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
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.
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)
Background/Aims This study evaluated the feasibility and clinical outcomes of a novel tapered and flared, fully covered, self-expandable metal stent (TF-FCSEMS) for unresectable malignant distal biliary obstruction (UMDBO). Methods This multicenter retrospective study included 40 patients who underwent transpapillary placement of a TF-FCSEMS (10-mm cylindrical body with an 8-mm tapered distal end) for UMDBO between May 2023 and July 2024. The primary outcome was time to recurrent biliary obstruction (TRBO). Secondary outcomes included technical and clinical successes, adverse events (AEs), and overall survival. Results Technical and clinical success rates were 100% and 98%, respectively. During a median follow-up period of 271 days, recurrent biliary obstruction (RBO) occurred in 10 (26%) of the 39 patients who achieved clinical success. The median TRBO was 539 days (95% confidence interval, 389–not reached), and the non-RBO rates at 3, 6, and 12 months were 94%, 71%, and 61%, respectively. Symptomatic stent migration occurred in 2 patients (5.1%), while asymptomatic migration was observed in 3 (7.7%). Post-endoscopic retrograde cholangiopancreatography pancreatitis occurred in four patients (10%). Non-occlusion cholangitis developed in five (13%) patients, mostly with tumor-related duodenal stenosis. All AEs were managed conservatively or endoscopically. Conclusions TF-FCSEMS appears to be a feasible and acceptable treatment option for UMDBO. Further prospective studies are required to confirm these findings.
Bilateral intraductal plastic stent (IS) placement is preferred for unresectable malignant hilar biliary obstruction (MHBO) owing to its stent patency and removability. However, certain clinical and technical conditions permit only unilateral drainage even for unresectable MHBO. A useful stent selection in such cases remains unclear. Among 360 retrospective patients with MHBO, 118 underwent unilateral drainage with an across-papillary plastic stent (PS), IS, or a self-expandable metallic stent (SEMS). Outcomes were compared based on clinical success, adverse events (AEs), recurrent biliary obstruction (RBO), time to RBO (TRBO), and reintervention, using propensity score matching (PSM) analysis. PSM identified 23 patients in each group for comparison. The RBO occurrence rates and median TRBO were 83
BACKGROUND:Intraductal papillary mucinous neoplasm (IPMN) is a well-recognized precursor of pancreatic cancer; however, the optimal surveillance strategy for IPMN remains controversial. This study aimed to evaluate the clinical impact of semiannual surveillance using endoscopic ultrasonography (EUS) and magnetic resonance imaging (MRI) for the detection of malignant transformation, including IPMN-derived and concomitant carcinoma. METHODS:This multicenter prospective observational study included 360 patients with branch-duct or mixed-type IPMN enrolled between April 2018 and December 2025. Patients underwent surveillance every 6 months with blood tests and EUS or MRI. The primary endpoint was the curative resection rate among patients diagnosed with IPMN-derived or concomitant carcinoma. Secondary endpoints included the incidence of newly developed worrisome features (WF) and high-risk stigmata (HRS), as well as the cumulative incidence of malignancy. RESULTS:During a median follow-up period of 69 months, newly developed WF and HRS were observed in 30.3% and 2.5% of patients, respectively. Malignant transformation was confirmed in 12 patients (3.3%), including nine with IPMN-concomitant carcinoma and three with IPMN-derived carcinoma. Curative resection was performed in 9 of these patients, resulting in a surgical transition rate of 75.0%. All malignant pancreatic lesions were detected at a resectable or borderline-resectable stage at diagnosis. CONCLUSIONS:Semiannual surveillance using EUS and MRI facilitated the detection of malignant pancreatic lesions at a surgically treatable stage in patients with IPMN. This surveillance strategy may be clinically valuable for identifying IPMN-derived and concomitant carcinoma at stages amenable to surgical treatment in high-risk populations.
Self-expandable metallic stents (SEMSs) are recommended for preoperative biliary drainage in patients with pancreatic cancer. However, they are associated with a relatively high incidence of non-recurrent biliary obstruction (RBO) adverse events (AEs), such as pancreatitis and cholecystitis. The 11.5-Fr large-bore plastic stent (LBPS) is a newly developed stent with a larger diameter than conventional plastic stents. The aim of the present study was to compare the clinical outcomes of LBPS and SEMS in preoperative biliary drainage for pancreatic cancer. We retrospectively evaluated 80 patients who underwent preoperative biliary drainage for pancreatic cancer between January 2011 and December 2025. Patients were divided into the LBPS and SEMS groups according to the stent placed. RBO occurred in 20.0