NCT07932275 Long-term Complications in Patients With Previous Endoscopic Papillary Large Balloon Dilation: a Nationwide Retrospective Study
| NCT ID | NCT07932275 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia |
| Condition | Endoscopic Papillary Large Balloon Dilation |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-01-15 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2025-01-15 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Endoscopic retrograde cholangiopancreatography (ERCP) using standard techniques successfully removes common bile duct stones in most cases, but in 10-15% of patients, complex stone features or challenging biliary anatomy require advanced methods such as Endoscopic Papillary Large Balloon Dilation (EPLBD). Although EPLBD effectively facilitates the removal of difficult stones, it disrupts the papillary orifice and removes the natural barrier between the duodenum and the biliary tract, potentially increasing the risk of bacterial translocation and ascending cholangitis. This study aims to evaluate the long-term outcomes (over one year) in patients undergoing EPLBD, focusing primarily on the incidence of post-procedure cholangitis and secondarily on the rate of recurrent choledocholithiasis.
Eligibility Criteria
Inclusion Criteria: * All patients with a diagnosis of choledocholithiasis who underwent ERCP with EPLBD from January 2014 to March 2023 with complete bile duct stone clearance in one or multiple ERCP sessions will be included in the study. Exclusion Criteria: * Patients with age less than 18 years old or with surgically altered anatomy or with orthotopic liver transplantation will be excluded from the study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07932275 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Endoscopic Papillary Large Balloon Dilation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07932275 currently recruiting?
Yes, NCT07932275 is actively recruiting participants. Contact the research team at a.anderloni@smatteo.pv.it for enrollment information.
Where is the NCT07932275 trial being conducted?
This trial is being conducted at Pavia, Italy.
Who is sponsoring the NCT07932275 clinical trial?
NCT07932275 is sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. The trial plans to enroll 1,000 participants.