Longterm Effectiveness of Artificial Intelligence-assisted Colonoscopy on Adenoma Recurrence
- Conditions
- Screening Colonscopy
- Interventions
- Device: ENDO-AID CADe
- Registration Number
- NCT06251700
- Lead Sponsor
- Chinese University of Hong Kong
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 775
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.
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention arm ENDO-AID CADe CADe system will be used during withdrawal phase of colonscopy
- Primary Outcome Measures
Name Time Method Post-colonoscopy adenomas at year 3 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 Outcome Measures
Name Time Method Post-colonoscopy AA During the colonoscopy Incidence of post-colonoscopy advanced adenomas
Post-colonoscopy advanced neoplasms During the colonoscopy Incidence of post-colonoscopy advanced neoplasms
Post-colonoscopy SSL During the colonoscopy Incidence of post-colonoscopy SSL
Post-colonoscopy CRC During the colonoscopy Incidence of post-colonoscopy CRC
Post-colonoscopy adenomas and advanced adenomas During the colonoscopy Number of post-colonoscopy adenomas and advanced adenomas
Size and location of post-colonoscopy adenomas and advanced adenomas During the colonoscopy Size and location of post-colonoscopy adenomas and advanced adenomas
High-risk and low-risk group according to USMSTF guideline During the colonoscopy Proportion of subjects re-classified as high-risk and low-risk groups according to USMSTF guideline
Trial Locations
- Locations (1)
Prince of Wales Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong