alternative treatment for such patients to avoid surgical manage- However, a switch was made to the newer Digital SpyGlass ment of these difficult CBD stones pre- or post-cholecystectomy (DS) system (Boston Scientific Corporation, Marlborough, (9–11). To date, no studies have assessed the cost-efficacy associ - MA, USA) when it became commercially available. ated with treatment of difficult CBD stones with POC. Herein, we evaluate the clinical impact of single-operator POC (SOPOC) on Procedure the treatment of difficult CBD stones, as well as assess the cost of Ae ft r the removal of a previously placed biliary stent, cannula - SOPOC compared with surgical bile duct exploration. tion of the CBD with the SOPOC probe was performed with or without the use of a guidewire. Our protocol is for initi- METHODS ating direct cholangioscopy without injecting radiographic contrast, as we believe that the density of the contrast dye We performed a retrospective chart review of SOPOC pro- may impede optimal cholangioscopic visualization. This was cedures done at the University of Alberta Hospital (UAH) Figure  1. ‘Difficult’ common bile duct (CBD) stones. A, single, large, faceted stone (white arrow) proximal to a CBD stricture (black arrow). B, multiple, stacked stones (arrows). C, stone impacted in CBD (arrow). Downloaded from https://academic.oup.com/jcag/advance-article-abstract/doi/10.1093/jcag/gwy021/4994575 by Ed 'DeepDyve' Gillespie user on 07 June 2018 Journal of the Canadian Association of Gastroenterology, 2018, Vol. XX, No. XX 3 particularly true for the Legacy system, but with the enhanced the EHL probes, and the cost of equipment based on actual and improved visualization with the DS system, this is less of usage of extraction/assisting devices (snare, guidewire, bal- a concern. Our preferred solution for irrigation in the CBD loon extraction catheter, balloon dilator, extraction basket, is 0.9% normal saline, as it also aids in conducting the electri- rat-tooth forceps, stent retriever, etc.). Anesthesia or sedation cal impulse required for EHL. Once the stone was visualized, and reimbursement of all personnel involved in the procedure, EHL was performed using the Autolith EHL generator and a including the gastroenterologist, nursing staff, technical sta ff 1.9 French (Fr) EHL probe (Nortech, Northgate Technologies, and anesthesiologist—if present—were also added to the total Elgin, IL, USA). An initial power setting of 50 watts and a fre- cost (Table 1). Costs associated with any adverse event, subse- quency of five pulses per second were used, but depending upon quent surgery or hospital stay arising from the procedure were the impact on the stone, these parameters were changed during also included in this cost analysis. The upfront capital cost to the procedure. The number of EHL applications was purely at purchase the SOPOC system was not included in the cost anal- the discretion of the endoscopist based on visual fissuring and ysis. Similarly, we did not include capital cost for the purchase fragmentation of the stone. W hen the stone was optimally frag- of surgical instruments. mented, the SOPOC system was removed, and then conven- The average actual cost of SOPOC was compared with the tional means of stone extraction by standard ERCP were used calculated costs of surgical alternatives, such as OCBDE and to clear the CBD of all fragments. A stent was only replaced if LCBDE. This projected surgical cost included reimbursement duct clearance could not be guaranteed and a repeat procedure of the surgeon, anesthesiologist, nursing and technical staff, and was being contemplated. Repeat ERCP with or without chol- the cost related to the postoperative length of stay (LOS) in angioscopy was performed as necessary and at the discretion hospital (Table 2). The average LOS was extracted from expert of the endoscopist. Clinical success was defined as complete opinion from our local surgeons and from published data from clearance of the CBD (Figure  2) as evidenced by cholangiog- the provincial Alberta Health Services (AHS) database. For raphy done during the index procedure or on any subsequent the purposes of this study, the accepted LOS was two days for procedure done to extract any remaining fragments. LCBDE and four days for OCBDE. Published