Artificial Intelligence-assisted Colonoscopy on Detection of Missed Proximal Lesions

Not Applicable

Completed

• Conditions: Colon Adenoma; Colon Polyp
• Interventions: Device: Artificial intelligence-Assisted colonoscopy; Procedure: Conventional colonoscopy

• Registration Number: NCT04294355
• Lead Sponsor: The University of Hong Kong

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

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 Timeline

• Study First Submitted: 2020-03-02
• Study First Submitted QC: 2020-03-03
• Study First Posted: 2020-03-04
• Study Start: 2021-03-01
• Primary Completion: 2022-03-31
• Status Verified: 2022-04
• Study Completion: 2022-04-15
• Last Update Submitted: 2022-04-20
• Last Update Posted: 2022-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

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

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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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Artificial intelligence-Assisted colonoscopy	Artificial intelligence-Assisted colonoscopy	Tandem colonoscopy of proximal colon assisted with artificial intelligence followed by conventional colonoscopy
Conventional colonoscopy	Conventional colonoscopy	Tandem conventional colonoscopy of proximal colon followed by usual conventional colonoscopy
Artificial intelligence-Assisted colonoscopy	Conventional colonoscopy	Tandem colonoscopy of proximal colon assisted with artificial intelligence followed by conventional colonoscopy

Primary Outcome Measures

Name	Time	Method
Proximal adenoma missed rate	One day	The proportion of patients with missed adenomas detected in the second examination only

Secondary Outcome Measures

Name	Time	Method
Proximal polyp detection	One day	The proportion of patients with at least one polyp
Proximal adenoma detection rate	One day	The proportion of patients with at least one adenoma
Proximal polyp missed rate	One day	The proportion of patients with missed adenomas detected in the second examination only

Trial Locations

Locations (3)

Queen Mary Hospital; 🇨🇳 Hong Kong, China

Tan Tock Seng Hospital; 🇸🇬 Singapore, Singapore

Institute of Gastroenterology and Hepatology; 🇻🇳 Hanoi, Vietnam