Screening Colonscopy
Conditions
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.
Interventions
DEVICEENDO-AID CADe
ENDO-AID CADe will be used during the withdrawal process of the colonscopy
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 AA | During the colonoscopy | Incidence of post-colonoscopy 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 |
| Post-colonoscopy adenomas and advanced adenomas | During the colonoscopy | Number of post-colonoscopy adenomas and advanced adenomas |
Countries
Hong Kong
Contacts
Primary ContactFelix Sia
Outcome results
None listed