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It remains unclear whether urgent endoscopic retrograde cholangiopancreatography (ERCP) with biliary sphincterotomy improves the outcome of patients with gallstone pancreatitis without concomitant cholangitis. We did a randomised trial to compare urgent ERCP with sphincterotomy versus conservative treatment in patients with predicted severe acute gallstone pancreatitis. In this multicentre, parallel-group, assessor-masked, randomised controlled superiority trial, patients with predicted severe (Acute Physiology and Chronic Health Evaluation II score ≥8, Imrie score ≥3, or C-reactive protein concentration >150 mg/L) gallstone pancreatitis without cholangitis were assessed for eligibility in 26 hospitals in the Netherlands. Patients were randomly assigned (1:1) by a web-based randomisation module with randomly varying block sizes to urgent ERCP with sphincterotomy (within 24 h after hospital presentation) or conservative treatment. The primary endpoint was a composite of mortality or major complications (new-onset persistent organ failure, cholangitis, bacteraemia, pneumonia, pancreatic necrosis, or pancreatic insufficiency) within 6 months of randomisation. Analysis was by intention to treat. This trial is registered with the ISRCTN registry, ISRCTN97372133. Between Feb 28, 2013, and March 1, 2017, 232 patients were randomly assigned to urgent ERCP with sphincterotomy (n=118) or conservative treatment (n=114). One patient from each group was excluded from the final analysis because of cholangitis (urgent ERCP group) and chronic pancreatitis (conservative treatment group) at admission. The primary endpoint occurred in 45 (38%) of 117 patients in the urgent ERCP group and in 50 (44%) of 113 patients in the conservative treatment group (risk ratio [RR] 0·87, 95% CI 0·64–1·18; p=0·37). No relevant differences in the individual components of the primary endpoint were recorded between groups, apart from the occurrence of cholangitis (two [2%] of 117 in the urgent ERCP group vs 11 [10%] of 113 in the conservative treatment group; RR 0·18, 95% CI 0·04–0·78; p=0·010). Adverse events were reported in 87 (74%) of 118 patients in the urgent ERCP group versus 91 (80%) of 114 patients in the conservative treatment group. In patients with predicted severe gallstone pancreatitis but without cholangitis, urgent ERCP with sphincterotomy did not reduce the composite endpoint of major complications or mortality, compared with conservative treatment. Our findings support a conservative strategy in patients with predicted severe acute gallstone pancreatitis with an ERCP indicated only in patients with cholangitis or persistent cholestasis. The Netherlands Organization for Health Research and Development, Fonds NutsOhra, and the Dutch Patient Organization for Pancreatic Diseases.

BackgroundEndoscopic 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.ObjectiveTo compare endoscopic sphincterotomy to no sphincterotomy prior to FCSEMS placement.DesignThis 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.ResultsBetween 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.ConclusionThis 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 numberNL5130.

Periampullary diverticulum (PAD) often increases the difficulty of ERCP operation, and there is no standardized treatment strategy. This study compared the efficacy of “small incision + large balloon dilation (EST + EPBD)” with traditional ERCP. 111 patients with PAD complicated with choledocholithiasis were randomly divided into experimental group ( n  = 55, EST < 5 mm + EPBD) and control group ( n  = 56, conventional EST/EPBD). The primary endpoints were one-time stone clearance and adverse event rate, while secondary endpoints included operative time and common bile duct pressure. One-time stone clearance rate: test group 98.1% vs. control group 87.5% ( P  = 0.029) • Mean operation time: 24 ± 9 min vs. 31 ± 11 min ( P  < 0.001) • CBD pressure 6 days after surgery: 11.5 ± 2.3 vs. 8.5 ± 1.6 cm H₂O ( P  < 0.001) • Incidence of postoperative pancreatitis: 3.6% vs. 10.7% ( P  = 0.206). EST + EPBD can significantly improve stone removal efficiency, shorten operation time, and may improve long-term prognosis by preserving Oddi sphincter function.

