Recruiting NCT05779436
Real-Time Cholangioscopy Artificial Intelligence Evaluation of Biliary Strictures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Biliary Stricture. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The purpose of this study is to demonstrate the feasibility and validity of a previously developed peroral cholangioscopy (POC) convolutional neural network (CNN) to determine the etiology of biliary strictures when used in real-time.
Primary outcome measures
- POC-CNN Model AUC [Time frame: Patients will be considered negative for malignancy only with 12 months of negative follow-up or definitive negative surgical histology.]
Secondary outcome measures (1)
- Test characteristics of POC-CNN [Time frame: Patients will be considered negative for malignancy only with 12 months of negative follow-up or definitive negative surgical histology.]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- University of Massachusetts — Worcester
- Mayo Clinic Minnesota — Rochester
Publications
- Marya NB, Powers PD, Marcello M, Rau P, Nasser-Ghodsi N, Marshall C, Zivny J, AbiMansour JP, Chandrasekhara V. Classification of Biliary Strictures Using Real-Time Cholangioscopy Artificial Intelligence: The SMART-AI Trial. Clin Gastroenterol Hepatol. 2026 Apr 9:S1542-3565(26)00245-4. doi: 10.1016/j.cgh.2026.03.033. Online ahead of print. PMID 41966465
Identifiers
NCT: NCT05779436 · 23-000450