Artificial Intelligence-assisted Colonoscopy on Detection of Missed Proximal Lesions

April 20, 2022 updated by: The University of Hong Kong

Artificial Intelligence-assisted Colonoscopy Versus Conventional Colonoscopy for Missed Lesions in the Proximal Colon: A Prospective Multi-center Randomized Study in Asia

This is a prospective multi-center randomized study is to determine whether the use of artificial intelligence (AI)-assistance could reduce the miss rates of polyps and adenomas in the proximal colon during tandem examination

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Centers

  1. Queen Mary Hospital, Hong Kong, China (Co-ordinating Center)
  2. Tan Tock Seng Hospital, Singapore, Singapore
  3. Institute of Gastroenterology and Hepatology, Vietnam Union of Science and Technology Association, Hanoi, Vietnam

Study population

Inclusion:

All adult patients, aged 40 or above, undergoing outpatient colonoscopy in the participating centers will be recruited.

Exclusion:

  • history of inflammatory bowel disease
  • history of colorectal cancer
  • previous bowel resection (apart from appendectomy)
  • Peutz-Jeghers syndrome, familial adenomatous polyposis or other polyposis syndromes
  • bleeding tendency or severe comorbid illnesses for which polypectomy is considered unsafe.

Post-randomization exclusion:

  • Cecum could not be intubated for various reasons
  • Boston Bowel Preparation Scale (BBPS) score of the proximal colon is <2

Study design This is a prospective randomized trial comparing the miss rates of proximal colonic lesions by AI assisted colonoscopy or conventional colonoscopy (Fig. 1). The study will be conducted in the Endoscopy Centre of the participating hospitals.

Randomization Eligible patients in each center will be randomly allocated in a 1:1 ratio to undergo tandem colonoscopy of the proximal colon first with AI-assistance and follow by conventional white light colonoscopy (Group 1) or conventional white light colonoscopy without AI assistance follow by conventional colonoscopy (Group 2). Proximal colon refers to colonic segment proximal to the splenic flexure. Randomization will be conducted in blocks of 4 by computer generated random sequences and stratified according to indications of colonoscopy (symptomatic vs screening/surveillance). Patients will be blinded to the group assignment.

Study Type

Interventional

Enrollment (Actual)

216

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 Locations

  • China
      • Hong Kong, China
        • Queen Mary Hospital
  • Singapore
      • Singapore, Singapore
        • Tan Tock Seng Hospital
  • Vietnam
      • Hanoi, Vietnam
        • Institute of Gastroenterology and Hepatology

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All adult patients, aged 40 or above, undergoing outpatient colonoscopy in the participating centers will be recruited

Exclusion Criteria:

  • history of inflammatory bowel disease
  • history of colorectal cancer
  • previous bowel resection (apart from appendectomy)
  • Peutz-Jeghers syndrome, familial adenomatous polyposis or other polyposis syndromes
  • bleeding tendency or severe comorbid illnesses for which polypectomy is considered unsafe.

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Artificial intelligence-Assisted colonoscopy
Tandem colonoscopy of proximal colon assisted with artificial intelligence followed by conventional colonoscopy
Device: Artificial intelligence-Assisted colonoscopy
Artificial intelligence-Assisted colonoscopy for detection of colonic polyp
Procedure: Conventional colonoscopy
Conventional colonoscopy
Active Comparator: Conventional colonoscopy
Tandem conventional colonoscopy of proximal colon followed by usual conventional colonoscopy
Procedure: Conventional colonoscopy
Conventional colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proximal adenoma missed rate
Time Frame: One day
The proportion of patients with missed adenomas detected in the second examination only
One day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proximal polyp missed rate
Time Frame: One day
The proportion of patients with missed adenomas detected in the second examination only
One day
Proximal adenoma detection rate
Time Frame: One day
The proportion of patients with at least one adenoma
One day
Proximal polyp detection
Time Frame: One day
The proportion of patients with at least one polyp
One day

Collaborators and Investigators

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

Sponsor

The University of Hong Kong

Collaborators

Tan Tock Seng Hospital
Institute of Gastroenterology and Hepatology, Vietnam

Investigators

  • Principal Investigator: Ka Luen, Thomas Lui, MBBS, Queen Mary Hospital, the University of Hong Kong
  • Study Director: Wai Keung Leung, MD, Queen Mary Hospital, 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)

March 1, 2021

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

April 15, 2022

Study Registration Dates

First Submitted

March 2, 2020

First Submitted That Met QC Criteria

March 3, 2020

First Posted (Actual)

March 4, 2020

Study Record Updates

Last Update Posted (Actual)

April 21, 2022

Last Update Submitted That Met QC Criteria

April 20, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 19-713

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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