literature, how- The average cost per case of extracting a difficult CBD ever, has LOS data (average LOS for LCBDE 4.2 days and for stone (or stones) was calculated by adding the cumula- OCBDE 12.6 days) that does not reflect the current pae tt rn of tive costs of all ERCPs conducted following the initial failed practice at our hospital (12). We chose not to include the addi- ERCP. This included the index SOPOC and any subsequent tional cost of a cholecystectomy (for those patients that had ERCPs with or without cholangioscopy until the CBD was concomitant cholelithiasis), as our intent is simply to compare clear. These include the cost of the SOPOC (Legacy or DS), the costs associated with therapeutic intervention for difficult Figure 2. ERCP images of the common bile duct before (A) and ae ft r (B) extraction of multiple stacked stones with complete clearance of CBD. Downloaded from https://academic.oup.com/jcag/advance-article-abstract/doi/10.1093/jcag/gwy021/4994575 by Ed 'DeepDyve' Gillespie user on 07 June 2018 4 Journal of the Canadian Association of Gastroenterology, 2018, Vol. XX, No. XX Table 1. Cost, in $CDN, of ERCP (with SpyGlass+EHL) CBD stones. All costs were calculated based on the current Alberta Health Services reimbursement schedule. Diagnostic imaging component Radiology tech time, benefits, and clerical costs 55.56 STATISTICS Radiographic film (digital) and contrast 81.84 Fluoroscopy equipment service package (per 31.25 Descriptive statistics were used for continuous variables using case) ($25,000 per year/800 ERCPs) mean or median, as appropriate, along with their corresponding Radiologist reimbursement fee 29.03 95% confidence intervals. Gastroenterology Component Nursing salary and benefits RESULTS (RN for procedure room and LPN for recovery room) Patient Characteristics RN 60.25 Between April 2011 and June 2015, 51 patients were referred to LPN 39.94 the UAH for SOPOC for difficult CBD stones ( Table 3). There Medications (unit price) were 35 females (69%), and the mean age was 66 years (range Midazolam (per mg) 1.25 30–88 years). Referrals were from received from other tertiary Fentanyl (per 100 μg) 0.44 care hospitals in adjacent provinces (3 of 51 patients, 6%), local Diazemuls (per 5 mg) 1.15 and regional community hospitals (13 of 51 patients, 25%) and Medical and surgical supplies (including gloves, 80.00 from other endoscopists at our own hospital (35 of 51 patients, IV tubing, O2 tubing etc.), scope disinfection and 69%). Difficult CBD stones ( Figure  1) were defined as those laundry that were single-large (26 of 51), multiple-large and stacked (15 Endoscopy equipment service package (service 12.00 of 51), faceted (one of 51), impacted (seven of 51) or located contract with vendor per ERCP) proximal to a stricture in the CBD (eight of 51). There was over - SpyGlass cost/case (Legacy and DS) lap of categories in seven patients. Legacy ($950+$375) 1325.00 A total of 58 ERCPs with SOPOC were performed in these DS (based on purchase of a pack of 10 probes) 1695.00 51 patients by a single endoscopist (GS). All ERCPs were per- EHL probe (single use) 395.00 formed using the Olympus TJ180 side-viewing duodenoscope SpyBite forceps 595.00 (Olympus America, Melville, NY USA). Of these 58 SOPOC Sphincterotome 275.00 Balloon extraction catheter 140.00 procedures, 49 were performed with the original SpyGlass Locking device 90.00 Legacy system and nine with the SpyGlass Digital system that Snare 11.00 was acquired in April 2015 (Figure  3). The median time per Extraction basket 270.00 procedure was 67 ± 6.5 minutes (95% confidence interval, 61.5– Balloon dilator 150.00 73.5), calculated from 56 of the 58 procedures for which proce- Guide wire 100.00 dure time was noted. The range of time for the whole cohort was Stent—Plastic 145.00 24–124 minutes. The total time per procedure includes not only Stent—Metal 1300.00 the time spent on SOPOC and EHL but also the time spent on Soehendra stent retriever 199.00 extracting the stone fragments. Forty-eight of these procedures Rat-tooth forceps 171.00 were done under general anesthesia (with an ae tt ndant anesthesi - Gastroenterologist reimbursement fees ologist), and 10 were done with topical xylocaine anesthesia and ERCP 262.18 conscious sedation using midazolam and