Endoscopic sphincterotomy to prevent post-ERCP pancreatitis after self-expandable metal stent placement for distal malignant biliary obstruction (SPHINX): a multicentre, randomised controlled trial.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) with fully covered self-expandable metal stent (FCSEMS) placement is the preferred approach for biliary drainage in patients with suspected distal malignant biliary obstruction (MBO). However, FCSEMS placement is associated with a high risk of post-ERCP pancreatitis (PEP). Endoscopic sphincterotomy prior to FCSEMS placement may reduce PEP risk. OBJECTIVE: To compare endoscopic sphincterotomy to no sphincterotomy prior to FCSEMS placement. DESIGN: This multicentre, randomised, superiority trial was conducted in 17 hospitals and included patients with suspected distal MBO. Patients were randomised during ERCP to receive either endoscopic sphincterotomy (sphincterotomy group) or no sphincterotomy (control group) prior to FCSEMS placement. The primary outcome was PEP within 30 days. Secondary outcomes included procedure-related complications and 30-day mortality. An interim analysis was performed after 50% of patients (n=259) had completed follow-up. RESULTS: Between May 2016 and June 2023, 297 patients were included in the intention-to-treat analysis, with 156 in the sphincterotomy group and 141 in the control group. After the interim analysis, the study was terminated prematurely due to futility. PEP did not differ between groups, occurring in 26 patients (17%) in the sphincterotomy group compared with 30 patients (21%) in the control group (relative risk 0.78, 95% CI 0.49 to 1.26, p=0.37). There were no significant differences in bleeding, perforation, cholangitis, cholecystitis or 30-day mortality. CONCLUSION: This trial found that endoscopic sphincterotomy was not superior to no sphincterotomy in reducing PEP in patients with distal MBO. Therefore, there was insufficient evidence to recommend routine endoscopic sphincterotomy prior to FCEMS placement. TRIAL REGISTRATION NUMBER: NL5130.

Sphincterotomy for biliary sphincter of Oddi disorder and idiopathic acute recurrent pancreatitis: the RESPOnD longitudinal cohort.

OBJECTIVE: Sphincter of Oddi disorders (SOD) are contentious conditions in patients whose abdominal pain, idiopathic acute pancreatitis (iAP) might arise from pressurisation at the sphincter of Oddi. The present study aimed to measure the benefit of sphincterotomy for suspected SOD. DESIGN: Prospective cohort conducted at 14 US centres with 12 months follow-up. Patients undergoing first-time endoscopic retrograde cholangiopancreatography (ERCP) with sphincterotomy for suspected SOD were eligible: pancreatobiliary-type pain with or without iAP. The primary outcome was defined as the composite of improvement by Patient Global Impression of Change (PGIC), no new or increased opioids and no repeat intervention. Missing data were addressed by hierarchal, multiple imputation scheme. RESULTS: Of 316 screened, 213 were enrolled with 190 (89.2%) of these having a dilated bile duct, abnormal labs, iAP or some combination. By imputation, an average of 122/213 (57.4% (95% CI 50.4% to 64.4%)) improved; response rate was similar for those with complete follow-up (99/161, 61.5% (54.0% to 69.0%)); of these, 118 (73.3%) improved by PGIC alone. Duct size, elevated labs and patient characteristics were not associated with response. AP occurred in 37/213 (17.4%) at a median of 6 months post ERCP and was more likely in those with a history of AP (30.9% vs 2.9%, p<0.0001). CONCLUSION: Nearly 60% of patients undergoing ERCP for suspected SOD improve, although the contribution of a placebo response is unknown. Contrary to prevailing belief, duct size and labs are poor response predictors. AP recurrence was common and like observations from prior non-intervention cohorts, suggesting no benefit of sphincterotomy in mitigating future AP episodes.

Prophylactic use of a self-assembling peptide hydrogel for preventing delayed bleeding after endoscopic sphincterotomy: A propensity score-matched analysis.

BACKGROUND AND AIM: Delayed endoscopic sphincterotomy-related bleeding (ES bleeding) is an unavoidable adverse event (AE) that can have serious ramifications. Intraoperative ES bleeding, which stops spontaneously in most cases, is a known risk factor for delayed bleeding. This study aimed to examine the preventive effect of a novel self-assembling peptide (SAP) for delayed ES bleeding in patients who attained spontaneous hemostasis after intraoperative ES bleeding. METHODS: A total of 1507 patients met the eligibility criteria for inclusion in this study. The rates of delayed ES bleeding and AE besides bleeding were compared between patients administered the SAP (SAP group) and those who were simply observed after spontaneous hemostasis of intraoperative ES bleeding (control group). Propensity score matching was performed to adjust for differences between the groups. RESULTS: The rate of delayed ES bleeding was significantly lower in the SAP group than that in the control group (0.9% vs 3.8%, P = 0.044). The rates of AEs other than bleeding were 2.4% and 3.8% in the SAP and control groups, respectively, and the difference lacked statistical significance (P = 0.481). Multivariate analysis revealed that the use of SAP was significantly associated with a lower frequency of delayed ES bleeding (odds ratio, 0.35; 95% confidence interval, 0.13-0.98; P = 0.047). CONCLUSIONS: Self-assembling peptide may be a simple, safe, and useful way to reduce the risk of delayed ES bleeding in patients who experienced intraoperative ES bleeding and obtained subsequent spontaneous hemostasis.

A Novel Dry Simulator Model for Learning Comprehensive Endoscopic Retrograde Cholangiopancreatography/Endoscopic Sphincterotomy Procedures while Minimizing Adverse Bleeding Events (with Video).

INTRODUCTION: Endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic sphincterotomy (EST) are essential skills for performing endoscopic cholangiopancreatic procedures. However, these procedures have a high incidence of adverse events, and current training predominantly relies on patient-based approaches. Herein, we aimed to develop an ERCP/EST simulator model to address the need for safer training alternatives, especially for learners with limited ERCP experience. METHODS: The model was designed to facilitate the use of actual endoscopic devices, supporting learning objectives that align with the components of the validated Bethesda ERCP Skill Assessment Tool (BESAT). BESAT focuses on skills, such as papillary alignment, maintenance of duodenoscope position, gentle and efficient cannulation, controlled sphincterotomy in the correct trajectory, and guidewire manipulation. Thirty gastroenterology trainees used the simulator between May 2022 and March 2023, and their satisfaction was assessed using a visual analog scale (VAS) and pre- and post-training questionnaires. RESULTS: The novel simulator model comprised a disposable duodenal papillary section, suitable for incision with an electrosurgical knife, alongside washable upper gastrointestinal tract and bile duct sections for repeated use. The duodenal papillary section enabled reproduction of a realistic endoscope position and the adverse bleeding events due to improper incisions. The bile duct section allowed for the reproduction of fluoroscopic-like images, enabling learners to practice guidewire guidance and insertion of other devices. Following training, the median VAS score reflecting the expectation for model learning significantly increased from 69.5 (interquartile range [IQR]: 55.5-76.5) to 85.5 (IQR: 78.0-92.0) (p < 0.01). All participants expressed a desire for repeated simulator training sessions. CONCLUSIONS: This innovative simulator could serve as a practical educational tool, particularly beneficial for novices in ERCP. It could facilitate hands-on practice with actual devices, enhancing procedural fluency and understanding of precise incisions to minimize the risk of bleeding complications during EST.

Curative surgical treatment of common bile duct stones: Retrospective cohort study.

BACKGROUND: In the event of symptomatic common bile duct (CBD) stones with dilated CBD, one possible curative treatment option is stone extraction through choledocotomy associated with cholecystectomy. Endoscopic treatment is only reserved for residual stones at 6 weeks. The aim of this study was to evaluate the results from laparoscopic curative surgical treatment of CBD stones with dilated CBD. METHODS: This is a retrospective single-centered cohort study. All consecutive patients admitted for laparoscopic cholecystectomy with evidence of CBD stones with dilated CBD from January 2010 to December 2020 at our center were included. Success was defined by CBD clearance at 6 weeks. Need for additional procedures, such as endoscopic sphincterotomy, immediate, and end-of-procedure morbi-mortality as well as factors associated with procedure failure, were also studied. RESULTS: A total of 246 patients who received curative treatment were included in the study. The success rate for the curative treatment was 93.1% (229 patients). Immediate postoperative morbidity was 24.4% with a 5.3% reintervention rate. Immediate and 6-week postoperative mortality rates were zero and 0.4%, respectively. The mean length of stay was 11.3 days. Factors associated with procedure failure appeared to be the occurrence of an early postoperative complication and the need for readmission during the period between surgery and drain removal. CONCLUSION: This study indicates that laparoscopic curative surgical treatment for symptomatic CBD stones may be performed with acceptable results without routine need for additional procedures.

Enlarged fistulotomy of the papilla as access to the biliary tract during ERCP.

BACKGROUND: Demonstration of access to the bile duct through Enlarged Papillary Fistulotomy, a method different from conventional fistulotomy. AIMS: Demonstration of the EFP technique with dissection in layers of the papilla for accessing the common bile duct, its efficiency and safety, rescue of cases of failure in cannulation and cases of access failure by EFP in the first attempt, facilitating cannulation in the second attempt. METHODS: Cross-sectional study, with retrospective data collection from 2233 ERCP exams with 528 EFP procedures, analysis of success and complications. RESULTS: 528 patients underwent EFP on the first attempt, with success in 465 cases (88.06%) and 63 failures (11.94%). Of these failures, 33 patients (52.38%) returned for a second EFP attempt, with success in 30 cases (90.9%) and failure in 3 cases (9.1%). Deep bile duct cannulation was achieved in 93.75% of EFP procedures, and cannulation failure occurred in 33 cases (6.25%). CONCLUSION: EFP showed efficiency in CBD cannulation, did not induce post-ERCP pancreatitis, no cases of perforation or false tract, but resulted in higher rates of minor bleeding, rescued cases of access failure by EFP, facilitated the posterior approach on the second attempt, it is safe, effective, low risk and associated with few comorbidities.

Feasibility and safety of partial ampullary endoscopic mucosal resection: a novel technique for difficult biliary cannulation (with video).

BACKGROUND: Biliary cannulation can be challenging even for expert endoscopists, and rescue techniques are limited. Our objective was to determine the feasibility and safety of partial ampullary endoscopic mucosal resection (PA-EMR), a novel technique for biliary cannulation. METHODS: Monocentric, retrospective analysis of a prospectively maintained database in a tertiary referral university hospital. Fourteen patients who required endoscopic retrograde cholangiopancreatography (ERCP) and underwent PA-EMR between January 1, 2020 and January 31, 2021 were included. For biliary cannulation of prominent papillae, PA-EMR was performed using a standard polypectomy snare, alone or in combination with needle-knife sphincterotomy. In patients with non-prominent papilla, the papillary mucosa was elevated with the aid of methylene blue injection before resection and combined with needle-knife fistulotomy when needed. The rate of technical success and adverse events was assessed. RESULTS: The bile duct cannulation success was 99% in the first attempt and 100% overall with the PA-EMR technique. Only one patient experienced mild bleeding, which spontaneously stopped. CONCLUSION: PA-EMR is an effective technique that may be considered as a rescue technique for difficult biliary cannulation in expert hands. Future studies including larger cohorts and comparisons with other techniques are warranted to further confirm the feasibility and safety of this novel technique.

Efficacy and safety of three endoscopic techniques for small common bile duct stones (≤ 10 mm): a multicenter, retrospective, cohort study with propensity score matching.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) is a major option for common bile duct (CBD) stones. Endoscopic sphincterotomy (EST), endoscopic papillary balloon dilatation (EPBD), and endoscopic sphincterotomy plus balloon dilatation (ESBD) are procedures for opening the bile duct orifice to extract CBD stones during ERCP. The optimal method for extracting small CBD stones (≤ 10 mm) has not yet been proposed. We aimed to compare the efficacy and safety of these three techniques in extracting small CBD stones. METHODS: ERCP for small stones was performed between January 2009 and November 2020 at three tertiary care centers. The incidence of post-ERCP pancreatitis (PEP) was compared among EST, EPBD, and ESBD groups. First and overall success rates of stone extraction, utilization rate of mechanical lithotripsy, and other ERCP complications such as bleeding, perforation, infection, and hyperamylasemia were compared. RESULTS: A total of 2181 patients were enrolled between January 2009 and November 2020. The proportion of young patients (≤ 45 years) in EPBD group was more than those in EST and ESBD group. Stone size in ESBD group was much larger than EST and EPBD group. After propensity score matching, the success rates of first and overall stone extraction in the three groups were high, and the rates of mechanical lithotripsy were low, with no significant difference. The PEP incidences showed no differences among the three groups. The incidence of bleeding complication in EST group was higher than that in EPBD group. No significant differences were observed in other complications between EPBD group and ESBD group. ESBD group had higher incidence of overall, infection, and hyperamylasemia complications than EST group. CONCLUSION: EPBD is equivalent to ESBD in stone removal efficiency and complication rate, but brings a lower bleeding risk than EST. Therefore, we recommend EPBD as the first choice for small CBD stones.

