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Trial record 1 of 1 for:    NCT04294355
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Artificial Intelligence-assisted Colonoscopy on Detection of Missed Proximal Lesions

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ClinicalTrials.gov Identifier: NCT04294355
Recruitment Status : Completed
First Posted : March 4, 2020
Last Update Posted : April 21, 2022
Sponsor:
Collaborators:
Tan Tock Seng Hospital
Institute of Gastroenterology and Hepatology, Vietnam
Information provided by (Responsible Party):
The University of Hong Kong

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Colon Adenoma Colon Polyp Device: Artificial intelligence-Assisted colonoscopy Procedure: Conventional colonoscopy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective randomized design
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Artificial Intelligence-assisted Colonoscopy Versus Conventional Colonoscopy for Missed Lesions in the Proximal Colon: A Prospective Multi-center Randomized Study in Asia
Actual Study Start Date : March 1, 2021
Actual Primary Completion Date : March 31, 2022
Actual Study Completion Date : April 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Proximal adenoma missed rate [ Time Frame: One day ]
    The proportion of patients with missed adenomas detected in the second examination only


Secondary Outcome Measures :
  1. Proximal polyp missed rate [ Time Frame: One day ]
    The proportion of patients with missed adenomas detected in the second examination only

  2. Proximal adenoma detection rate [ Time Frame: One day ]
    The proportion of patients with at least one adenoma

  3. Proximal polyp detection [ Time Frame: One day ]
    The proportion of patients with at least one polyp


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04294355


Locations
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China
Queen Mary Hospital
Hong Kong, China
Singapore
Tan Tock Seng Hospital
Singapore, Singapore
Vietnam
Institute of Gastroenterology and Hepatology
Hanoi, Vietnam, 0
Sponsors and Collaborators
The University of Hong Kong
Tan Tock Seng Hospital
Institute of Gastroenterology and Hepatology, Vietnam
Investigators
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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
More Information
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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT04294355    
Other Study ID Numbers: UW 19-713
First Posted: March 4, 2020    Key Record Dates
Last Update Posted: April 21, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The University of Hong Kong:
Colonoscopy
Artificial intelligence
Additional relevant MeSH terms:
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Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms