Clinical Trial: A multicenter retrospective study on the prevention of impaired bile outflow by endoscopic biliary drainage following complete removal of common bile duct stones (Japan)

Tokyo, Sept. 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062881) titled 'A multicenter retrospective study on the prevention of impaired bile outflow by endoscopic biliary drainage following complete removal of common bile duct stones' on Sept. 12.

Study Type: Observational

Primary Sponsor: Institute - Oita Sanai Medical Center

Condition: Condition - common bile duct stone, acute cholangitis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to evaluate patients who underwent endoscopic stone extraction via ERCP for common bile duct stones, focusing on two major objectives:

1. Preventive effect of endoscopic biliary drainage (EBD) immediately after complete stone removal We will compare patients who received EBD immediately after complete stone removal with those who did not receive EBD, assessing:Patient-related factors,Procedure-related factors,Post-procedural factors.Through these analyses, we aim to clarify the preventive effect of EBD on postoperative biliary outflow obstruction and to compare the medical costs associated with each treatment strategy.

2. Risk factors for post-ERCP cholangitis in patients without EBD Among patients who did not undergo EBD, we will compare those who developed post-ERCP cholangitis with those who did not to identify risk factors associated with cholangitis after ERCP. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - Patients with asymptomatic or symptomatic common bile duct stones in whom complete stone removal by ERCP was confirmed on fluoroscopic imaging. Key exclusion criteria - Patients who underwent stone removal for severe acute cholangitis Patients with a history of gastrointestinal reconstruction other than Billroth one Patients with percutaneous biliary drainage or gallbladder drainage Patients with severe comorbidities involving other organs Patients deemed inappropriate for inclusion by the principal or sub investigator Target Size - 1800

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2026 Year 04 Month 01 Day Date of IRB - 2026 Year 06 Month 26 Day Anticipated trial start date - 2026 Year 06 Month 26 Day Last follow-up date - 2030 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071804

Disclaimer: Curated by HT Syndication.