The efficacy and safety of endoscopic sphincterotomy in patients with Sphincter of Oddi dysfunction: a systematic review and meta-analysis.

OBJECTIVE: Sphincter of Oddi dysfunction (SOD) has been used to describe patients with RUQ abdominal pain without an etiology. We conducted a systematic review and meta-analysis to evaluate the efficacy and safety of ES (endoscopic sphincterotomy) for SOD. METHODS: The study methodology follows the PRISMA guidelines. A comprehensive search was conducted using MEDLINE and EMBASE databases for RCTs with ES in patients with SOD. The primary outcome assessed was the improvement of abdominal pain after ES/sham. A random effects model was used to calculate pooled estimates for each outcome of interest. RESULTS: Of the initial 55 studies, 23 were screened and thoroughly reviewed. The final analysis included 3 studies. 340 patients (89.7% women) with SOD were included. All patients had a cholecystectomy. Most included patients had SOD type II and III. The pooled rate of technical success of ERCP was 100%. The average clinical success rate was 50%. The pooled cumulative rate of overall AEs related to all ERCP procedures was 14.6%. In the sensitivity analysis, only one study significantly affected the outcome or the heterogeneity. CONCLUSION: ES appears no better than placebo in patients with SOD type III. Sphincterotomy could be considered in patients with SOD type II and elevated SO basal pressure.

Does endoscopic sphincterotomy contribute to the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis after endoscopic biliary stenting for malignant biliary obstruction? A multicenter prospective cohort study.

BACKGROUND: There is no consensus on the necessity of endoscopic sphincterotomy (ES) to prevent post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) after endoscopic stenting in patients with malignant biliary obstruction. We investigated the incidence of PEP after endoscopic biliary stenting for malignant biliary obstruction with or without ES in a multicenter prospective cohort study. METHODS: We enrolled 807 patients who underwent endoscopic biliary stenting for malignant biliary obstruction with a native papilla at 36 hospitals between April 2017 and March 2018. The incidence of PEP in patients with or without ES was compared for subgroups based on stent type, placement method, and patient background. Univariate and multivariate analysis was performed to investigate the incidence of PEP in all stenting patients. RESULTS: Plastic and metal stents (MS) were inserted in 598 and 209 patients, respectively. The incidence of PEP in patients with or without ES was 7.9% and 7.4%, respectively among all stenting patients. The incidences of PEP with or without ES in plastic stent insertion patients, patients with MS insertion, stent insertions across the papilla, stent insertions across the papilla in patients without main pancreatic duct obstruction, and fully covered MS insertions across the papilla were compared. There was no overall significant difference in the incidence of PEP between those with or without ES. Multivariate logistic regression analysis for the incidence of PEP in all stenting patients revealed obstruction of the main pancreatic duct at the pancreatic head and epinephrine spraying on the papilla were significant factors; there was no significant difference in the incidence of PEP between patients with or without ES. CONCLUSION: Endoscopic sphincterotomy may not contribute to the prevention of PEP after endoscopic biliary stenting for malignant biliary obstruction, even in cases of insertion with a fully covered MS across the papilla.

The efficacy and safety of laparoscopic common bile duct exploration and cholecystectomy for the treatment of difficult common bile duct stones combined with gallstones: a multicenter retrospective study.

PURPOSE: To analyze the benefits of laparoscopic common bile duct exploration and laparoscopic cholecystectomy (LCBDE + LC) versus endoscopic retrograde cholangiopancreatography and/or endoscopic sphincterotomy following laparoscopic cholecystectomy (ERCP/EST + LC) for difficult common bile duct stones combined with gallstones. METHODS: A retrospective analysis of consecutive patients with difficult common bile duct stones combined with gallstones in three hospitals from January 2016 to January 2021 was performed. RESULTS: ERCP/EST + LC contributed to reducing postoperative drainage time. However, LCBDE + LC showed a higher rate of complete clearance, along with lower postoperative hospital stays, expenses and incidence of postoperative hyperamylasemia, pancreatitis, re-operation and recurrence. In addition, LCBDE + LC showed safe and feasible performance in the elderly and patients with previous upper abdominal surgery. CONCLUSION: It is an effective and safe method for LCBDE + LC for difficult common bile duct stones combined with gallstones.

Long-term outcomes of endoscopic papillary large-balloon dilation (12-15 mm) with or without limited sphincterotomy for removal of bile duct stones.

BACKGROUND: Limited endoscopic sphincterotomy with large balloon dilation (ES-LBD) and endoscopic papillary large-balloon dilation (EPLBD) have been proven safe and effective for removal of bile duct stones. However, the long-term outcomes are not clear. The aim of this study was to assess the long-term outcomes of EPLBD (12-15 mm) with or without limited sphincterotomy for removal of common bile duct (CBD) stones. METHODS: Patients with EPLBD or ES-LBD referred for the removal of bile-duct stones between June 2008 and August 2020 were retrospectively reviewed. Complete stone clearance, endoscopic retrograde cholangiopancreatography (ERCP)-related adverse events, and late biliary complications during long-term follow-up were analyzed. RESULTS: Basic patient characteristics were not significantly different between the groups that underwent EPLBD (n = 168) and ES-LBD (n = 57). EPLBD compared with ES-LBD resulted in similar outcomes in terms of overall successful stone removal (99.4% vs. 100%, P = 1.00) and ERCP-related adverse events (7.7% vs. 5.3%, P = 0.77). The mean duration of the follow-up were 113.6 months and 106.7 months for patients with EPLBD and ES-LBD, respectively (P = 0.13). There was no significant difference between EPLBD and ES-LBD in the incidence of stone recurrence [20 (11.9%) vs. 9 (15.8%); P = 0.49]. Multivariate analysis showed that a diameter of CBD ≥ 15 mm (OR = 3.001; 95% CI: 1.357-6.640; P = 0.007) was an independent risk factor for stone recurrence. CONCLUSIONS: The application of a large balloon (12-15 mm) via EPLBD is an effective and safe alternative to ES-LBD for extraction of large CBD stones. Endoscopic sphincterotomy prior to EPLBD may be unnecessary. A diameter of CBD ≥ 15 mm is a risk factor of stone recurrence.

Urgent and emergency endoscopic retrograde cholangiopancreatography for gallstone-induced acute cholangitis and pancreatitis.

Urgent or emergency endoscopic retrograde cholangiopancreatography (ERCP) is indicated for gallstone-induced acute cholangitis and pancreatitis. The technique and optimal timing of ERCP depend on the disease state, its severity, anatomy, patient background, and the institutional situation. Endoscopic transpapillary biliary drainage within 24 h is recommended for moderate to severe acute cholangitis. The clinical outcomes of biliary drainage with nasobiliary drainage tube placement and plastic stent placement are comparable, and the choice is made on a case-by-case basis considering the advantages and disadvantages of each. The addition of endoscopic sphincterotomy (EST) is basically not necessary when performing drainage alone, but single-session stone removal following EST is acceptable in mild to moderate cholangitis cases without antithrombotic therapy or coagulopathy. For gallstone pancreatitis, early ERCP/EST are recommended in cases with impacted gallstones in the papilla. In some cases of gallstone pancreatitis, a gallstone impacted in the papilla has already spontaneously passed into the duodenum, and early ERCP/EST lacks efficacy in such cases, with unfavorable findings of cholangitis or cholestasis. If it is difficult to diagnose the presence of gallstones impacted in the papilla on imaging, endoscopic ultrasonography can be useful in determining the indication for ERCP.

Does early application of needle-knife sphincterotomy (NKS) in patients with difficult biliary cannulation increase the risk of postERCP pancreatitis? A single centre study.

