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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | CADe system will be used during withdrawal phase of colonscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENDO-AID CADe | Device | ENDO-AID CADe will be used during the withdrawal process of the colonscopy |
|
| 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 |
| 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 |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Felix Sia | Contact | 26370428 | felixsia@cuhk.edu.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Recruiting | Hong Kong | Hong Kong |
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| 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 |