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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: EST and stone extraction EPLBD when EST and stone extraction did not succeed Short EST and EPLBD The investigators will 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

Official Title
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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

Conditions
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Pancreatitis, Acute, Bleeding, Cholangitis

Intervention / Treatment
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* Device: endoscopic short duration papillary large balloon dilation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: short sphincterotomy +Short duration papillary large balloon dilation<br>Patients with short sphincterotomy | Device: endoscopic short duration papillary large balloon dilation<br>* 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.<br>|
| Active Comparator: full sphincterotomy + short duration papillary balloon dilation<br>Patients with full lenght sphincterotomy | Device: endoscopic short duration papillary large balloon dilation<br>* 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.<br>|
| Active Comparator: previous sphincterotomy + short duration papillary balloon dilation<br>Patients with previous sphincterotomy | Device: endoscopic short duration papillary large balloon dilation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of bleeding | need for additional intervention or need for blood transfusion and hemoglobin drop more than 2 gm/dL | 30 days | 
| Rate of pancreatitis | Plasma amylase rises >3 times the upper limit and newly developed stomach ace more than 24h | 30 days | 
| Rate of cholangitis | Fever >38 | 30 days |