Objective: To determine that early needle-knife sphincterotomy does not increase post-ERCP pancreatitis in patients with difficult biliary cannulation as compared to standard cannulation. Method: This prospective single-centre cohort study was carried out at Pak Emirates Military Hospital from January 2021 to June 2021. Patients requiring ERCP were enrolled in the study (according to inclusion and exclusion criteria) and were subsequently allotted different groups according to the technique used for deep biliary cannulation. Qualitative data was analysed using frequencies and chi square statistics whereas, quantitative data was analysed using mean±SD and one way ANOVA test. Result: The cohort included 114 patients with 52.6% male patients and predominance of relatively younger age group (31-45 years). The most common indication for ERCP was choledocholithiasis (36%) with an overall technical success rate of 96%. Deep cannulation was achieved either through standard cannulation (56%), double guidewire and/or pancreatic stent assisted (10.5%), use of early Needle-Knife Sphincterotomy (19%), NKS as a last resort (3.5%) or Transpancreatic Stenting and/or combined sphincterotomy (6%). Pancreatitis as a complication occurred in 4(3.5%) patients, bleeding in 2(1.8%), on-table desaturation in 2(1.8%) and perforation in 1(0.9%) patient. The occurrence of pancreatitis was only related significantly to inadvertent PD cannulation through univariate and logistic regression analysis whereas, multiple cannulations (>5), gender, age, classification of papilla and the use of early NKS had no impact on pancreatitis or the occurrence of other complications. Conclusion: NKS is an effective and safe modality for deep biliary cannulation and achieving technical success where cannulation is deemed difficult and does not increase the risk of PEP if done by experienced endoscopists in high volume centres.

Risk of Pancreatitis Following Biliary Stenting With/Without Endoscopic Sphincterotomy: A Randomized Controlled Trial.

BACKGROUND & AIMS: The efficacy of endoscopic sphincterotomy (ES) before endoscopic transpapillary biliary drainage in preventing post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) has not been established. The aim of this study was to evaluate the effect of performing ES before biliary stent/tube placement on the occurrence of PEP. METHODS: Three hundred seventy patients with biliary stricture requiring endoscopic biliary stenting were enrolled and randomly allocated to the ES group (n = 185) or non-ES group (n = 185). All participants were followed up for 30 days after the procedure. The data and occurrence of adverse events were prospectively collected. The primary outcome measure of this study was the incidence of PEP within 2 days of initial transpapillary biliary drainage. Secondary outcome measures were the incidence of other adverse events related to biliary stent/tube placement. RESULTS: PEP occurred in 36 patients (20.6%) in the non-ES group and in 7 patients (3.9%) in the ES group (P < .001). The difference in the incidence of PEP between the 2 groups in the per-protocol population was 16.7% (95% confidence interval, 10.1%-23.3%), which was not within the noninferiority margin of 6%. Except for bleeding, the incidences of other adverse events were not significantly different between the groups. CONCLUSION: ES before endoscopic biliary stenting could have the preventive effect on the occurrence of PEP in patients with biliary stricture. University Hospital Medical Information Network Number, UMIN000025727.University Hospital Medical Information Network Clinical Trial Registry URL: https://www.umin.ac.jp/ctr/index.htm.

Endoscopic sphincterotomy and endoscopic biliary stenting do not affect the sensitivity of transpapillary forceps biopsy for the diagnosis of bile duct adenocarcinoma.

BACKGROUND: The pathological evaluation of tissues with cholangitis is considered difficult, which can often occur after endoscopic sphincterotomy (EST) and endoscopic biliary stenting (EBS). This study aimed to evaluate the influence of a history of EST and EBS on the sensitivity of transpapillary forceps bile duct biopsy (TB) for bile duct adenocarcinoma. METHODS: This retrospective study included consecutive cases of bile duct adenocarcinoma in which TB was performed before July 2020 until the number exceeded that required to support statistical and noninferiority analyses of the sensitivity of TB between patients with and without each variable. The incidence of postprocedural adverse events related to each factor was also investigated. RESULTS: Overall, 280 samples were required in each group, and 437 subjects (792 samples) were included. The sensitivity of TB was 63.6% for the subjects and 59.6% for the biopsy samples. For the biopsy samples, the sensitivity did not differ significantly between samples from patients with and without a history of EST (59.1% vs. 58.9%, P = 0.952) and EBS (62.1% vs. 55.4%, P = 0.065). The sensitivity was significantly higher for samples from patients with jaundice (67.9% vs. 57.0%, P = 0.008). There were significantly fewer procedure-related adverse events in patients with a history of EST (10.8% vs. 19.0%, P = 0.017) and EBS (12.0% vs. 21.7%, P = 0.005). CONCLUSIONS: A history of EST or EBS did not influence sensitivity of TB but significantly decreased the incidence of adverse events. To safely and reliably perform TB to diagnose bile duct adenocarcinoma, planning, including for EST and EBS, is necessary.

