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

Bleeding Clinical Trial

— SHODBADI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05061680
• Other study ID #: Largeballoon dilation
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2023
• Source: Helsinki University Central Hospital
• Contact: Mia Rainio, MD, PhD
• Phone: +358505833060
• Email: mia.rainio[@]hus.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Bleeding
• Cholangitis
• Pancreatitis
• Pancreatitis, Acute

Intervention

Device:
• endoscopic 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.

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

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