Classification of Biliary Strictures Using Real-Time Cholangioscopy Artificial Intelligence: The SMART-AI Trial.
Neil B Marya, Patrick D Powers, Matthew Marcello...
https://pubmed.ncbi.nlm.nih.gov/41966465Actively Recruiting
Age: 18Years +
All Genders
ID05779436
Real-Time Cholangioscopy Artificial Intelligence Evaluation of Biliary Strictures
Led by Mayo Clinic · Updated on 2026-05-01
100
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of a previously developed artificial intelligence tool, a convolutional neural network (CNN), applied during peroral cholangioscopy (POC) to identify the causes of biliary strictures in real-time. The study focuses on assessing whether this AI tool is feasible and valid for clinical use in determining malignancy or benign causes of bile duct narrowing. Participants who may undergo POC during an endoscopic retrograde cholangioscopy (ERCP) will be observed. The AI model will analyze imaging during the procedure to help determine the nature of biliary strictures. The study includes all adult patients 18 years and older, including pregnant and non-English speaking individuals. There are no additional treatments or interventions; the study observes the AI tool's performance during standard clinical procedures. During the study, researchers will follow patients who undergo cholangioscopy and review their health outcomes for up to 12 months to confirm the accuracy of the AI model. The main measure is the model's ability to correctly identify malignancy versus non-malignancy, verified by follow-up or surgical results. Participants' care and clinical procedures will be monitored as usual, with no extra risk introduced by the AI evaluation. The study is expected to conclude by September 2027.
CONDITIONS
Brief Title
Real-Time Cholangioscopy Artificial Intelligence Evaluation of Biliary Strictures
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Patient is expected to undergo peroral cholangioscopy during an endoscopic retrograde cholangioscopy
- Pregnant patients are eligible; use of the AI tool does not add risk to patient or fetus
- Non-English speaking patients are eligible with interpreter assistance during consent
You will not qualify if you...
- Age under 18 years
- No plan for cholangioscopy during endoscopic retrograde cholangiopancreatography (ERCP)
- Current prisoner status
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Day of procedure
Participants undergo cholangioscopy as part of their evaluation for biliary strictures.
1 visit (in-person)
Long-term Monitoring
Duration - 12 months
Participants are followed for up to 12 months to confirm negative or positive malignancy status after initial evaluation.
Periodic follow-up visits up to 12 months
Trial Site Locations
Total: 2 locations
1
University of Massachusetts
Worcester, Massachusetts, United States, 01655
Actively Recruiting
2
Mayo Clinic Minnesota
Rochester, Minnesota, United States, 55905
Actively Recruiting
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Research Team
L
Liz Lemke
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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