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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 ).

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.

BackgroundNeedle knife papillotomy (NKP) and fistulotomy (NKF) are the two most commonly used rescue techniques for patients with difficult biliary cannulation (DBC). Anatomy of the major duodenal papillae (MDP) influences the optimal precut technique for biliary access. However, comparative studies of the success and safety of NKP and NKF based on the anatomy of MDP have been scarce.MethodsPatients with intact MDPs for therapeutic endoscopic retrograde cholangio-pancreatography (ERCP) in our center were enrolled. Early needle knife precuts were uniformly applied to patients with DBC. Difficult MDPs were classified into one of five types based on their endoscopic anatomy. Each type of MDP was allocated to NKP or NKF treatment. Patients with types 1 and 2 papillae always received NKF, 3 and 4 received NKP, and 5 could receive either. The safety and efficacy were analyzed between NKP and NKF, and among different types of MDPs.ResultsA total of 188 out of 1674 patients undergoing ERCP satisfied the criteria for early precutting: 75 patients were assigned to the NKP group and 113 to the NKF group. The total initial success rate of biliary cannulation (ISRBC) of the precut techniques (both NKP and NKF) for patients with DBC was 91.5%. The ISRBC of patients of the NKP group was similar to that of the NKF group (90.7% vs 92.0%, P > 0.05). The ISRBC of the patients in the swollen MDP subgroup (96.1%) was higher than that of patients in the distorted MDP subgroup (81.8%, P = 0.030). The total and specific complications of the patients of the NKP group were similar to those of the NKF group (P > 0.05).ConclusionsNKP and NKF, as selected on the basis of MDP anatomy, are equally safe and highly efficient for patients with DBC to allow biliary cannulation. Patients with swollen MDPs had a higher ISRBC than patients with distorted MDPs. Selecting a precut method based on MDP anatomy is an effective and safe strategy for patients with DBC.

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.

BackgroundThere 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.MethodsWe 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.ResultsPlastic 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.ConclusionEndoscopic 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.

BackgroundEndoscopic 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.MethodsERCP 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.ResultsA 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.ConclusionEPBD 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.

ObjectiveRoutine urgent endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic biliary sphincterotomy (ES) does not improve outcome in patients with predicted severe acute biliary pancreatitis. Improved patient selection for ERCP by means of endoscopic ultrasonography (EUS) for stone/sludge detection may challenge these findings.DesignA multicentre, prospective cohort study included patients with predicted severe acute biliary pancreatitis without cholangitis. Patients underwent urgent EUS, followed by ERCP with ES in case of common bile duct stones/sludge, within 24 hours after hospital presentation and within 72 hours after symptom onset. The primary endpoint was a composite of major complications or mortality within 6 months after inclusion. The historical control group was the conservative treatment arm (n=113) of the randomised APEC trial (Acute biliary Pancreatitis: urgent ERCP with sphincterotomy versus conservative treatment, patient inclusion 2013–2017) applying the same study design.ResultsOverall, 83 patients underwent urgent EUS at a median of 21 hours (IQR 17–23) after hospital presentation and at a median of 29 hours (IQR 23–41) after start of symptoms. Gallstones/sludge in the bile ducts were detected by EUS in 48/83 patients (58%), all of whom underwent immediate ERCP with ES. The primary endpoint occurred in 34/83 patients (41%) in the urgent EUS-guided ERCP group. This was not different from the 44% rate (50/113 patients) in the historical conservative treatment group (risk ratio (RR) 0.93, 95% CI 0.67 to 1.29; p=0.65). Sensitivity analysis to correct for baseline differences using a logistic regression model also showed no significant beneficial effect of the intervention on the primary outcome (adjusted OR 1.03, 95% CI 0.56 to 1.90, p=0.92).ConclusionIn patients with predicted severe acute biliary pancreatitis without cholangitis, urgent EUS-guided ERCP with ES did not reduce the composite endpoint of major complications or mortality, as compared with conservative treatment in a historical control group.Trial registration number ISRCTN15545919.

Background When cannulation is challenging during endoscopic retrograde cholangiopancreatography (ERCP), and the standard guidewire technique with sphincterotomy is unsuccessful, alternative cannulation techniques can be used to access the biliary tree. The purpose of this study was to compare the incidence of adverse events and cannulation success rates between transpancreatic sphincterotomy (TPS) and precut sphincterotomy (PCS). Methods Data from the Swedish Registry for Gallstone Surgery and ERCP (GallRiks), collected from 2011 to 2022, were analyzed. A total of 105,303 ERCP procedures were recorded in GallRiks during the study period. After exclusions, the study population consisted of 47,486 ERCP procedures. Of these, 4547 received PCS and 3273 received TPS. The remaining 39,666 ERCP procedures with conventional sphincterotomy served as the control group. The primary endpoints were successful cannulation and adverse events within 30 days. Results Successful cannulation was more frequent with the TPS technique than with the PCS technique (86.5% vs. 69.7%), but both groups had a lower cannulation rate than the control group (92.4%; OR-PCS 0.20, 95% CI 0.18–0.21; OR-TPS 0.58, 95% CI 0.52–0.64). The TPS group had a higher incidence of adverse events than the PCS group (24.1% vs. 18.8%) and both groups had a higher incidence of adverse events than the control group (15.5%; OR-PCS 1.25, 95% CI 1.15–1.36; OR-TPS 1.71, 95% CI 1.57–1.87). Adverse events for TPS were driven by a higher incidence of pancreatitis (10.5% vs. 6.4% vs. 4.5%; OR 2.53, 95% CI 2.23–2.86) and perforation (1.6% vs. 0.8% vs. 0.5%; OR 2.99, 95% CI 2.20–4.06) compared to both PCS and control. Conclusion TPS is more successful at cannulation than PCS; however, this success comes at a higher cost in terms of adverse events, particularly pancreatitis and perforation. Graphical abstract