Video/image Library of Endoscopy Procedures for the Development of AI-empowered Endoscopy Quality Reporting and Educational Modules (Videotheque)

Creation of a Video/image Library of Annotated Full-length Endoscopy Procedures for the Development of Artificial Intelligence-empowered Endoscopy Quality Reporting and Educational Modules

The goal of this observational study is to establish a video/image library dataset of complete endoscopy or partial colonoscopy procedures for patients with rectal cancer or inflammatory bowel disease (IBD). With this video/image library, the aims are:

• to develop and validate novel AI-empowered solutions to automatically detect and report endoscopy quality metrics
• to develop automated endoscopy reporting solutions, auditing, and educational tools for residents and fellows to enhance their endoscopy skills.

The hypothesis is that a heterogeneous video/image library will provide:

• comprehensive and robust source material to develop AI models
• real-time quality feedback at the end of an endoscopy procedure.

Study Overview

• Status: Recruiting
• Conditions: Polyp of Colon; Artificial Intelligence (AI)

Detailed Description

The video/image library will be constructed by prospectively recruiting patients referred for endoscopy procedures for the upper or lower gastrointestinal tract diseases. Patients who have had a screening, surveillance, or diagnostic upper or lower endoscopy recorded as part of a research project at the CHUM will all be invited to participate in this banking.

A qualified and adequately trained study team representative will invite potential study patients to participate during and outpatient clinic visit, or at their arrival in the endoscopy unit on the day of the endoscopy.

Board-certified gastroenterologists, or trainees under supervison, will perform all upper or lower endoscopies at the CHUM. Patients will be prepared for endoscopies according to the most recent guidelines and current standards of care.

The complete or partial endoscopy will be video recorded and the data files will be saved without loss of image quality using Medicapture USB 300 (or equivalent) devices and stored locally in an on-site storage cloud. All videos will be recorded with timestamps burned into the recording. A research assistant will document all relevant informations and annotations during the procedure.

All esophagogastroduodenoscopies (EGDs) will be performed using the high-definition endoscopes. All findings (e.g., lesions, polyps, inflammations), diagnostics, and therapeutic procedures will be documented during EGDs.

The colonoscopies will be performed using high-definition colonoscopes equipped with image-enhanced techniques, or CAD systems, to provide real-time support to endoscopists to detect polyps of all sizes. If required, the endoscopists will be instructed to use white-light and narrow-band imaging to perform optical diagnosis (OD) for all 1-10mm polyps. An OD will first be performed without CADx, then CADx will be used to make a CAD-based OD.

After detecting a polyp and performing ODs, the endoscopists will remove all polyps using standard techniques. Endoscopists will annotate the withdrawal time before initiating a resection, and again when the resection is complete. All biopsy specimens and main polyp specimens will be sent to the institutional pathology laboratories (in separate jars) for histopathology assessments.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada
      • Recruiting
      • Centre Hospitalier de l'Université de Montréal
      • Contact: Samira Hanin; Phone Number: 30916 514-890-8000; Email: samira.hanin.chum@ssss.gouv.qc.ca
      • Contact: Daniel Von Renteln, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All eligible patients presenting at the CHUM for an upper or lower endoscopy will be approached for this study.

Description

Inclusion Criteria:

• ≥ 18 y.o.
• indication of undergoing a screening, surveillance, diagnostic, or therapeutic upper (EGD) or lower (colonoscopy) endoscopy

Exclusion Criteria:

• Coagulopathy defined as an elevated INR ≥ 2.5
• Platelet count ≤ 50,000/mm3
• Emergency endoscopy
• Poor general health defined as the American Society of Anesthesiologists physical status class >3

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EGD documented data	For EGD procedures, the following data will be documented: the exact time to reach the GE junction, the diaphragmatic hiatus, body/fondus/antrum of stomach, duodenum, procedural time during EGD, complications (immediate and late: first 24h post-procedure and 14 days post-procedure, respectively), the use of a distal attachment cap, insufflation and desufflation, cardiac retroflexion for facilitating visualization of mucosa during EGD, the use of existing AI platforms that increase lesion detection (CADe) and classification (CADx), the AI classification (autonomous CADx diagnosis), the endoscopists' ODs without CADx, the endoscopists' ODs after seeing the diagnosis from CADx (CADx-assisted diagnosis), the performance of endoscopists (measured with detection rates such as ADR, AADR, SSLDR, PDR, or with detection counts such as APC).	From enrollment to 14 days post-procedure
Colonoscopy documented data	For colonoscopy procedures, the following data will be documented: the exact time to reach the caecum, caecum intubation, the exact time of the visualisation of each anatomical landmarks, confirmed time of each lesion, ulcer, polyp visualised by the endoscopist, withdrawal time, mucosal inspection time, and complications (immediate and late: 24h post-procedure and 14 days post-procedure, respectively), the use of existing AI platforms that increase lesion detection (CADe) and classification (CADx), the AI classification (autonomous CADx diagnosis), the endoscopists' ODs without CADx, the endoscopists' ODs after seeing the diagnosis from CADx (CADx-assisted diagnosis), the performance of endoscopists (measured with detection rates such as ADR, AADR, SSLDR, PDR, or with detection counts such as APC). In the case of patients with rectal cancer, any active disease, such as tumor recurrence will be documented.	From enrollment to 14 days post-procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polyp, lesion, or ulcer-related characteristics	For upper and lower endoscopies, polyp, lesion, or ulcer-related characteristics will be documented: anatomical location, size estimated by the endoscopists, surface and vascular pattern and morphology. Any other pathological findings with the description of severity and anatomical location will be documented. Any biopsies taken during the procedure, and their location will be documented, including the number and a description of the biopsied tissue, as well as the reason for the biopsy.	From enrollment to the end of histology assessment
IBD data	In case of IBD indication, Crohn's disease and ulcerative colitis endoscopic characteristics will be graded and documented. The inflammation, ulceration/erosion, stricture, bleeding, and their related severity or extent in each colon segment will be documented. The endoscopic characteristics of the colon will also be documented, using components of the Mayo Score / DAI for Ulcerative Colitis, including vessels and bleeding.	From enrollment to the end of the procedure
Hiatal hernia data	In case of hiatal hernia, the size of the hernia along with the related type will be documented.	From enrollment to the end of the procedure
GERD data	In case of esophagitis (GERD), the Los Angeles classification of esophagitis will be used to define the grade and extent of the inflammation. The MUSE classification system will also be used to categorise esophageal lesions and strictures.	From enrollment to the end of the procedure
Barrett's esophagus data	In case of Barrett's esophagus, a detailed description of the esophagus will be documented: presence and extent of Barrett's esophagus, including the length of Barrett's segment in cm, the classification of Barrett's esophagus, the presence or absence of hiatal hernia and its size, and any sign of reflux esophagitis alongside their severity and location. The Prague classification will be used to describe the circumferential and maximal Barrett's segment length. The number and locations of biopsies taken within the Barrett's segment, at the GE junction, and in any suspicious area. The size and characteristics of any polyps or nodules found within the Barrett's segment will be documented as biopsies are essential for grading dysplasia and monitoring disease progression.	From enrollment to the end the histology assessment

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: February 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Colonic Polyps
• Other Study ID Numbers: 2023-10355/22.013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in research articles based on this video registry, after de-identification (text, tables, figures and appendices).
• IPD Sharing Access Criteria: Proposals should be directed to daniel.von.renteln.med@ssss.gouv.qc.ca . To gain access, data requestors will need to sign a data access agreement

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No