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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing cholangioscopy for evaluation biliary stricture |
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| Measure | Description | Time Frame |
|---|---|---|
| POC-CNN Model AUC | Area Under the Curve (AUC) analysis for POC-CNN for classification of malignant biliary stricture | Patients will be considered negative for malignancy only with 12 months of negative follow-up or definitive negative surgical histology. |
| Measure | Description | Time Frame |
|---|---|---|
| Test characteristics of POC-CNN | Sensitivity and Specificity of POC-CNN for the diagnosis of malignant biliary stricture, Sensitivity and Specificity of biliary brushings and biliary biopsies | Patients will be considered negative for malignancy only with 12 months of negative follow-up or definitive negative surgical histology. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with biliary strictures who are undergoing peroral cholangioscopy (POC) during endoscopic retrograde cholangiopancreatography (ERCP) for the evaluation of a biliary strictures will be identified via review of procedure listings at Mayo Clinic Rochester, Minnesota.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liz Lemke | Contact | 507-284-2511 | lemke.elizabeth@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Vinay Chandrasekhara, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts | Recruiting | Worcester | Massachusetts | 01655 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41966465 | Derived | 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. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Mayo Clinic Minnesota | Recruiting | Rochester | Minnesota | 55905 | United States |
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