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Clinical Trial Summary

ESGE guidelines suggests 30-60 seconds endoscopic large balloon papillary dilation from the disappearance of the waist of the papilla. We have good results in stone removal with much quicker dilatations. Our technique is to follow the cholangiogram and stop the dilatation as soon as we notice the disappearance of the waist of the papilla. We are recruiting a multicenter Scandinavian prospective study of this dilatation technique. In this study, we are 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.

Clinical Trial Description

This study is planned as a multicenter Scandinavian prospective study including all the patients >18 years with >10mm diameter common bile duct stones visible in cholangiogram. Before ERCP all patient will be informed about this trial, and if they agree to participate this study, they need to give a written informed consent. The endoscopists will decide whether the first step will be large EST and stone extraction or small EST and dilatation. If simple EST does not success, the dilatation will remain as a rescue method. The diameter of dilatation balloon cannot exceed the diameter of common bile duct above the papilla. Cholangiogram is followed when papilla is dilated and the dilatation will be ended when the waist of the papilla disappears. The duration of the dilatation measured, but it does not define the ending of dilatation. All adverse events will be recorded one month and a year after the procedure. Classification of the patients: 1. EST and stone extraction 2. EPLBD when EST and stone extraction did not succeed 3. Short EST and EPLBD We collect the information of adverse events such as bleeding, pancreatitis, cholangitis with patient questionnaire as well as from the patient records one month and a year after the procedure ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05061680
Study type Interventional
Source Helsinki University Central Hospital
Contact Mia Rainio, MD, PhD
Phone +358505833060
Email [email protected]
Status Recruiting
Phase N/A
Start date April 5, 2021
Completion date December 31, 2026

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