Biliary Sphincterotomy Alone versus Biliary Stent with or without Biliary Sphincterotomy for the Management of Post-Cholecystectomy Bile Leak: A Systematic Review and Meta-Analysis.

BACKGROUND: Endoscopic therapy with endoscopic retrograde cholangiopancreatography is considered the first-line treatment in the management of post-cholecystectomy bile leak (PCBL). Currently, there is no consensus on the most effective endoscopic intervention for PCBL. Hence, we performed a systematic review and meta-analysis to compare the effectiveness and safety of the two interventional groups (biliary sphincterotomy [BS] alone vs. biliary stent ± BS) in management of PCBL. METHODS: We conducted a comprehensive search of multiple electronic databases and conference proceedings (from inception through January 2021). The primary outcome was to compare the pooled rate of clinical success between the 2 groups. The secondary outcome was to estimate the pooled rate of adverse events. RESULTS: The pooled rate of clinical success with BS alone (5 studies, 299 patients) was 88% (95% confidence interval (CI): 84-92%, I2: 0%) and for biliary stent ± BS (5 studies, 864 patients) was 97% (CI: 93-100%, I2: 79%). The rate of clinical success in biliary stent ± BS group was significantly higher than BS alone group (OR: 3.91 95% CI: 2.29-6.69, p < 0.001, I2: 13%). The rate of adverse events was numerically lower in biliary stent ± BS group compared to BS alone (3 studies; OR: 0.65 95% CI: 0.41-1.03, p = 0.07) without statistical significance. Low heterogeneity was noted in the analysis. CONCLUSIONS: Biliary stent ± BS is more effective in endoscopic management of PCBL compared to BS alone. This may be related to inter-endoscopist variation in completeness of sphincterotomy and post-sphincterotomy edema, which can influence the preferential trans-papillary flow of bile.

Diagnostic value of endoscopic retrograde cholangiopancreatography and therapeutic value of endoscopic sphincterotomy in dogs with suspected hepatobiliary disorders.

BACKGROUND: Conventional diagnostic methods have some limitations in diagnosing specific causes of canine hepatobiliary disorders. In the evaluation of the hepatobiliary system in dogs, ultrasonography (US) is the first imaging method of choice. Nonetheless, endoscopic retrograde cholangiopancreatography (ERCP) has also been proven to be a practicable technique for evaluating canine hepatobiliary (endoscopic retrograde cholangiography, ERC) and pancreatic duct (endoscopic retrograde pancreatography, ERP) disorders, providing additional therapeutic options by sphincterotomy (EST). To date, the efficacy and safety of diagnostic and therapeutic ERCP has not been evaluated in veterinary medicine literature. The present study sought to report complications and outcomes of dogs undergoing ERCP and EST, and to assess the usefulness of diagnostic ERCP by comparing the findings of US, ERCP and histopathological findings in liver and pancreas. RESULTS: This retrospective case series comprises data collected from 15 dogs that underwent successful ERC/ERCP. Nine dogs underwent EST following ERC. US and ERC were best in agreement when assessing the common bile duct. In case of disagreement between the modalities, the ERC findings of the ductal structures were in line with the available pathology findings more often than the US findings, whereas the opposite was noted for the gallbladder. The technical success rates were 88.2% for ERC, 66.7% for ERP, and 81.8% for EST, with no major complications during or immediately after the procedure. Immediate bile flow after EST was recorded in 7/9 dogs but only four showed coinciding clinical and laboratory improvement and four dogs were euthanized within 1-6 days after EST. CONCLUSIONS: US remains a valuable initial diagnostic imaging method for hepatobiliary disorders and allows good assessment of the gallbladder. ERC can serve as a complementary procedure for diagnostic assessment of the hepatobiliary duct disorders. However, in order to improve the outcomes of EST, careful selection of patients for the procedure would require more advanced diagnostic imaging of the hepatobiliary area.

