Actively Recruiting
Quick Large Balloon Dilatation for Removal of Large Bile Duct Stones (SHODBADI)
Led by Helsinki University Central Hospital · Updated on 2023-03-01
600
Participants Needed
2
Research Sites
299 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Quick Large Balloon Dilatation for Removal of Large Bile Duct Stones (SHODBADI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age >18 years
- Common bile duct stone >10mm diameter
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Helsinki University Hospital
Helsinki, Finland
Actively Recruiting
2
Turku University Hospital
Turku, Finland
Actively Recruiting
Research Team
M
Mia Rainio, MD, PhD
CONTACT
L
Leena Kylänpää, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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