Tokyo, Nov. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059659) titled 'A multicenter prospective study on the efficacy of endoscopic ultrasound-guided antegrade stenting combined with hepaticogastrostomy (EUS-AS+HGS) for unresectable malignant biliary obstruction' on Nov. 6.

Study Type: Observational

Primary Sponsor: Institute - Wakayama Medical University

Condition: Condition - Patients with unresectable malignant biliary obstruction for whom transpapillary treatment is difficult, necessitating EUS-BD, in whom EUS-AS+HGS is attempted. Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - This study aims to evaluate the efficacy of EUS-guided antegrade stenting combined with hepaticogastrostomy (EUS-AS+HGS) as a biliary drainage method in patients with unresectable malignant biliary obstruction in whom transpapillary treatment is not feasible. A multicenter prospective design will be employed, and outcomes will be compared with historical data of EUS-HGS using metal stents. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients with unresectable advanced malignant tumors. 2. Patients with obstructive jaundice due to malignant tumors requiring biliary drainage. 3. Patients in whom ERCP-guided biliary drainage is not feasible or has failed. 4. Patients with obstructive jaundice due to malignant tumors who undergo EUS-AS+HGS as the biliary drainage procedure. 5. Patients in whom intrahepatic bile duct dilatation is confirmed by ultrasonography, CT, or other imaging modalities. 6. Patients aged 20 years or older at the time of consent. Key exclusion criteria - 1. Patients in whom endoscopic approach is not feasible. 2. Patients with a performance status of 4. 3. Patients with severe comorbidities involving other organs. 4. Patients who are unable to provide informed consent. 5. Any other patients deemed inappropriate for inclusion in the study by the principal or sub-investigator. Target Size - 49

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2022 Year 03 Month 01 Day Date of IRB - 2022 Year 10 Month 21 Day Anticipated trial start date - 2023 Year 01 Month 27 Day Last follow-up date - 2025 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067611

Disclaimer: Curated by HT Syndication.