Clinical Trial Comparing ERCP vs ERCP and Transmural Gall Bladder Drainage

Cholelithiasis occurs in 10-20% of the general population. Up to 18% of these subjects will present symptoms. In patients with symptomatic choledocholithiasis who are not candidates for surgery with indication for ERCP, transmural drainage of the gallbladder reduces the risk of recurrence. The investigators propose a multicentric double-blind randomized trial. Our primary objective is to assess whether ERCP associated with transmural gallbladder drainage is able to reduce biliary disease income compared with ERCP in patients not candidates for surgery with symptomatic choledocholithiasis and cholelithiasis during one year of follow-up. Also the investigators will analyze the proportion of technical success and complications. The study population includes all patients older than 75 years with symptomatic choledocholithiasis. An estimated 75 subjects per group (ERCP alone and ERCP and transmural drainage) are needed.

NCT Number	NCT03921502
Lead Sponsor	Hospital del Rio Hortega Collaborators: Hospital Universitario Ramon y Cajal, Hospital General Universitario de Alicante
Conditions	Bile Duct; Obstruction, With Calculus, Choledocholithiasis
Enrollment	150 participants
Start Date	2019-08-01
Primary Completion	2022-12-01 (estimated)
Study Completion	2026-05-01 (estimated)
Updated on ClinicalTrials.gov	2025-03-11