Endoscopic endoclip papilloplasty preserves sphincter of oddi function.

BACKGROUND: Endoscopic sphincterotomy (EST) can destroy sphincter of Oddi (SO) structure and function. The purpose of this study was to assess the feasibility of endoscopic endoclip papilloplasty (EEPP) in restoring SO function after EST. METHODS: Seven 26-week-old domestic pigs were divided into control and EEPP groups. Necropsy and haematoxylin-eosin staining plus anti-α-smooth muscle actin (α-SMA) staining of papilla and sphincter of Oddi manometry (SOM) were conducted in animals at three independent time points. RESULTS: EST and EEPP were safely performed in all 7 pigs without serious adverse events. For primary outcome, compared to the controls, EEPP generated smaller dilation and less inflammation. Fibrous repair of the papilla was observed at 24 weeks after EEPP. For secondary outcome, in the control group, SO basal pressure (17.25 ± 18.14 to 5.50 ± 0.71 mmHg), SO contraction amplitude (46.00 ± 19.20 to 34.50 ± 48.79 mmHg), peak (4.50 ± 4.04 to 1.50 ± 2.12) and frequency (3.05 ± 3.29 to 1.41 ± 2.19/min) were reduced after EST. Further reductions to almost 0 of these SOM parameters were observed 3 weeks later, including common bile duct pressure and SO contraction period. In contrast, in the EEPP group, these manometric data were recovered to pre-EST levels, including CBD pressure (11.5 ± 7.31 vs 11 ± 2.16 mmHg), SO pressure (17.50 ± 17.75 vs 18.20 ± 21.39 mmHg) and SO contraction amplitude (53.67 ± 21.54 vs 60.00 ± 36.08 mmHg). However, no significant differences were observed between control and EEPP groups by Student t test. CONCLUSIONS: In this porcine study, EEPP accelerated and improved papillary healing after EST, further preserved SO function.

Direct oral anticoagulants increase bleeding risk after endoscopic sphincterotomy: a retrospective study.

BACKGROUND: Bleeding can be a serious adverse event of endoscopic sphincterotomy (EST). However, the risk of EST bleeding between direct oral anticoagulant (DOAC) users and those who received no antithrombotic agents has not been clarified. This study analyzed the risk factors for bleeding after EST in patients on DOAC and evaluated the Japan Gastroenterological Endoscopy Society (JGES) guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment. METHODS: We retrospectively analyzed 524 patients treated with EST who received DOAC or no antithrombotic drug from May 2016 to August 2019. We investigated the risk factors for bleeding. DOAC was typically discontinued for ≤ 1-day based on the JGES guideline. Although DOAC therapy recommenced the next morning after EST in principle, the duration of DOAC cessation and heparin replacement were determined by the attending physician based on each patient's status. RESULTS: The number of patients on DOAC (DOAC group) and those not on antithrombotic drug (no-drug group) was 42 (8.0%) and 482 (92.0%), respectively. DOAC was discontinued for ≤ 1-day in 17 (40.0%) patients and for > 1-day in 25 (60.0%). Of the 524 patients, 21 (4.0%) had EST bleeding. The bleeding rate was higher in the DOAC group (14.0%) (p = 0.004). Multivariate analysis showed that bleeding occurred more frequently in patients on DOAC (odds ratio [OR] 3.95, 95% confidence interval [CI] 1.37-11.4, p = 0.011), patients with low platelet counts (< 100,000/µl) (OR 6.74, 95% CI 2.1-21.6, p = 0.001), and elderly patients (> 80 years old) (OR 3.36, 95%CI 1.17-9.65, p = 0.024). CONCLUSIONS: DOAC treatment, low platelet count, and old age (> 80 years old) are risk factors for EST bleeding. Although the bleeding incidence increased in patients on DOAC who received antithrombotic therapy according to the JGES guidelines, successful hemostasis was achieved with endoscopy in all cases, and no thrombotic events occurred after cessation of DOAC. Thus, the JGES guidelines are acceptable.