Artificial Intelligence-assisted Colonoscopy on Detection of Missed Proximal Lesions

Colon Polyp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04294355
• Other study ID #: UW 19-713
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: April 15, 2022

Study information

• Verified date: April 2022
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: April 15, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Colon Adenoma
• Colon Polyp

Intervention

Device:
• Artificial intelligence-Assisted colonoscopy
Artificial intelligence-Assisted colonoscopy for detection of colonic polyp

Procedure:
• Conventional colonoscopy
Conventional colonoscopy

Locations

Country	Name	City	State
China	Queen Mary Hospital	Hong Kong
Singapore	Tan Tock Seng Hospital	Singapore
Vietnam	Institute of Gastroenterology and Hepatology	Hanoi

Sponsors (3)

Lead Sponsor	Collaborator
The University of Hong Kong	Institute of Gastroenterology and Hepatology, Vietnam, Tan Tock Seng Hospital

Countries where clinical trial is conducted

China,  Singapore,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proximal adenoma missed rate	The proportion of patients with missed adenomas detected in the second examination only	One day
Secondary	Proximal polyp missed rate	The proportion of patients with missed adenomas detected in the second examination only	One day
Secondary	Proximal adenoma detection rate	The proportion of patients with at least one adenoma	One day
Secondary	Proximal polyp detection	The proportion of patients with at least one polyp	One day