fentanyl (administered Cholangioscopy 164.85 and monitored by the nurse and endoscopist). Electrohydraulic lithotripsy 113.99 Twenty-seven patients previously underwent cholecystec- Stone extraction 57.00 tomy (Table  3). Two had a cholecystectomy ae ft r a successful Anesthesia Component removal of CBD stones by SOPOC, one underwent cholecys- Anesthesia machine service package 27.00 tectomy with CBDE ae ft r a failed SOPOC, and one had an Anesthesia cost/case for GA (cost of gases, 100.00 open CBDE ae ft r a failed SOPOC. One patient with a prior tubing, ECG leads etc.) cholecystectomy also had undergone a failed CBDE prior to Anesthesia tech time and benefits ($50/hr) 50.00 referral for SOPOC. Anesthesiologist reimbursement 217.20 A total of 108 ERCPs were performed before referral for ($18.10 per 5 min) SOPOC. Twenty-three patients had one ERCP, 19 patients had Inpatient component two ERCPs, four patients had three ERCPs, one patient had 4, Cost of medical ward/day 973.00 one patient had 6, while one patient had 25 ERCPs (for routine Downloaded from https://academic.oup.com/jcag/advance-article-abstract/doi/10.1093/jcag/gwy021/4994575 by Ed 'DeepDyve' Gillespie user on 07 June 2018 Journal of the Canadian Association of Gastroenterology, 2018, Vol. XX, No. XX 5 Table 2. Cost, in $CDN, of CBD exploration ($CDN) Diagnostic imaging component OCBDE LCBDE (For intra-operative cholangiogram) Radiology tech time, benefits, and clerical costs 55.56 55.56 Radiographic film (digital) and contrast 81.84 81.84 Fluoroscopy equipment service package (per case) 31.25 31.25 Radiologist reimbursement fee 29.03 29.03 Surgery Component Nursing salary and benefits (2–3 nurses for the procedure including recovery room) 836.00 762.00 Medical and surgical supplies (including surgical kit, gloves, IV tubing, O2 tubing etc.), sterilization 620.00 1280.00 and laundry Biliary Fogarty catheters (3–5 Fr) 39.24 39.24 Specimen collection bag 180.00 180.00 Guide wire 42.00 42.00 8 mm balloon dilator 140.00 140.00 Choledochoscope cost per case (with light source/monitor etc., service contact with vendor) 12.00 12.00 Loop ligatures 6.41 6.41 T-tube 15.00 15.00 Surgeon reimbursement fee 1024.28 1024.28 Hospital LOS 4 days 2 days Anesthesia Component Anesthesia machine service package 27.00 27.00 Anesthesia cost/case for GA (cost of gases, tubing, ECG leads etc.) 100.00 100.00 Anesthesia tech time and benefits ($50/hr) 91.66 75.00 Anesthesiologist reimbursement ($18.10 per 5 min) 398.20 325.80 Inpatient component Cost of ICU/day 3296.00 3296.00 Cost of surgical ward/day 1044.00 1044.00 plastic stent replacement every three months over the previ- patients, the CBD stones were above a stricture and not of a size ous five years) before SOPOC. This last patient was found to for which EHL was necessary (the strictures were deemed to be have a 4  cm CBD stone that was not amenable to endoscopic the more clinically relevant and significant pathology); in the extraction, and she was deemed not to be a surgical candi- remaining two patients, stones were deemed to be of a size small date by her local surgeon. One patient was referred directly for enough that they were extracted without the need for EHL. SOPOC without a prior ERCP. On an intention-to-treat basis (i.e., with the intent of refer- ral for SOPOC being clearance of the duct), SOPOC was Clinical Success successful in clearing the CBD in 47 of 51 patients (overall effi - All patients referred for SOPOC underwent cholangioscopy cacy 93%). The presence of a CBD stricture precluded stone prior to cholangiography. Of the 58 SOPOC procedures, EHL extraction in two patients (one with primary sclerosing cholan- was performed in 52 procedures by utilizing 53 probes (one gitis and one with a benign stone-induced stricture), and the patient required a second EHL probe ae ft r the first one had stones were of a size that did not warrant EHL. One patient had burnt out, presumably because of prolonged use). Successful a large stone impacted at the cystic duct confluence with the fragmentation of stone(s) and extraction with duct clearance CBD and could not be fragmented by EHL. This patient under - were possible in 50 of 52 procedures where EHL was used went OCBDE and was found to have Mirizzi’s syndrome and (overall therapeutic efficacy