Artificial Intelligence for Digital Cholangioscopy Neoplasia Diagnosis

Summary

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

• Common Bile Duct Neoplasms
• Non-Neoplastic Bile Duct Disorder

Interventions

DIAGNOSTIC_TEST

AI model classification

AIWorks is an artificial intelligence model for real-time cholangioscopic detection of neoplastic and non-neoplastic bile duct lesions. It allows you to choose using a video file or a USB camera input as the detection source. Once the input source has been selected, the software performs real-time detection by surrounding the area of interest (i.e., the area with malignancy features) inside a bounding box. All detections made are displayed on the right side of the screen and can also be reviewed afterwards.

DIAGNOSTIC_TEST

DSOC endoscopist experts' classification

Six endoscopists with high DSOC expertise will observe and classify a set of videos among neoplastic or non-neoplastic bile duct lesions following a Bernoulli distribution; blinded to clinical records and should have never attended said patients. Gastroenterologists from each center, with non-DSOC responsibility, will select DSOC videos and corresponding baseline data. DSOC videos and data will be gathered in one set. Each video represents a full DSOC for a single patient. The patient will be the unit of this study. The neoplastic bile duct criteria are in accordance with the Robles-Medranda et al and the Mendoza classifications (ie. Irregular mucosa surface, Tortuous and dilated vascularity, Irregular nodulations, Polyps, Ulceration, Honeycomb pattern, etc.). The experts will assess neoplastic bile duct by presence or absence of disaggregated criteria. Likewise, by Boolean logical operators, the statistical software will compute disaggregated answers.

Sponsors & Collaborators

• The Methodist Hospital Research Institute

  collaborator OTHER

• University of Sao Paulo

  collaborator OTHER

• Vrije Universiteit Brussel

  collaborator OTHER

• Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University

  collaborator OTHER

• Baylor St. Luke's Medical Center

  collaborator OTHER

• Universitair Ziekenhuis Brussel

  collaborator OTHER

• Instituto Ecuatoriano de Enfermedades Digestivas

  lead OTHER

Principal Investigators

• Carlos Robles-Medranda · Ecuadorian Institute of Digestive Diseases

Eligibility

Min Age

18 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-01

Primary Completion

2021-11-30

Completion

2022-05-01

Countries

• United States
• Belgium
• Brazil
• Ecuador

Study Locations