Background The first-line treatment for common bile duct stones (CBDS) is endoscopic transpapillary stone removal, typically performed using either endoscopic sphincterotomy (EST) or endoscopic papillary balloon dilation (EPBD). However, EST is associated with risks of bleeding and perforation, while EPBD carries a significant risk of post-procedural pancreatitis. Recently, a combined approach involving minimal EST followed by EPBD (ESBD) has been reported to mitigate these drawbacks, offering potentially safer and more effective outcomes. Nevertheless, no prospective study has adequately evaluated the utility of ESBD, as prior studies were mainly observational or limited by small sample sizes. Therefore, we designed a randomized controlled trial to investigate whether ESBD is superior to EST for the treatment of small CBDS. Methods This study is a multicenter, randomized, open-label, parallel-group trial; outcome assessors will not be blinded, but objective predefined criteria will be used to minimize bias. Eligible participants will include patients aged 18 years or older diagnosed with CBDS who require endoscopic stone removal, with eligibility confirmed via imaging modalities. After confirming eligibility, patients will be randomly assigned in a 1:1 ratio to either the ESBD group or the EST group. In the ESBD group, a minimal sphincterotomy will first be performed, followed by balloon dilation for stone extraction. In the EST group, a medium incision extending beyond the hooding fold will be performed prior to stone extraction. The primary endpoint is the incidence of procedure-related adverse events, including pancreatitis, bleeding, and perforation. Secondary endpoints include technical success rate, clinical success rate, procedure time, need for lithotripsy, and stone recurrence rate. Discussion This study is the first multicenter, randomized controlled trial to prospectively evaluate the efficacy and safety of ESBD for the treatment of small CBDS. The findings are expected to determine whether ESBD can serve as a new standard therapeutic option compared with conventional EST. Trial registration Japan Registry of Clinical Trials: jRCT1040250008. Registered on 21 April 2025. ( https://jrct.mhlw.go.jp/en-latest-detail/jRCT1040250008 ).

Background In Japan and Europe, a retrieval basket is generally used for endoscopic extraction of bile duct stones, while in the US, a retrieval balloon is mainly used. However, the efficacies of these two devices have not been previously compared. Therefore, the present multicenter, prospective, randomized study was performed to compare the efficacies of these two devices for endoscopic biliary stone extraction. Methods This study was designed as a non-inferiority study in comparing a basket removal with a balloon removal. Six Japanese institutions participated in this study, which included 184 patients with bile duct stones < 11 mm in diameter with no limitation in the number of stones. The stones were identified and measured during ERCP, after which the patients were randomly assigned to undergo endoscopic stone extraction using either a basket catheter or a balloon catheter. The primary end point was the rate of complete removals of stones within 10 min, and the secondary end point was the rate of procedure-related complications. Results There were 91 patients in the basket group and 93 in the balloon group. The rate of successful stone extraction within 10 min was 81.3 % (74/91) in the basket group and 83.9 % (78/93) in the balloon group ( p  = 0.7000). The complication rate was 6.6 % in the basket group and 11.8 % in the balloon group ( p  = 0.3092). Complications included bleeding, pancreatitis, and cholangitis. Conclusions Basket and balloon catheters showed similar efficacies for endoscopic biliary stone extraction when stone size is 11 mm or smaller.

Background The ideal method for managing concomitant gallbladder stones and common bile duct (CBD) stones is debatable. The currently preferred method is two-stage endoscopic stone extraction followed by laparoscopic cholecystectomy (LC). This prospective randomized trial compared the success and cost effectiveness of single- and two-stage management of patients with concomitant gallbladder and CBD stones. Methods Consecutive patients with concomitant gallbladder and CBD stones were randomized to either single-stage laparoscopic CBD exploration and cholecystectomy (group 1) or endoscopic retrograde cholangiopancreatography (ERCP) for endoscopic extraction of CBD stones followed by LC (group 2). Success was defined as complete clearance of CBD and cholecystectomy by the intended method. Cost effectiveness was measured using the incremental cost-effectiveness ratio. Intention-to-treat analysis was performed to compare outcomes. Results From February 2009 to October 2012, 168 patients were randomized: 84 to the single-stage procedure (group 1) and 84 to the two-stage procedure (group 2). Both groups were matched with regard to demographic and clinical parameters. The success rates of laparoscopic CBD exploration and ERCP for clearance of CBD were similar (91.7 vs. 88.1 %). The overall success rate also was comparable: 88.1 % in group 1 and 79.8 % in group 2 ( p  = 0.20). Direct choledochotomy was performed in 83 of the 84 patients. The mean operative time was significantly longer in group 1 (135.7 ± 36.6 vs. 72.4 ± 27.6 min; p  ≤ 0.001), but the overall hospital stay was significantly shorter (4.6 ± 2.4 vs. 5.3 ± 6.2 days; p  = 0.03). Group 2 had a significantly greater number of procedures per patient ( p  < 0.001) and a higher cost ( p  = 0.002). The two groups did not differ significantly in terms of postoperative wound infection rates or major complications. Conclusions Single- and two-stage management for uncomplicated concomitant gallbladder and CBD stones had similar success and complication rates, but the single-stage strategy was better in terms of shorter hospital stay, need for fewer procedures, and cost effectiveness.

In cases of difficult biliary cannulation, transpancreatic sphincterotomy (TPS) can be an alternative approach of biliary access. However, its success and safety profile have not been studied in detail. A systematic review and meta-analysis were performed to study the overall cannulation success and adverse events of TPS. These outcomes were also compared to other advanced cannulation methods. A systematic literature search was conducted to find all relevant articles containing data on TPS. Successful biliary cannulation and complications rates [post-ERCP pancreatitis (PEP), bleeding, and perforation rates] were compared in the pooled analyses of prospective comparative studies. The overall outcomes were calculated involving all studies on TPS. TPS was superior compared to needle-knife precut papillotomy (NKPP) and the double-guidewire method (DGW) regarding cannulation success (odds ratio [OR] 2.32; 95% confidence interval [CI] 1.37–3.93; and OR 2.72; 95% CI 1.30–5.69, respectively). The rate of PEP did not differ between TPS and NKPP or DGW; however, TPS (only retrospective studies were available for comparison) proved to be worse than needle-knife fistulotomy in this regard (OR 4.62; 95% CI 1.36–15.72). Bleeding and perforation rates were similar among these advanced techniques. There were no data about long-term consequences of TPS. The biliary cannulation rate of TPS is higher than that of the other advanced cannulation techniques, while the safety profile is similar to those. However, no long-term follow-up studies are available on the later consequences of TPS; therefore, such studies are strongly needed for its full evaluation.

Up to 60% of patients with common bile duct stone (CBDS) recurrence suffer from further recurrence after endoscopic retrograde cholangiopancreatography (ERCP). There are no effective methods to prevent recurrence in most patients. In this study, we aimed to assess the short-term and long-term efficacies of endoscopic papillary large balloon dilation (EPLBD) for the management of recurrent CBDS in a randomized controlled trial. Consecutive patients with recurrent CBDS were eligible and randomly assigned in a 1:1 ratio to the EPLBD group or the control group. The primary outcome was the CBDS recurrence rate within 2 years after ERCP. The analysis followed the intention-to-treat principle. From 2014 to 2021, 180 patients with recurrent CBDS were included, with 90 in each group. All patients underwent complete CBDS clearance by 1 or several sessions of ERCP. The rate of complete clearance in 1 session was significantly higher with EPLBD treatment (95.6% vs 85.6%, P = 0.017). During the follow-up, the CBDS recurrence rate within 2 years was significantly lower in the EPLBD group than in the control group (21.1% [19/90] vs 36.7% [33/90], relative risk 0.58, 95% confidence interval 0.36-0.93, P = 0.021). At a median follow-up of approximately 56 months, CBDS recurrence was found in 34.4% of the patients (31/90) in the EPLBD group and 51.1% (46/90) in the control group (hazard ratio 0.57, 95% confidence interval 0.36-0.89, P = 0.012). Multiple recurrences (≥2) were also decreased in the EPLBD group (4.4% vs 18.9%, P = 0.020). During the long-term follow-up, nearly half of the patients with recurrent CBDS experienced stone recurrence after traditional ERCP. Our study was the first to show that EPLBD effectively reduced the recurrence of CBDS.