of EHL: 96%) for difficult CBD required repair of the cholecyst-choledochal fistula. Another stones. The actual number of pulses fired was not calculated, patient had a 4–5  cm stone concretion around a metal stent and the duration of EHL was purely based on the discretion of placed five years previously for a benign CBD stricture. EHL the endoscopist based on visual evidence of fracturing and frag- was unsuccessful, and a second, longer metal stent was placed mentation. EHL was not used in six procedures: in two patients, for drainage. there were no stones visible in the CBD on cholangioscopy, and In eight patients, an additional 14 ERCPs were performed cholangiography revealed a clear duct as well; in another two ae ft r SOPOC. Two of these patients had a total of seven ERCPs, Downloaded from https://academic.oup.com/jcag/advance-article-abstract/doi/10.1093/jcag/gwy021/4994575 by Ed 'DeepDyve' Gillespie user on 07 June 2018 6 Journal of the Canadian Association of Gastroenterology, 2018, Vol. XX, No. XX Figure 3. SpyGlass Legacy images (A and B) and SpyGlass DS images (C and D) before and ae ft r fragmentation of stone. but the indication for these subsequent procedures was a CBD post-ERCP pancreatitis despite a previous sphincterotomy, and stricture rather than the stone. Therefore, the cost of these extra this resulted in a four-day hospital stay. procedures was not factored into the overall cost of SOPOC. Cost Comparison In the remaining six patients, seven ERCPs were required to clear the CBD of remnant fragments of stone. The cost associ - The average cost of SOPOC was $4555±$2647 (range $2538– ated with these procedures was included in the overall cost of $14,923). We calculated the cost of OCBDE and LCBDE to SOPOC. be $7766 and $6175, respectively. The cost saved per patient by performing SOPOC compared with OCBDE and LCBDE Adverse Events was $3211 and $1620, respectively. The rate of adverse events A total of seven patients (14%) suffered minor adverse events for CBDE as extracted from published data is 3.2%. The total from SOPOC. Four patients suffered mild bleeding from the treatment cost of the most common surgical adverse events was CBD as a result of contact trauma from EHL (Figure 4). All of calculated to be $4977 for a bile leak, $5216 for an intra-abdom- these were self-resolving, as observed during direct cholangios- inal hemorrhage, and $3701 for an intra-abdominal abscess. copy, and did not require any further intervention. One patient These costs have not been added to the cost of OCBDE and was noticed to have a tear at the gastroesophageal junction. We LCBDE listed above. feel this occurred as a result of snare extraction of an 11.5 Fr stent. Ae ft r the ERCP was completed, this tear was repaired DISCUSSION with eight clips placed with a gastroscope, and the patient did Difficult CBD stones can present technical challenges to ae tt mpts well. One patient with stone fragments in the cystic duct stump at removal during ERCP. These stones are large (single or multi - with a prior cholecystectomy incurred a cystic duct stump ple and stacked), faceted (square-shaped), impacted or situated leak caused by the guidewire used for the stone extraction. proximal to a stricture, and thus not amenable to conventional A plastic stent was inserted during the Spyglass ERCP and was modalities of treatment such as balloon extraction or engagement removed in a subsequent ERCP. One patient developed acute Downloaded from https://academic.oup.com/jcag/advance-article-abstract/doi/10.1093/jcag/gwy021/4994575 by Ed 'DeepDyve' Gillespie user on 07 June 2018 Journal of the Canadian Association of Gastroenterology, 2018, Vol. XX, No. XX 7 Table 3. Patient characteristics Patients (n) 51 Age in years, mean (range) 66 (30–88) Gender (F) 35 Indication for SOPOC/EHL (n) Single large stone 26 Multiple stacked stones 15 Faceted stone 1 Impacted stone 7 Stone proximal to stricture 8 Prior cholecystectomy (n) 27 Prior ERCPs (n) 108 SOPOCs (n) 58 SOPOC procedure time (minutes), 67 (61.5, 73.5) median (95% CI) (range) (24–124) Adverse events secondary to 87 SOPOC/EHL Spontaneously-resolving 4 EHL -induced CBD trauma Figure  4. Mild trauma (black arrow) to the common bile duct from electrohydraulic litho- GE junction tear (plastic 1 tripsy probe (white arrow). stent-induced) Wire-induced CD stump leak 1 within the CBD. The original SpyGlass Legacy system has Post-ERCP pancreatitis 1 recently been upgraded to the Digital SpyGlass system with Subsequent procedures significant improvements, such as enhanced optical resolution, ERCP 14 wider field of view and bee tt r operator handling. Using the Cholecystectomy 2 SOPOC system in our referral institution, we achieved a tech- OCBDE 1 nical success rate of 96%, with fragmentation of difficult CBD LC-OC+CBDE 1 stones with EHL and a duct clearance rate of 93% on an inten- tion-to-treat basis. These results are in keeping with a recent GE, gastro-esophageal; CD, cystic duct; LC-OC, laparoscopic meta-analysis of 31 studies showing a technical success rate cholecystectomy converted to open cholecystectomy. of 91% and stone clearance in 88% (15). However, there have been no studies comparing the cost of cholangioscopy with within a retrieval basket. Additional interventions such as conventional alternatives such as surgical bile duct exploration. mechanical lithotripsy and balloon sphincteroplasty may also not Adverse events seen in our study were higher than that be helpful because of size, shape or impaction of the stone(s). reported with CBDE (14% versus 3.2%), but they were all The options for removal of such difficult CBD stones are minor and self-resolving, except one patient requiring a four- extra-corporeal shock-wave lithotripsy (ESWL), cholangios- day hospitalization for mild post-ERCP pancreatitis. Adverse copy with intra-ductal lithotripsy (with EHL or laser) and events associated with surgery (e.g., bile leak, intra-abdominal CBDE. In a comparative study, POC with laser lithotripsy was hemorrhage, or intra-abdominal abscess) are more severe and found to be more effective and safer than ESWL for fragmen- have a greater impact on patient quality of life and longer hospi- tation of CBD stones (97% versus 73%, respectively) (13). tal LOS, which further adds to health care resource utilization. Furthermore, ESWL requires subsequent ERCP for removal In the Canadian health care system, the upfront capital cost of fragmented stones. POC using mother-baby cholangioscopy of investing in a SOPOC system, such as the SpyGlass system, with EHL reported stone clearance in 90% of patients (14). The is a significant deterrent to the acquisition of such technol - authors recommend the use of POC as the first line treatment ogy. However, our study shows that even in the small subset for difficult stones before using other modalities. However, of patients with difficult CBD stones who pose a significant because of the fragility of the baby endoscope, mother-baby medical challenge, the procedure is very effective and has an cholangioscopy has fallen out of favour amongst most biliary excellent safety profile. We believe this justifies the adoption of endoscopists. SOPOC in a limited number of specialized centers so that the With the introduction of the SOPOC system, there has been technology is available for direct patient care. In addition, the renewed interest in the diagnostic and therapeutic abilities significant cost savings realized by avoiding alternative methods Downloaded from https://academic.oup.com/jcag/advance-article-abstract/doi/10.1093/jcag/gwy021/4994575 by Ed 'DeepDyve' Gillespie user on 07 June 2018 8 Journal of the Canadian Association of Gastroenterology, 2018, Vol. XX, No. XX of intervention—especially surgery (LCBDE and OCBDE— LCBDE and pre- or post-cholecystectomy ERCP. However, show that the technology is cost effective. they do not address the specific question of difficult CBD Our study analyzed the actual costs of SOPOC for difficult stones but instead deal with the issue of CBD stones when a CBD stones compared with the alternative of surgical inter- cholecystectomy also needs to be done. In our cohort of 51 vention. Most of the studies comparing endoscopic with surgi- patients, 27 patients (53%) already had a previous cholecys- cal management of CBD stones address the issue in the context tectomy and would have had to undergo another surgical pro- of cholecystectomy. A  recent Cochrane review suggested the cedure in the event of failure of endoscopic treatment of these superiority of OCBDE over ERCP in managing CBD stones