Artificial Intelligence for Digital Cholangioscopy Neoplasia Diagnosis

Completed

Conditions studied: Common Bile Duct Neoplasms, Non-Neoplastic Bile Duct Disorder

In brief

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.

Key facts

Study ID

NCT05147389

Run by

Instituto Ecuatoriano de Enfermedades Digestivas

People needed

170

Starts

2020-10-01

Expected to finish

2022-05-01

Last updated by the study team

2022-11-17

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University — New Brunswick, New Jersey, United States
• Baylor Saint Luke's Medical Center — Houston, Texas, United States
• Houston Methodist Hospital — Houston, Texas, United States
• Department of Advanced Interventional Endoscopy, Universitair Ziekenhuis Brussel (UZB)/Vrije Universiteit Brussel (VUB) — Brussels, Belgium
• Serviço de Endoscopía Gastrointestinal do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo — São Paulo, Brazil
• Carlos Robles-Medranda — Guayaquil, Guayas, Ecuador

Full record on ClinicalTrials.gov

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