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

Helsinki University Central Hospital (HUCH)

Status: Enrolling

Conditions: Cholangitis; Pancreatitis, Acute; Bleeding

Treatments: Device: endoscopic short duration papillary large balloon dilation

Study type: Interventional

Funder types: Other

Identifiers

NCT05061680

Largeballoon dilation

Details and patient eligibility

About

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.

Full 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

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

600 participants in 3 patient groups

short sphincterotomy +Short duration papillary large balloon dilation

Active Comparator group

Description:

Patients with short sphincterotomy

Treatment:

Device: endoscopic short duration papillary large balloon dilation

full sphincterotomy + short duration papillary balloon dilation

Active Comparator group

Description:

Patients with full lenght sphincterotomy

Treatment:

Device: endoscopic short duration papillary large balloon dilation

previous sphincterotomy + short duration papillary balloon dilation

Active Comparator group

Description:

Patients with previous sphincterotomy

Treatment:

Device: endoscopic short duration papillary large balloon dilation