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Sponsor: Instituto Ecuatoriano de Enfermedades Digestivas
Conditions: Common Bile Duct Neoplasms, Non-Neoplastic Bile Duct Disorder
Interventions: AI model classification, DSOC endoscopist experts' classification
Countries: United States, Belgium, Brazil, Ecuador
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.
Sex: ALL
Age: 18 Years to 79 Years
Study type: OBSERVATIONAL
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.
- New Brunswick, New Jersey, United States
- Houston, Texas, United States
- Houston, Texas, United States
- Brussels, Belgium
- São Paulo, Brazil
- Guayaquil, Guayas, Ecuador