difficult CBD stones. based on data from early endoscopic studies (2). They found It is also important to note that our patient cohort had previ- no differences in the clinical efficacy or outcomes comparing ously undergone an average of more than two ERCP procedures Figure 5. Proposed algorithm for management of common bile duct (CBD) stones. ERCP, Endoscopic retrograde cholangiopancreatography; CBD, Common bile duct; DASE, Dilation-assisted stone extraction; SOPOC, Single-operator per oral cholangioscopy; EHL, electrohydraulic lithotripsy; LCBDE, laparoscopic common bile duct exploration; OCBDE, open common bile duct exploration. Downloaded from https://academic.oup.com/jcag/advance-article-abstract/doi/10.1093/jcag/gwy021/4994575 by Ed 'DeepDyve' Gillespie user on 07 June 2018 Journal of the Canadian Association of Gastroenterology, 2018, Vol. XX, No. XX 9 before being referred for SOPOC for difficult stones. We believe cost-per-case savings compared with surgical management offsets that further cost savings can be realized with the appropriate and the upfront capital cost and ongoing operational costs required timely identification of difficult CBD stones. Based on our experi - for SOPOC and EHL. We recommend that SOPOC with EHL ence, we propose an algorithmic approach to the management of be adopted as the standard of care for treatment of difficult CBD these difficult CBD stones ( Figure  5). Patients with CBD stones stones ae ft r failure of conventional ERCP before CBDE. should undergo routine ERCP with conventional methods of stone removal such as sphincterotomy followed by balloon or ACKNOWLEDGMENTS basket extraction. If unsuccessful, advanced interventions such The authors wish to acknowledge the assistance of Ralph Ennis-Davis as mechanical lithotripsy and balloon sphincteroplasty should be (Endoscopy Unit Manager, University of Alberta Hospital) and Dr. performed during the index ERCP. If the endoscopist is not com- Michael Murphy, Dr. Barry Finegan (Department of Anesthesiology, fortable with these techniques, the patient should be referred to a University of Alberta Hospital) and Dr. Ronald Brisebois (Department tertiary care facility. Failure of these advanced interventions defines of Surgery, University of Alberta Hospital) for their assistance in pro- difficult CBD stones and the patient should be referred for SOPOC viding data information for this manuscript. Ethics approval was for further management. Streamlining and minimizing unneces- obtained from the Ethics Review Board of the University of Alberta sary procedures can realize further healthcare resource savings. (Study # Pro00057683). Author contributions: JS and GS acquired, We recognize that anesthesia services are not readily available analyzed and interpreted data. JS wrote the manuscript. JS, SVVZ and at many centres. GA definitely allowed for a very comfortable GS revised the manuscript and gave final approval. procedure, not only for the patient but for the endoscopist as Conflicts of Interest well, because these procedures can be fairly lengthy and labori- Dr. Gurpal Sandha is a consultant and member of the biliary medical ous. Also, since a significant amount of saline is required for irri - advisory board for Boston Scientific Corporation and has received honoraria for speaking and proctoring. Jaskiran Sandha and Dr. gation, and because some of this fluid can sequester in the fundus Sander Veldhuyzen van Zanten have no conflicts of interest relevant of the stomach with patients being in the left lateral position, to this study. endotracheal intubation ensured airway protection. Because the average procedure time for our cohort was slightly over an hour, GA was felt to be more beneficial than conscious sedation, References especially in the extremely time-consuming cases. Other than the ease of performing procedures under GA, we do not feel 1. Soltan HM, Kow L, Toouli J. A simple scoring system for predicting that GA had any impact on the high rate of success. Procedures bile duct stones in patients with cholelithiasis. J Gastrointest Surg. can be performed equally effectively provided patients are well 2001;5(4):434–7. 