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
1 other identifier
interventional
600
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2021
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 5, 2021
CompletedFirst Submitted
Initial submission to the registry
September 20, 2021
CompletedFirst Posted
Study publicly available on registry
September 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedMarch 1, 2023
February 1, 2023
4.7 years
September 20, 2021
February 28, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (3)
short sphincterotomy +Short duration papillary large balloon dilation
ACTIVE COMPARATORPatients with short sphincterotomy
full sphincterotomy + short duration papillary balloon dilation
ACTIVE COMPARATORPatients with full lenght sphincterotomy
previous sphincterotomy + short duration papillary balloon dilation
ACTIVE COMPARATORPatients with previous sphincterotomy
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age \>18 years
- Common bile duct stone \>10mm diameter
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Helsinki University Hospital
Helsinki, Finland
Turku University Hospital
Turku, Finland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mia Rainio, Md, PhD
Helsinki University Central Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 20, 2021
First Posted
September 29, 2021
Study Start
April 5, 2021
Primary Completion
December 31, 2025
Study Completion (Estimated)
December 31, 2026
Last Updated
March 1, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share