Clinical trial NCT06251700: Longterm Effectiveness of Artificial Intelligence-assisted Colonoscopy on Adenoma Recurrence
Official title: Longterm Effectiveness of Artificial Intelligence-assisted Colonoscopy on Adenoma Recurrence - a Prospective Longitudinal Follow-up of Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Screening Colonscopy
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 775
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post-colonoscopy adenomas at year 3
timeFrame: During the colonoscopy
Secondary outcomes:
measure: Post-colonoscopy AA
timeFrame: During the colonoscopy
measure: Post-colonoscopy advanced neoplasms
timeFrame: During the colonoscopy
measure: Post-colonoscopy SSL
timeFrame: During the colonoscopy
measure: Post-colonoscopy CRC
timeFrame: During the colonoscopy
measure: Post-colonoscopy adenomas and advanced adenomas
timeFrame: During the colonoscopy
measure: Size and location of post-colonoscopy adenomas and advanced adenomas
timeFrame: During the colonoscopy
measure: High-risk and low-risk group according to USMSTF guideline
timeFrame: During the colonoscopy
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
References: