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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bleeding; Cholangitis; Pancreatitis, Acute
• Intervention / Treatment: Device: endoscopic short duration papillary large balloon dilation

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 Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mia Rainio, MD, PhD; Phone Number: +358505833060; Email: mia.rainio@hus.fi
• Study Contact Backup: Name: Leena Kylänpää, MD, PhD; Phone Number: +35894711; Email: leena.kylanpaa@hus.fi

Study Locations

• Finland
  • Helsinki, Finland
    • Recruiting
    • Helsinki University Hospital
    • Contact: Mia Rainio, MD, PhD; Phone Number: +358505833060; Email: mia.rainio@hus.fi
    • Contact: Leena Kylänpää, Md PhD; Phone Number: +35894711; Email: leena.kylanpaa@hus.fi
  • Turku, Finland
    • Recruiting
    • Turku University Hospital
    • Contact: Juha Grönroos, Professor; Phone Number: +358 2 3130000; Email: juha.gronroos@tyks.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: short sphincterotomy +Short duration papillary large balloon dilation; Patients with short sphincterotomy	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.
Active Comparator: full sphincterotomy + short duration papillary balloon dilation; Patients with full lenght sphincterotomy	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.
Active Comparator: previous sphincterotomy + short duration papillary balloon dilation; Patients with previous sphincterotomy	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Study Director: Mia Rainio, Md, PhD, Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2021
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (Actual): September 29, 2021

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Pancreatic Diseases; Bile Duct Diseases; Pancreatitis; Cholangitis
• Other Study ID Numbers: Largeballoon dilation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes