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Trial Title:
Longterm Effectiveness of Artificial Intelligence-assisted Colonoscopy on Adenoma Recurrence
NCT ID:
NCT06251700
Condition:
Screening Colonscopy
Conditions: Official terms:
Adenoma
Recurrence
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
ENDO-AID CADe
Description:
ENDO-AID CADe will be used during the withdrawal process of the colonscopy
Arm group label:
Intervention arm
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Prince of Wales Hospital
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Recruiting
Contact:
Last name:
Louis Lau
Start date:
January 24, 2024
Completion date:
April 30, 2027
Lead sponsor:
Agency:
Chinese University of Hong Kong
Agency class:
Other
Source:
Chinese University of Hong Kong
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06251700
