The validation study of detectability and diagnostic accuracy of AI-aided endoscopic diagnosis system for colonoscopy

Phase 3

• Conditions: Colorectal polyps; Colorectal adenoma/cancer/polyp; D015179

• Registration Number: JPRN-jRCTs032190061
• Lead Sponsor: Tamai Naoto

Brief Summary

A total of 358 patients were enrolled and 179 patients were assigned to the SC-first group or CADe-first group. The AMR of the CADe-first group was significantly lower than that of the SC-first group (13.8%vs.36.7%,P<0.0001). Similar results were observed for the polyp miss rate (14.2%vs.40.6%,P<0.0001). The adenoma detection rate of CADe-assisted colonoscopy was 64.5%, which was significantly higher than that of standard colonoscopy (53.6%;P=0.036).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-24
• Study Completion: 2020-04-10
• Results First Posted: 2021-07-03
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 358

Inclusion Criteria

In patients scheduled for colonoscopy / treatment, patients who meet the following criteria.
1.40-80 years old
2.Patients who gave written informed consent based on their own intention after receiving sufficient explanation about this study
3.Informed consensus has been obtained that endoscopic resection should be performed if a lesion is found
4.The examination purpose is for screening of colon cancer or surveillance after endoscopic treatment of colorectal lesions

Exclusion Criteria

1.Patients with known inflammatory bowel disease and colonic stenosis
2.Patients with known familial adenomatous polyposis syndrome
3.Patients with known colorectal cancer/polyp
4.Patients who have had colon surgery in the past (except for appendectomy and surgery on the anus)
5.Patients with high risk of bleeding after endoscopic treatment, and difficult management of anticoagulation or antiplatelet agent.
6.Patients with severe organ failure (cirrhosis of Child C, heart failure of ACC / AHA stage D)
7.Pregnant patient
8.Patients who are judged as ineligible for registration by attending doctors

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adenoma miss rate

Secondary Outcome Measures

Name	Time	Method
Adenoma miss rate per patient, Adenoma detection rate, Polyp miss rate, Polyp miss rate per patient, Polyp detection rate, Mean number of adenomas per procedure