Treatment of bile duct diseases using a mini-endoscopic system
Diagnosis and Percutaneous Treatment of Biliary Tract Diseases
This study is testing a new mini-endoscopic system to see if it can help people with bile duct diseases who can’t have regular endoscopic treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, BO) |
| Trial ID | NCT06816615 on ClinicalTrials.gov |
What this trial studies
This study focuses on optimizing the treatment of bile duct diseases in patients who are not candidates for traditional endoscopic procedures. Participants will receive percutaneous cholangioscopic-assisted treatment using the Spyglass system at the University Hospital of Bologna. The study aims to determine if this technique can resolve biliary issues and perform biopsies more efficiently than conventional methods. It includes a 24-month enrollment phase followed by a 36-month follow-up to assess treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a radiological diagnosis of gallstones or bile duct stenosis who are not eligible for endoscopic treatment.
Not a fit: Patients with severe untreatable coagulopathies will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive and more effective treatment option for patients with bile duct diseases.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving outcomes for patients with biliary diseases.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Radiological diagnosis of indeterminate gallstones or stenosis of the bile ducts not eligible for endoscopic treatment and/or previous failed endoscopic treatment * Good liver function (hemoglobin, hematocrit, GOT, GPT, GGT within normal ranges) * Age over 18 * Obtaining informed consent Exclusion Criteria: * presence of severe untreatable coagulopathies
Where this trial is running
Bologna, BO
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bo, Italy (Recruiting)
Study contacts
- Principal investigator: Alberta Cappelli, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Alberta Cappelli, MD
- Email: alberta.cappelli@aosp.bo.it
- Phone: +39 051 6362598
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.