NCT04294355

Artificial Intelligence-assisted Colonoscopy on Detection of Missed Proximal Lesions

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

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

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.

Conditions

• Colon Adenoma
• Colon Polyp

Interventions

Type	Name	Description
DEVICE	Artificial intelligence-Assisted colonoscopy	Artificial intelligence-Assisted colonoscopy for detection of colonic polyp
PROCEDURE	Conventional colonoscopy	Conventional colonoscopy

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-03-31
• Completion: 2022-04-15
• First posted: 2020-03-04
• Last updated: 2022-04-21

Locations

3 sites across 3 countries: China, Singapore, Vietnam