Video/Image Library of Endoscopy Procedures for the Development of AI-empowered Endoscopy Quality Reporting and Educational Modules

NCT06822816 | Recruiting

• 1 other identifier: 2023-10355/22.013
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polyp of Colon; Artificial Intelligence (AI)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Polyp, lesion, or ulcer-related characteristics

  From enrollment to the end of histology assessment

• IBD data

  From enrollment to the end of the procedure

• Hiatal hernia data

  From enrollment to the end of the procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

RECRUITING

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterologist, Principal Scientist, MD, PhD

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 12, 2025
• Study Start: June 10, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• 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

Locations

CA (1)