Actively Recruiting
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
Led by Helsinki University Central Hospital · Updated on 2023-03-01
600
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a procedure called endoscopic short duration papillary large balloon dilation for removing large bile duct stones in adults over 18 years old with stones larger than 10mm. This prospective multicenter study in Scandinavia aims to compare stone clearance rates and monitor both short- and long-term side effects such as pancreatitis, cholangitis, bleeding, perforations, and new or leftover biliary stones. Participants undergo either a short or full sphincterotomy followed by large balloon dilation guided by cholangiogram imaging. The dilation stops as soon as the narrowing (waist) of the papilla disappears, with the balloon size limited to the diameter of the bile duct. If initial stone extraction with sphincterotomy is unsuccessful, dilation serves as a rescue method. Patients are categorized based on the type of sphincterotomy received. During the study, adverse events are tracked through patient questionnaires and medical records at one month and one year after the procedure. The main outcomes measured within 30 days are rates of bleeding, pancreatitis, and cholangitis. The study is non-randomized and does not use masking. Participants will be monitored throughout the follow-up periods to assess safety and effectiveness of the dilation method.
CONDITIONS
Brief 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for informed consent and eligibility confirmation
Duration - Single procedure visit
Participants undergo endoscopic short duration papillary large balloon dilation with or without sphincterotomy to remove large bile duct stones. The procedure involves balloon dilatation guided by cholangiogram until the waist of the papilla disappears.
1 procedure visit (in-person)
Duration - 1 year after the procedure
Participants are monitored for adverse events such as bleeding, pancreatitis, and cholangitis through questionnaires and patient records.
2 follow-up visits at 1 month and 1 year after the procedure
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
L
Leena Kylänpää, MD, PhD
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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