Using AI to evaluate biliary strictures in real-time
Real-Time Cholangioscopy Artificial Intelligence Evaluation of Biliary Strictures
Mayo Clinic · NCT05779436
This study is testing whether an AI tool can help doctors better identify the causes of bile duct blockages during certain endoscopic procedures for patients who need them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic (other) |
| Locations | 2 sites (Worcester, Massachusetts and 1 other locations) |
| Trial ID | NCT05779436 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the feasibility and validity of a convolutional neural network (CNN) designed for peroral cholangioscopy (POC) to identify the causes of biliary strictures during endoscopic procedures. The study will involve patients who are expected to undergo POC during endoscopic retrograde cholangiopancreatography (ERCP). By utilizing real-time AI analysis, the researchers hope to improve diagnostic accuracy and patient outcomes related to biliary strictures.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled to undergo POC during ERCP.
Not a fit: Patients under 18 years old or those who do not require cholangioscopy during their procedure will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the accuracy of diagnosing biliary strictures, leading to better-targeted treatments for patients.
How similar studies have performed: While this specific approach is novel, similar studies utilizing AI in medical diagnostics have shown promising results in other areas.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years old * Anticipation that patient may undergo POC during an endoscopic retrograde cholangioscopy * Pregnant patients can be included in the study. Use of the POC-CNN does not convey any new risk to the patient nor fetus. * Non-English speaking subjects will be included in the study. Consent for the procedure itself is always done with the assistance of an interpreter via telephone or video. Use of the POC-CNN will be discussed with all patients via this interpreter during the procedure consent. Exclusion Criteria: * Age \<18 years old * No indication that cholangioscopy will be performed during endoscopic retrograde cholangiopancreatography (ERCP) * Prisoner
Where this trial is running
Worcester, Massachusetts and 1 other locations
- University of Massachusetts — Worcester, Massachusetts, United States (RECRUITING)
- Mayo Clinic Minnesota — Rochester, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Vinay Chandrasekhara, MD — Mayo Clinic
- Study coordinator: Liz Lemke
- Email: lemke.elizabeth@mayo.edu
- Phone: 507-284-2511
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.
Conditions: Biliary Stricture