Short Duration Large Balloon Dilation to Remove Large Bile Duct Stones A Multicenter Study on Safety and Effectiveness with Short and Long-Term Follow-up

What this Trial Is About

Researchers are evaluating a procedure called endoscopic short duration papillary large balloon dilation for removing large bile duct stones in adults over 18 years old with stones larger than 10mm. This prospective multicenter study in Scandinavia aims to compare stone clearance rates and monitor both short- and long-term side effects such as pancreatitis, cholangitis, bleeding, perforations, and new or leftover biliary stones. Participants undergo either a short or full sphincterotomy followed by large balloon dilation guided by cholangiogram imaging. The dilation stops as soon as the narrowing waist of the papilla disappears, with the balloon size limited to the diameter of the bile duct. If initial stone extraction with sphincterotomy is unsuccessful, dilation serves as a rescue method. Patients are categorized based on the type of sphincterotomy received. During the study, adverse events are tracked through patient questionnaires and medical records at one month and one year after the procedure. The main outcomes measured within 30 days are rates of bleeding, pancreatitis, and cholangitis. The study is non-randomized and does not use masking. Participants will be monitored throughout the follow-up periods to assess safety and effectiveness of the dilation method.

Quick Large Balloon Dilatation for Removal of Large Bile Duct Stones (SHODBADI)