Clinical Trial

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

Study acronym: SHODBADI
Recruiting
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Record status
This record was last updated March 1, 2023 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
ESGE guidelines suggests 30-60 seconds endoscopic large balloon papillary dilation from the disappearance of the waist of the papilla. The investigators have good results in stone removal with much quicker dilatations when the cholangiogram is followed and the dilation is finished as soon as the disappearance of the waist of the papilla is seen. This Scandinavian multicenter prospective study is especially interested in stone clearance rate and short and long-term adverse events such as pancreatitis, cholangitis, bleeding, perforations, residual biliary stones, and newly developing biliary stones.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2021-09-20; most recent amendment 2023-02-28.
Trial Details
NCT Number NCT05061680
Lead Sponsor Helsinki University Central Hospital
Conditions Pancreatitis, Acute, Bleeding, Cholangitis
Enrollment 600 participants
Start Date 2021-04-05
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2023-03-01