BACKGROUND:Acute pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP), known as post-ERCP pancreatitis (PEP), is a major adverse event. Although risk factors for PEP incidence have been widely studied, factors associated with severe PEP remain unclear. AIM:To identify risk factors, including body composition, associated with severe PEP. METHODS:A retrospective cohort study was conducted in patients who underwent ERCP at two tertiary care centers in Japan between January 2013 and October 2021. PEP severity was defined according to the American Society of Gastrointestinal Endoscopy Workshop criteria (2010). Patients were divided into mild and moderate-to-severe groups. Body composition parameters, including skeletal muscle index, subcutaneous adipose tissue, and visceral adipose tissue (VAT), were assessed using CT. Multivariate analysis was performed to identify factors associated with severe PEP. RESULTS:Among 3087 patients who underwent ERCP for biliary disease, 85 (2.75%) developed PEP. VAT was significantly higher in the severe than mild group (132.7 vs. 80.1 cm2, p < 0.01). VAT > 95 cm2 was the only independent risk factor for severe PEP (OR 2.79, p = 0.04). CONCLUSION:VAT may be associated with severe PEP. ERCP should be performed with awareness of the increased risk of severe PEP in patients with high visceral adiposity.

Partially covered self-expandable metallic stents (PCSEMSs) used for endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) provide favorable patency and low migration risk; however, reintervention (RI) remains challenging. We retrospectively evaluated the outcomes of RI after EUS-HGS with PCSEMS placement in 108 patients with malignant biliary obstruction treated between January 2016 and December 2024. Causes of recurrent biliary obstruction (RBO), RI techniques, and post-RI outcomes were analyzed. The median age of patients was 77 years, with pancreatic cancer being the most common (n = 62). RBO occurred in 25 (23

BACKGROUND & AIMS:The optimal timing for direct endoscopic necrosectomy (DEN) after endoscopic ultrasound (EUS)-guided transmural drainage of symptomatic necrotizing pancreatitis remains unknown. We hypothesized that immediate DEN after EUS-guided drainage might reduce the time to disease resolution compared with a drainage-oriented step-up approach. METHODS:This study was a multicenter, open-label, superiority randomized trial (WONDER-01). Among patients who received EUS-guided treatment for symptomatic necrotizing pancreatitis, eligible patients were randomly assigned 1:1 to receive either immediate DEN or the drainage-oriented step-up approach. The primary endpoint was the time from randomization to clinical success, defined as a decrease in collection size to ≤3 cm and an improvement in inflammatory markers. RESULTS:Seventy patients were enrolled in this study: 33 in the immediate DEN arm and 37 in the step-up arm. Immediate DEN was associated with a shorter time to clinical success than the step-up approach (P = .009), with median times (95% confidence interval) of 29 (19-34) and 44 (38-52) days, respectively. All patients in the immediate DEN arm received DEN compared with 46% in the step-up approach arm, but the rates of procedure-related adverse events were comparable (24% vs 22%, respectively; P = .79). No significant differences were noted between the treatment arms in terms of technical success (100% vs 97%; P > .99) and mortality (12% vs 5.4%; P = .41). CONCLUSIONS:Compared with the step-up approach, immediate DEN after EUS-guided drainage of necrotizing pancreatitis reduced time to clinical success without increasing adverse outcomes but required more DEN procedures (ClinicalTrials.gov, NCT05451901).

Objectives: Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) for acute cholecystitis (AC) has a high technical and clinical success rate and is beneficial for patients’ quality of life due to internal fistula drainage, especially for high-risk surgical patients. Two drainage devices (plastic stent [PS] and lumen-apposing metal stent [LAMS]) are available; however, suitable drainage devices remain unclear. Methods: Between 2016 and 2026, 20 PS and 20 LAMS placement high-risk surgical AC were compared. Technical and clinical success rates, the number of dilation cases for the puncture route, procedure time, adverse events (AEs), and hospital stay were evaluated. Results: There was no significant difference in patients’ backgrounds, except for the number of percutaneous gallbladder drainage conversion cases (75% in PS group vs. 10% in LAMS group; P < 0.01). The shortest gallbladder diameter tended to be larger in the LAMS (30-mm) than in the PS group (25-mm; P = 0.052). Dilation of the puncture site was required in all PS cases. The technical and clinical success rates were 100% in both groups. EUS-GBD procedure time was significantly shorter in the LAMS group (7 min. vs. 21 min.; P < 0.01). The AEs occurrence rate was significantly higher in the PS group (40% vs. 5%; P = 0.02), which led to a significantly longer hospital stay in PS group (34-days vs. 10-days; P = 0.047). Conclusions: LAMS placement in EUS-GBD for high-risk surgical patients with AC was associated with a significantly shorter procedure time, shorter hospital stay, and lower occurrence of AEs. LAMS is a safe and useful device for EUS-GBD. Clinical Trial Registration UMIN000060137

Various self-expandable metallic stents (SEMS) have been developed to improve the patency of patients with malignant distal biliary obstruction (MDBO). This retrospective study aimed to evaluate SEMS characteristics associated with longer patency in initial SEMS placement for unresectable MDBO. Patients with unresectable MDBO identified in databases from four medical centers were analyzed. Patient background, SEMS type, and time to recurrent biliary obstruction (TRBO) were analyzed. The extracted variables were subjected to propensity score matching (PSM) to reduce selection bias. Between 2010 and 2025, 780 patients with MDBO were identified, 501 of whom met the inclusion criteria. In the multivariate analysis, 12-mm bore size, laser-cut SEMS, and 8-cm length SEMS were identified as independent significant factors contributing to TRBO. To confirm the utility of three significant factors, PSM analysis was performed on each. A total of 126 patients with 12- and 10-mm bore-size SEMS, 34 patients with laser-cut and braided SEMS, and 169 patients with 8-cm and < 8-cm length SEMS were compared. The hazard ratio of the 12-mm bore size SEMS was 0.65 (95

