Clinical trial Recruiting at 2 sites Interventional Ages 18 to 95

Quick balloon dilation for removing large bile duct stones

Official title: 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

Run by Helsinki University Central Hospital · NCT05061680 · Data updated 2026-11-12

This study is testing if a quick balloon method can help adults get rid of large bile duct stones safely and effectively.

Quick facts

Study typeInterventional
Ages18 Years to 95 Years
SexAll
Enrollment600 (estimated)
SponsorHelsinki University Central Hospital
Academic / other
Locations2 sites (Helsinki and 1 other locations)
StatusRecruiting
StartedApril 5, 2021
Main results expectedDecember 31, 2025
Study endsDecember 31, 2026
Registry record updatedMarch 1, 2023
Trial IDNCT05061680 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults over 18 years with common bile duct stones larger than 10mm.

Probably not a fit

Patients with altered anatomy, acute pancreatitis, or coagulation disorders may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Previous studies have shown promising results with similar endoscopic techniques, suggesting potential for success in this approach.

Who can join: the full rules

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 it's running

  • Helsinki University Hospital
    Helsinki, Finland
    Recruiting
  • Turku University Hospital
    Turku, Finland
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.