Treatment of bile duct diseases using a mini-endoscopic system

Is this trial a fit for you?

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

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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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.