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Recruiting NCT05061680

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

Trial Parameters

Condition Pancreatitis, Acute
Sponsor Helsinki University Central Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 600
Sex ALL
Min Age 18 Years
Max Age 95 Years
Start Date 2021-04-05
Completion 2025-12-31
Interventions
endoscopic short duration papillary large balloon dilation

Brief 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.

Eligibility Criteria

Inclusion Criteria: * Age \>18 years * Common bile duct stone \>10mm diameter Exclusion Criteria: * Altered anatomy after surgery (B II, Roux-en-Y reconstruction) * Common bile duct cysts * Acute pancreatitis * Distal common bile duct stricture or tumor * Coagulation disorders * Ongoing coagulation medication * Pregnancy * Inability to give an informed consent

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