The Long-term Effect of Artificial Intelligence-assisted Colonoscopy on Risk of Metachronous Advanced Colonic Lesion

March 8, 2026 updated by: Dr. Lui Ka-Luen, The University of Hong Kong

The goal of this prospective study is to to evaluate the prevalence of metachronous advanced colonic lesions in subsequent surveillance colonoscopies in patients who had previously undergone AI-assisted colonoscopy to conventional colonoscopy examinations.

The main question it aims to answer is whether employing AI-assisted colonoscopy can decrease the likelihood of metachronous advanced colonic lesions during subsequent surveillance colonoscopies.

Researchers will compare patient who undergo conventional colonoscopy in previous colonoscopy to see if AI-assisted colonoscopy can decrease the likelihood of metachronous advanced colonic lesions during subsequent surveillance colonoscopies. Participants will undergo surveillance colonoscopy to assess the presence of metachronous advanced colonic lesion

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

404

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Thomas KL Clinical Assoicate Professor, MD
  • Phone Number: 852 + 97360997
  • Email: tkllui@hku.kh

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital
        • Contact:
          • Thomas KL Clinical Associate Professor, MD
          • Phone Number: 852+97360997
          • Email: tkllui@hku.hk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Eligible participants are those who were previously enrolled and completed our randomized controlled trial comparing AI-assisted and conventional colonoscopy

Exclusion Criteria:

  • In addition to the baseline exclusion criteria of the index trial, patients who were found to have inflammatory bowel disease, colorectal cancer and underwent bowel resection would be excluded. Similar to index trial, patients who have developed severe comorbid illnesses that make surveillance colonoscopy and polypectomy unsafe, or become unable to provide informed consent for trial participation would also be excluded

Index trial: Lui TK, Lam CP, To EW, Ko MK, Tsui VWM, Liu KS, et al. Endocuff With or Without Artificial Intelligence-Assisted Colonoscopy in Detection of Colorectal Adenoma: A Randomized Colonoscopy Trial. Am J Gastroenterol. 2024;119(7):1318-25

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Surveillance colonoscopy
Procedure: Suveillance colonoscopy
Surveillance colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the cumulative risk of metachronous advanced colonic lesions
Time Frame: Three years
the cumulative risk of metachronous advanced colonic lesions
Three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cumulative risk of non-advanced metachronous adenoma and serrated lesions
Time Frame: three years
cumulative risk of non-advanced metachronous adenoma and serrated lesions
three years
mean number of metachronous advanced colonic lesions
Time Frame: three years
mean number of metachronous advanced colonic lesions
three years
mean number of metachronous adenomas, advanced adenomas, serrated lesions, and advanced serrated lesions
Time Frame: three years
mean number of metachronous advanced colonic lesions, adenomas, advanced adenomas, serrated lesions, and advanced serrated lesions
three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

February 28, 2028

Study Registration Dates

First Submitted

March 8, 2026

First Submitted That Met QC Criteria

March 8, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 8, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI Colonoscopy followup

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It would require the approval of local authority

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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