Quick balloon dilation for removing large bile duct stones
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
This study is testing if a quick balloon method can help adults get rid of large bile duct stones safely and effectively.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 95 Years |
| Sex | All |
| Sponsor | Helsinki University Central Hospital Academic / other |
| Locations | 2 sites (Helsinki and 1 other locations) |
| Trial ID | NCT05061680 on ClinicalTrials.gov |
What this trial studies
This multicenter Scandinavian study investigates the effectiveness of quick large balloon dilation for the removal of large bile duct stones greater than 10mm in diameter. Patients over 18 years old will undergo endoscopic procedures where the dilation will be performed until the waist of the papilla disappears, as observed through cholangiography. The study aims to assess stone clearance rates and monitor short and long-term adverse events such as pancreatitis, cholangitis, and bleeding. Data will be collected through patient questionnaires and medical records at one month and one year post-procedure.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with common bile duct stones larger than 10mm.
Not a fit: Patients with altered anatomy, acute pancreatitis, or coagulation disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the efficiency and safety of bile duct stone removal, reducing complications for patients.
How similar studies have performed: Previous studies have shown promising results with similar endoscopic techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Helsinki and 1 other locations
- Helsinki University Hospital — Helsinki, Finland (Recruiting)
- Turku University Hospital — Turku, Finland (Recruiting)
Study contacts
- Study coordinator: Mia Rainio, MD, PhD
- Email: mia.rainio@hus.fi
- Phone: +358505833060
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.