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

NCT ID: NCT05061680

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-05
• Study Completion Date: 2026-12-31

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

Conditions

Pancreatitis, Acute; Bleeding; Cholangitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

short sphincterotomy +Short duration papillary large balloon dilation

Patients with short sphincterotomy

Group Type: ACTIVE_COMPARATOR

endoscopic short duration papillary large balloon dilation

Intervention Type: DEVICE

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.

full sphincterotomy + short duration papillary balloon dilation

Patients with full lenght sphincterotomy

Group Type: ACTIVE_COMPARATOR

endoscopic short duration papillary large balloon dilation

Intervention Type: DEVICE

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.

previous sphincterotomy + short duration papillary balloon dilation

Patients with previous sphincterotomy

Group Type: ACTIVE_COMPARATOR

endoscopic short duration papillary large balloon dilation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mia Rainio

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mia Rainio, Md, PhD

Role: STUDY_DIRECTOR

Helsinki University Central Hospital

Locations

Helsinki University Hospital

Helsinki, , Finland

Site Status: RECRUITING

Turku University Hospital

Turku, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Mia Rainio, MD, PhD

Role: CONTACT

mia.rainio@hus.fi

+358505833060

Leena Kylänpää, MD, PhD

Role: CONTACT

leena.kylanpaa@hus.fi

+35894711

Facility Contacts

Mia Rainio, MD, PhD

Role: primary

mia.rainio@hus.fi

+358505833060

Leena Kylänpää, Md PhD

Role: backup

leena.kylanpaa@hus.fi

+35894711

Juha Grönroos, Professor

Role: primary

juha.gronroos@tyks.fi

+358 2 3130000

Other Identifiers

Largeballoon dilation

Identifier Type: -

Identifier Source: org_study_id