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

Overview

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

• Device ENDO-AID CADe
  ENDO-AID CADe will be used during the withdrawal process of the colonscopy

Primary outcome measures

• Post-colonoscopy adenomas at year 3 [Time frame: During the colonoscopy]

Secondary outcome measures (7)

• Post-colonoscopy AA [Time frame: During the colonoscopy]
• Post-colonoscopy advanced neoplasms [Time frame: During the colonoscopy]
• Post-colonoscopy SSL [Time frame: During the colonoscopy]
• Post-colonoscopy CRC [Time frame: During the colonoscopy]
• 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]
• High-risk and low-risk group according to USMSTF guideline [Time frame: During the colonoscopy]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Hong Kong · 1 center

• Prince of Wales Hospital — Hong Kong

Identifiers

NCT: NCT06251700 · 2023.541

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