BACKGROUND:Endoscopic sphincterotomy plus balloon dilation (ESBD), which combines a small endoscopic sphincterotomy (EST) with endoscopic papillary balloon dilation (EPBD), has recently gained attention. AIMS:This study aimed to compare the clinical outcomes of ESBD and EST in the management of common bile duct stones (CBDSs). METHODS:We conducted a retrospective evaluation of 1067 patients who underwent ESBD or EST for the treatment of CBDSs (≤ 12 mm) between January 2017 and December 2024. The patients were divided into two groups on the basis of endoscopic management, and propensity-score matching generated 224 patient pairs to balance the group characteristics. RESULTS:The technical success rate was significantly higher in the ESBD group (96.8% vs. 91.0%, p = 0.015). Furthermore, the total number of endoscopic retrograde cholangiopancreatography sessions required for complete stone extraction was significantly lower in the ESBD group. Early adverse event (AE) and the incidence of bleeding were significantly lower in the ESBD group (2.6% vs. 9.8%, p = 0.002). The cumulative late AE were 10.7% and 14.2% in the ESBD and EST groups, respectively. CONCLUSION:ESBD for the management of CBDSs was more effective than EST, and no differences in long-term outcomes were observed during a relatively long follow-up period.

Malignant hilar biliary obstruction (MHBO) remains challenging for biliary decompression. Although endoscopic ultrasound-guided biliary drainage (EUS-BD) has emerged as an alternative to endoscopic retrograde cholangiopancreatography-guided BD (ERCP-BD), evidence regarding EUS-BD for MHBO is limited. Aims:To evaluate the efficacy and safety of EUS-BD for MHBO. Methods:This multicenter retrospective cohort study included patients with MHBO who underwent EUS-BD at 12 tertiary referral centers between 2012 and 2023. Technical success, clinical success, and procedure-related adverse events (AEs) were assessed. Multivariable analysis was performed to identify factors associated with clinical failure. Results:A total of 141 patients were included. EUS-BD was performed as primary drainage in 67 patients (47.5%) and as rescue drainage after prior ERCP-BD in 74 patients (52.5%); in rescue cases, the reported configurations represented only the EUS-BD component. The overall technical success rate was 98.5% (139/141). Clinical success was achieved in 87.1% (121/139). Among patients who achieved clinical success, the median time to recurrent biliary obstruction was 201 days. Procedure-related AE occurred in 15 patients (10.6%). Multivariable analysis identified Bismuth type IV strictures (odds ratio [OR], 5.89; 95% confidence interval [95% CI], 1.72-24.3) and EUS-BD drainage limited to one or two liver segments (OR, 5.11; 95% CI, 1.49-21.2) as factors associated with clinical failure. Conclusions:EUS-BD is a highly feasible and relatively safe option for BD of MHBO in both primary and rescue settings. Bismuth type IV strictures and EUS-BD drainage limited to one or two liver segments were associated with clinical failure. Trial Registration:N/A.

Background Endoscopic retrograde cholangiopancreatography (ERCP), a procedure to treat pancreaticobiliary disorders, is generally safe. However, adverse events (AEs) of post-ERCP pancreatitis (PEP) can occur, which can be fatal. Physicians performing ERCP can take measures to prevent PEP, including endoscopic pancreatic duct stents and pharmacological prophylaxis. Periprocedural aggressive hydration has been investigated for its potential for reducing PEP risk. This study aims to evaluate the efficacy and safety of periprocedural aggressive hydration plus intrarectal diclofenac versus standard hydration therapy plus intrarectal diclofenac in preventing PEP onset in Japanese patients. Methods This phase 3, multicenter, open-label, randomized controlled study is being conducted at an anticipated 27 sites in Japan. The study plans to enroll 780 adults (aged ≥ 18 years) who are scheduled to receive an ERCP procedure. Patients will be randomized 1:1 to the aggressive hydration or standard hydration group. Approximately 8 h prior to the ERCP procedure, patients in both groups will be administered the main infusion (≤ 1.5 mL/kg/h). The aggressive hydration group will receive a bolus of 500 mL Ringer’s solution at the start of the ERCP procedure (500 mL/h) followed by Ringer’s solution administered at 3mL/kg/h for 8 h. The standard hydration group will be administered Ringer’s solution at 1.5 mL/kg/h initiated at the start of the ERCP procedure and continuing for 9 h. Within 30 min of completing the ERCP procedure, patients in both groups will receive intrarectal diclofenac sodium (standard, 50 mg; patients weighing < 50 kg or aged ≥ 80 years, 25 mg). The primary endpoint is the incidence of PEP (serum amylase ≥ 400 U/I after ERCP completion and persistent abdominal pain for ≥ 24 h). Secondary endpoints include the incidence of PEP by severity, the incidence of hyperamylasemia (increase in amylase ≥ 400 U/I), and the incidence of infusion-related AEs. AEs will be monitored throughout the study. Discussion This study aims to clarify whether aggressive hydration reduces PEP incidence versus standard hydration, and to compare PEP incidence by severity, and the incidence of hyperamylasemia and infusion-related AEs. Safety will be determined in both groups. Trial registration: Japan Registry of Clinical Trials (jRCT: s041230145; registered February 6, 2024; https://jrct.mhlw.go.jp/latest-detail/jRCTs041230145)