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

Recruiting now · Not applicable

Conditions studied: Pancreatitis, Acute, Bleeding, Cholangitis

In brief

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.

Key facts

Study ID

NCT05061680

Run by

Helsinki University Central Hospital

People needed

600

Starts

2021-04-05

Expected to finish

2026-12-31

Last updated by the study team

2023-03-01

Who can join

Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >18 years
• Common bile duct stone >10mm diameter

You may not qualify if…

• 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

Where it is running

• Helsinki University Hospital — Helsinki, Finland (enrolling)
• Turku University Hospital — Turku, Finland (enrolling)

Full record on ClinicalTrials.gov

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