Clinical trial NCT05061680: Quick Large Balloon Dilatation for Removal of Large Bile Duct Stones (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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatitis, Acute
Bleeding
Cholangitis
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2021-09-29
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Rate of bleeding
timeFrame: 30 days
measure: Rate of pancreatitis
timeFrame: 30 days
measure: Rate of cholangitis
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Mia Rainio, Md, PhD
role: STUDY_DIRECTOR
References: