Clinical trial · Observational
Artificial Intelligence for Digital Cholangioscopy Neoplasia Diagnosis
Clinical Validation of an Artificial Intelligence Software for Digital Cholangioscopy Diagnosis: an Observational Trial
NCT05147389CI-TRIAL-00062242completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Digital single-operator cholangioscopy (DSOC) findings achieve high diagnostic accuracy for neoplastic bile duct lesions. To date, there is not a universally accepted DSOC classification. Endoscopists' Intra and interobserver agreements vary widely. Cholangiocarcinoma (CCA) assessment through artificial intelligence (AI) tools is almost exclusively for intrahepatic CCA (iCCA). Therefore, more AI tools are necessary for assessing extrahepatic neoplastic bile duct lesions. In Ecuador, the investigators have recently proposed an AI model to classify bile duct lesions during real-time DSOC, which accurately detected malignancy patterns. This research pursues a clinical validation of our AI model for distinguishing between neoplastic and non-neoplastic bile duct lesions, compared with high DSOC experienced endoscopists.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Common Bile Duct Neoplasms | — | UNRESOLVED | — |
| Non-Neoplastic Bile Duct Disorder | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AI model classification | Diagnostic Test | — | UNRESOLVED |
| DSOC endoscopist experts' classification | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Neoplastic bile duct lesions
- description
- This group is confirmed by DSOC videos from patients with DSOC-confirmed neoplastic bile duct lesions, coming from each participating group. Each DSOC video corresponds to a complete DSOC procedure in a single patient. The neoplastic bile duct criteria are in accordance with the two following tools: the Robles-Medranda et al and the Mendoza classification. A further follow will be necessary to confirm neoplastic bile duct lesion and the type: pCCA or dCCA, local extension of iCCA, hepatocarcinoma mixed CCA/hepatocarcinoma, gallbladder cancer, pancreas cancer, or any other neoplastic bile duct lesion. Based on follow-up, videos from patients with confirmed non-neoplastic bile duct lesions will be re-assessed and re-classified or finally excluded by an expert blinded to clinical records and who do not participate in videos classification.
- interventionNames
- Diagnostic Test: AI model classification
- Diagnostic Test: DSOC endoscopist experts' classification
- label
- Non-neoplastic bile duct lesions
- description
- This group is confirmed by DSOC videos from patients with DSOC-confirmed non-neoplastic bile duct lesions, coming from each participating group. Each DSOC video corresponds to a complete DSOC procedure in a single patient. The non-neoplastic bile duct criteria are in accordance with the two following tools: the Robles-Medranda et al and the Mendoza classification. A further follow will be necessary to confirm non-neoplastic bile duct lesion and the type, when available: acute or chronic cholangitis secondary to stones or parasite's location, autoimmune cholestatic liver diseases as autoimmune sclerosant cholangitis, and primary biliary cholangitis. Based on follow-up, videos from patients with confirmed neoplastic bile duct lesions will be re-assessed and re-classified or finally excluded by an expert blinded to clinical records and who do not participate in videos classification.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * Patients referred to our center with an indication of DSOC due to suspicion of CBD tumor or indeterminate CBD stenosis. * Patients who authorized for recording DSOC procedure for this study. Exclusion Criteria: * Any clinical condition which makes DSOC inviable. * Patients with more than one DSOC. * Low quality of recorded DSOC videos, even for AI model as for the expert endoscopists. * Lost on a one-year follow-up after DSOC. * Disagreement between DSOC findings vs. one-year follow-up, even after re-assessment of respective DSOC videos.
References
Publications (7)
- BACKGROUNDKahaleh M, Gaidhane M, Shahid HM, Tyberg A, Sarkar A, Ardengh JC, Kedia P, Andalib I, Gress F, Sethi A, Gan SI, Suresh S, Makar M, Bareket R, Slivka A, Widmer JL, Jamidar PA, Alkhiari R, Oleas R, Kim D, Robles-Medranda CA, Raijman I. Digital single-operator cholangioscopy interobserver study using a new classification: the Mendoza Classification (with video). Gastrointest Endosc. 2022 Feb;95(2):319-326. doi: 10.1016/j.gie.2021.08.015. Epub 2021 Aug 31. PMID 34478737
- BACKGROUNDSethi A, Tyberg A, Slivka A, Adler DG, Desai AP, Sejpal DV, Pleskow DK, Bertani H, Gan SI, Shah R, Arnelo U, Tarnasky PR, Banerjee S, Itoi T, Moon JH, Kim DC, Gaidhane M, Raijman I, Peterson BT, Gress FG, Kahaleh M. Digital Single-operator Cholangioscopy (DSOC) Improves Interobserver Agreement (IOA) and Accuracy for Evaluation of Indeterminate Biliary Strictures: The Monaco Classification. J Clin Gastroenterol. 2022 Feb 1;56(2):e94-e97. doi: 10.1097/MCG.0000000000001321. PMID 32040050
- BACKGROUNDKahaleh M, Raijman I, Gaidhane M, Tyberg A, Sethi A, Slivka A, Adler DG, Sejpal D, Shahid H, Sarkar A, Martins F, Boumitri C, Burton S, Bertani H, Tarnasky P, Gress F, Gan I, Ardengh JC, Kedia P, Arnelo U, Jamidar P, Shah RJ, Robles-Medranda C. Digital Cholangioscopic Interpretation: When North Meets the South. Dig Dis Sci. 2022 Apr;67(4):1345-1351. doi: 10.1007/s10620-021-06961-z. Epub 2021 Mar 30. PMID 33783691
- RESULTSaraiva MM, Ribeiro T, Ferreira JPS, Boas FV, Afonso J, Santos AL, Parente MPL, Jorge RN, Pereira P, Macedo G. Artificial intelligence for automatic diagnosis of biliary stricture malignancy status in single-operator cholangioscopy: a pilot study. Gastrointest Endosc. 2022 Feb;95(2):339-348. doi: 10.1016/j.gie.2021.08.027. Epub 2021 Sep 8. PMID 34508767
- RESULTRobles-Medranda C, Oleas R, Sanchez-Carriel M, Olmos JI, Alcivar-Vasquez J, Puga-Tejada M, Baquerizo-Burgos J, Icaza I, Pitanga-Lukashok H. Vascularity can distinguish neoplastic from non-neoplastic bile duct lesions during digital single-operator cholangioscopy. Gastrointest Endosc. 2021 Apr;93(4):935-941. doi: 10.1016/j.gie.2020.07.025. Epub 2020 Jul 22.