Prince of Wales Hospital
Hong Kong
Location status: Recruiting
Location contact
Louis Lau
CONTACT
NCT Number: NCT06251700
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Hong Kong
Location status: Recruiting
Louis Lau
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
ENDO-AID CADe will be used during the withdrawal process of the colonscopy
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.
Time frame: During the colonoscopy
Incidence of post-colonoscopy advanced adenomas
Time frame: During the colonoscopy
Incidence of post-colonoscopy advanced neoplasms
Time frame: During the colonoscopy
Incidence of post-colonoscopy SSL
Time frame: During the colonoscopy
Incidence of post-colonoscopy CRC
Time frame: During the colonoscopy
Number of post-colonoscopy adenomas and advanced adenomas
Time frame: During the colonoscopy
Size and location of post-colonoscopy adenomas and advanced adenomas
Time frame: During the colonoscopy
Proportion of subjects re-classified as high-risk and low-risk groups according to USMSTF guideline
Contact information is provided by the study sponsor or research team.
Chinese University of Hong Kong
Other
Longterm Effectiveness of Artificial Intelligence-assisted Colonoscopy on Adenoma Recurrence - a Prospective Longitudinal Follow-up of Randomized Controlled Trial
Acronym: ENDOAID-PRO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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