Longterm Effectiveness of Artificial Intelligence-assisted Colonoscopy on Adenoma Recurrence (ENDOAID-PRO)

Longterm Effectiveness of Artificial Intelligence-assisted Colonoscopy on Adenoma Recurrence - a Prospective Longitudinal Follow-up of Randomized Controlled Trial

We hypothesize that AI-assisted colonoscopy can reduce post-colonoscopy neoplasia incidence after 3 years, over standard colonoscopy. Moreover, this protective effect may allow surveillance intervals to be lengthened, by modifying long-term outcome of high-risk subgroup.

Study Overview

• Status: Recruiting
• Conditions: Screening Colonscopy
• Intervention / Treatment: Device: ENDO-AID CADe

Detailed Description

Between April 2021 and July 2022, our group completed a parallel-group, randomized controlled trial in Hong Kong. [ENDOAID-TRAIN study; NCT04838951] 856 subjects undergoing colonoscopies were randomized 1:1 to receive colonoscopies with CADe (ENDO-AID, Olympus Co., Japan) or standard colonoscopies (control). Our study proved that AI-assisted colonoscopies could increase the overall ADR, especially small-to-medium size adenomas. It remains questionable whether the increased detection and removal of these non-advanced adenomas can be translated into any sustained long-term benefit. The impact of this AI-driven intensive surveillance on general population and healthcare system is also largely unknown. In this research project, we aim to assess the long-term effectiveness of AI-assisted colonoscopy on adenoma recurrence and PCCRC prevention, by conducting a real-world, prospective study with longitudinal extension from a randomized trial.

• Study Type: Interventional
• Enrollment (Estimated): 775
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Felix Sia; Phone Number: 26370428; Email: felixsia@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Prince of Wales Hospital
    • Contact: Louis Lau

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

Subjects are eligible if:

(i) They underwent randomization to receive colonoscopy with/without CADe in ENDOAID-TRAIN study [NCT04838951]; (ii) They are fit and willing to undergo surveillance colonoscopy at year 3; (iii) Written informed consent obtained.

Exclusion Criteria:

Subjects will be excluded from the study if they have any of the followings:

(i) Incomplete colonoscopy during index procedure; (ii) Known residual colorectal neoplasia not removed (except hyperplastic polyps); (iii) Underwent unscheduled interval colonoscopy before year 3; (iv) Contraindications to surveillance colonoscopy at year 3; (v) Advanced comorbid (American Society of Anesthesiologists grade 4 or above); (vi) History of CRC, hereditary polyposis syndrome or inflammatory bowel disease; (vii) History of colectomy at any time point.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; CADe system will be used during withdrawal phase of colonscopy	Device: ENDO-AID CADe; ENDO-AID CADe will be used during the withdrawal process of the colonscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-colonoscopy adenomas at year 3	The primary endpoint is the incidence of post-colonoscopy adenomas at year 3, which is the composite of new occurrence and metachronous recurrence of adenomas during surveillance.	During the colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-colonoscopy AA	Incidence of post-colonoscopy advanced adenomas	During the colonoscopy
Post-colonoscopy advanced neoplasms	Incidence of post-colonoscopy advanced neoplasms	During the colonoscopy
Post-colonoscopy SSL	Incidence of post-colonoscopy SSL	During the colonoscopy
Post-colonoscopy CRC	Incidence of post-colonoscopy CRC	During the colonoscopy
Post-colonoscopy adenomas and advanced adenomas	Number of post-colonoscopy adenomas and advanced adenomas	During the colonoscopy
Size and location of post-colonoscopy adenomas and advanced adenomas	Size and location of post-colonoscopy adenomas and advanced adenomas	During the colonoscopy
High-risk and low-risk group according to USMSTF guideline	Proportion of subjects re-classified as high-risk and low-risk groups according to USMSTF guideline	During the colonoscopy

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Actual): February 9, 2024

Study Record Updates

• Last Update Posted (Actual): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 27, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease Attributes; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Recurrence; Adenoma
• Other Study ID Numbers: 2023.541

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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