INTRODUCTION:The morphology of the major papilla plays a crucial role in the selection of the cannulation method for the common bile duct during endoscopic retrograde cholangiopancreatography. Nevertheless, there is limited evidence available that compares the efficacy and safety of cannulation approaches in certain papilla morphologies. The aim of this study was to assess the safety and effectiveness of 2 cannulation methods, including primary needle-knife fistulotomy (pNKF) and standard transpapillary (STP), in patients with long-size papilla.METHODS:A total of 260 patients with intact long-size papilla were enrolled and were randomly assigned to the pNKF or STP groups (n = 130 in each group). The primary endpoint was the rate of postendoscopic retrograde cholangiopancreatography pancreatitis. Biliary cannulation success rates, the duration of cannulation and the overall procedure, and the incidence of adverse events were also compared between the groups. All of the patients were hospitalized for at least 24 hours after the procedure.RESULTS:A total of 125 (96.2%) patients in the pNKF and 114 (87.7%) patients in the STP groups had successful primary biliary cannulation (P = 0.01) and were included in the final analysis. Postendoscopic retrograde cholangiopancreatography pancreatitis occurred in 11 patients in the STP group and 3 patients in the pNKF group (9.6% vs 2.4%, P = 0.02; number needed to treat [95% confidence interval] = 13.9 [7.5-83.2]). Moreover, compared with the pNKF, STP was associated with more cannulation attempts (3.4 vs 2.5, P < 0.001) and longer cannulation time (258 vs 187 seconds, P < 0.001).DISCUSSION:In patients with long-size papilla, pNKF is a safer, easier, and more efficient approach to gain primary biliary access than the STP technique.

Background Endoscopic retrograde cholangiopancreatography (ERCP) is an indispensable procedure for the management of pancreaticobiliary diseases. Post-ERCP pancreatitis (PEP) is the most common serious adverse event. One risk factor of PEP is difficulty achieving biliary access. The conventional ERCP technique involves the cannulation of the bile duct via the ampulla of Vater, followed by sphincter incision using electrocautery. Conventionally, if the standard method fails then, precut techniques have been utilized as an alternative means of gaining biliary access. The needle-knife fistulotomy (NKF) technique involves identifying the intra-duodenal segment of the bile duct and uses a needle knife to incise directly into the bile duct. This is done above and away from the natural office, thus minimizing thermal damage which may result in PEP. Our recent prospective study of 50 patients demonstrated the safety and feasibility of the NKF precut technique as a primary means of gaining biliary access. The next step is to conduct a randomized controlled trial to compare the efficacy and safety of initial NKF to the standard cannulation in a non-selective patient population undergoing ERCP. Methods A randomized control trial of 538 consecutive, non-selective patients with pancreaticobiliary disease undergoing ERCP at a tertiary care center in Kingston, Ontario, Canada, will be conducted. Patients will be randomized to one of two treatment groups, standard cannulation or NKF. The primary outcome of the study will be the incidence of PEP. Secondary outcomes will include rate of successful cannulation of the common bile duct (CBD), time to successful cannulation, total procedure time, difficulty of cannulation, and incidence of complications. Discussion This RCT will yield important answers regarding the efficacy and safety of initial NKF to the standard cannulation in a non-selective patient population undergoing ERCP. The results of our study could alter ERCP practices and outcomes if NKF is shown to reduce PEP risk. Trial registration ClinicalTrials.gov NCT04559867 . Registered on September 23, 2020