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

Not Applicable

Recruiting

• Conditions: Pancreatitis, Acute; Bleeding; Cholangitis
• Interventions: Device: endoscopic short duration papillary large balloon dilation

• Registration Number: NCT05061680
• Lead Sponsor: Helsinki University Central Hospital

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.

Detailed 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

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

Study Timeline

• Study Start: 2021-04-05
• Study First Submitted: 2021-09-20
• Study First Submitted QC: 2021-09-20
• Study First Posted: 2021-09-29
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
full sphincterotomy + short duration papillary balloon dilation	endoscopic short duration papillary large balloon dilation	Patients with full lenght sphincterotomy
short sphincterotomy +Short duration papillary large balloon dilation	endoscopic short duration papillary large balloon dilation	Patients with short sphincterotomy
previous sphincterotomy + short duration papillary balloon dilation	endoscopic short duration papillary large balloon dilation	Patients with previous sphincterotomy

Primary Outcome Measures

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

Trial Locations

Locations (2)

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Turku University Hospital; 🇫🇮 Turku, Finland