2. Dasari BV, Tan CJ, Gurusamy KS, et  al. Surgical versus endo- sedated with conscious sedation. However, if this is not possible, scopic treatment of bile duct stones. Cochrane Database Syst Rev we highly recommend repeating the procedure with GA. 2013;12:CD003327. There are several limitations of our study. First, this is a sin- 3. Brown LM, Rogers SJ, Cello JP, et  al. Cost-effective treatment of gle-centre, single-operator experience that brings into question patients with symptomatic cholelithiasis and possible common the generalizability of the results. However, the authors believe bile duct stones. J Am Coll Surg 2011;212(6):1049–60.e1–7. that similar results are achievable when procedures are done in a 4. Binmoeller KF, Schafer TW. Endoscopic management of bile duct high-volume facility. Furthermore, most of the cases described stones. J Clin Gastroenterol 2001;32(2):106–18. were performed with the original SpyGlass Legacy system. The 5. McHenry L, Lehman G. Difficult bile duct stones. Curr Treat new Digital SpyGlass platform is significantly improved and Options Gastroenterol 2006;9(2):123–32. makes it easier to achieve operator performance. Secondly, this 6. Neuhaus H. Endoscopic and percutaneous treatment of difficult is a retrospective observational study and does not address the bile duct stones. Endoscopy 2003;35(8):S31–4. comparison of efficacy and costs in a randomized, prospective 7. van der Velden JJ, Berger MY, Bonjer HJ, et al. Percutaneous treat- ment of bile duct stones in patients treated unsuccessfully with manner. Moreover, because this is a comparison of actual costs endoscopic retrograde procedures. Gastrointest Endosc 2000;51(4 of SOPOC versus calculated estimates of CBDE, we may have Pt 1):418–22. underestimated the true cost of surgical intervention, which 8. Yasuda I, Itoi T. Recent advances in endoscopic management of dif- may be greater due to adverse events not mentioned in this ficult bile duct stones. Dig Endosc 2013;25(4):376–85. report and the associated increase in hospital LOS. So, in real- 9. Trikudanathan G, Arain MA, Aatt m R, et  al. Advances in the ity, the true difference in cost between SOPOC and CBDE may endoscopic management of common bile duct stones. Nat Rev actually be greater than we have described. Gastroenterol Hepatol 2014;11(9):535–44. In summary, SOPOC with EHL, done on an outpatient basis, 10. Alameel T, Bain V, Sandha G. Clinical application of a single-oper- is a highly effective treatment modality for difficult CBD stones ator direct visualization system improves the diagnostic and ther- and offers a less invasive approach compared with conventional apeutic yield of endoscopic retrograde cholangiopancreatography. surgical management by CBDE. Our study demonstrates that the Can J Gastroenterol 2013;27(1):15–9. Downloaded from https://academic.oup.com/jcag/advance-article-abstract/doi/10.1093/jcag/gwy021/4994575 by Ed 'DeepDyve' Gillespie user on 07 June 2018 10 Journal of the Canadian Association of Gastroenterology, 2018, Vol. XX, No. XX 11. Chen YK, Parsi MA, Binmoeller KF, et  al. Single-operator chol- lithotripsy for difficult bile duct stones. Gastrointest Endosc angioscopy in patients requiring evaluation of bile duct disease 1998;47(5):327–34. or therapy of biliary stones (with videos). Gastrointest Endosc 14. Arya N, Nelles SE, Haber GB, et  al. Electrohydraulic lithotripsy 2011;74(4):805–14. in 111 patients: A  safe and effective therapy for difficult bile duct 12. Grubnik VV, Tkachenko AI, Ilyashenko VV, et  al. Laparoscopic stones. Am J Gastroenterol 2004;99(12):2330–4. common bile duct exploration versus open surgery: Comparative 15. Korrapati P, Ciolino J, Wani S, et  al. The efficacy of peroral chol - prospective randomized trial. Surg Endosc 2012;26(8):2165–71. angioscopy for difficult bile duct stones and indeterminate stric - 13. Neuhaus H, Zillinger C, Born P, et  al. Randomized study of tures: A  systematic review and meta-analysis. Endosc Int Open intracorporeal laser lithotripsy versus extracorporeal shock-wave 2016;4(3):E263–75. Downloaded from https://academic.oup.com/jcag/advance-article-abstract/doi/10.1093/jcag/gwy021/4994575 by Ed 'DeepDyve' Gillespie user on 07 June 2018

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Journal of the Canadian Association of GastroenterologyOxford University Press

Published: May 10, 2018

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