Artificial Intelligence-assisted Colonoscopy on Detection of Missed Proximal Lesions

Study Overview
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Brief Summary
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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

Detailed Description
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Centers Queen Mary Hospital, Hong Kong, China (Co-ordinating Center) Tan Tock Seng Hospital, Singapore, Singapore 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.

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

Conditions
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Colon Adenoma, Colon Polyp

Intervention / Treatment
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* Device: Artificial intelligence-Assisted colonoscopy
* Procedure: Conventional colonoscopy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized design
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Artificial intelligence