RecruitingNot ApplicableNCT05061680

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

Endoscopic Papillary Short Duration Large Balloon Dilatation for Removal of Large Bile Duct Stones: a Prospective Multicenter Study of Short and Long-term Adverse Events

Sponsor

Helsinki University Central Hospital

Enrollment

600 participants

Start Date

Apr 5, 2021

Study Type

INTERVENTIONAL

Conditions

Bleeding Cholangitis Pancreatitis, Acute

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

Min Age: 18 YearsMax Age: 95 Years

Plain Language Summary

Simplified for easier understanding

This study (SHODBADI) compares two methods of removing large bile duct stones (stones ≥10mm) during ERCP — an endoscopic procedure used to access the bile duct. The two methods are quick large balloon dilation (QLBD) versus a standard combination of sphincterotomy and balloon dilation. Large stones can be difficult to remove and may cause complications if left untreated. You may be eligible if: - You are over 18 years old (and under 95) - You have a common bile duct stone that is larger than 10mm in diameter You may NOT be eligible if: - Your anatomy has been altered by surgery (e.g., Billroth II or Roux-en-Y reconstruction) - You have common bile duct cysts - You have acute pancreatitis - You have a stricture or tumor in the lower bile duct - You have a bleeding disorder or are on anticoagulation medication - You are pregnant - You cannot give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEendoscopic short duration papillary large balloon dilation

During the large balloon papillary dilation investigators follow the cholangiogram and stop the dilatation as soon as the disappearance of the waist of the papilla is noticed.