170
Participants
Start Date
October 1, 2020
Primary Completion Date
November 30, 2021
Study Completion Date
May 1, 2022
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.
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."
Baylor Saint Luke's Medical Center, Houston
Houston Methodist Hospital, Houston
Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University, New Brunswick
Department of Advanced Interventional Endoscopy, Universitair Ziekenhuis Brussel (UZB)/Vrije Universiteit Brussel (VUB), Brussels
Serviço de Endoscopía Gastrointestinal do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo
Carlos Robles-Medranda, Guayaquil
The Methodist Hospital Research Institute
OTHER
University of Sao Paulo
OTHER
Vrije Universiteit Brussel
OTHER
Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
OTHER
Baylor St. Luke's Medical Center
OTHER
Universitair Ziekenhuis Brussel
OTHER
Instituto Ecuatoriano de Enfermedades Digestivas
OTHER