Longterm Effectiveness of Artificial Intelligence-assisted Colonoscopy on Adenoma Recurrence - a Prospective Longitudinal Follow-up of Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 775
- Locations
- 1
- Primary Endpoint
- Post-colonoscopy adenomas at year 3
Study Overview
Brief Summary
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.
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Intervention arm
CADe system will be used during withdrawal phase of colonscopy
Intervention: ENDO-AID CADe (Device)
Outcomes
Primary Outcomes
Post-colonoscopy adenomas at year 3
Time Frame: During the colonoscopy
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.
Secondary Outcomes
- Post-colonoscopy AA(During the colonoscopy)
- Post-colonoscopy advanced neoplasms(During the colonoscopy)
- Post-colonoscopy SSL(During the colonoscopy)
- Post-colonoscopy CRC(During the colonoscopy)
- Post-colonoscopy adenomas and advanced adenomas(During the colonoscopy)
- Size and location of post-colonoscopy adenomas and advanced adenomas(During the colonoscopy)
- High-risk and low-risk group according to USMSTF guideline(During the colonoscopy)
Investigators
Louis Ho Shing Lau
Assistant Professor
Chinese University of Hong Kong