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COMPLETED
NCT06922877
NA

Optical Diagnosis With vs. Without Three-Dimensional Imaging for Small and Diminutive Colorectal Polyps

Sponsor: Xijing Hospital of Digestive Diseases

View on ClinicalTrials.gov

Summary

This study investigated whether adding a three-dimensional (3D) imaging view during colonoscopy helps doctors classify small colon polyps more accurately than standard colonoscopy without 3D. Polyps are small growths in the colon that may develop into cancer over time. When doctors remove polyps, they often examine them closely during the procedure to judge how likely they are to be precancerous-a process called optical diagnosis. In this study, two approaches to optical diagnosis were compared: diagnosis using standard colonoscopy without 3D, and diagnosis using the same colonoscopy with additional 3D imaging. Both groups used the same classification systems (JNET and WASP) to identify polyp type; the only difference was whether 3D imaging was used. The main question was whether adding 3D improves the agreement between the doctor's diagnosis during colonoscopy and the final laboratory diagnosis of the removed polyp. The study also collected safety information. Participants were randomly assigned to one of the two groups, like flipping a coin. Regardless of group, all participants underwent an initial colonoscopy to detect polyps, a second colonoscopy to remove polyps and perform optical diagnosis, and a follow-up period of up to 30 days to monitor for side effects. The study included adults with at least one colon polyp smaller than 10 mm that did not require a more advanced type of removal called ESD.

Official title: Optical Diagnosis With vs. Without Three-Dimensional Imaging for Small and Diminutive Colorectal Polyps: A Prospective Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

458

Start Date

2025-05-01

Completion Date

2026-04-30

Last Updated

2026-09-10

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Optical diagnosis based on JNET classification with WASP features (no 3D assistance)

Real-time optical diagnosis of colorectal polyps \<10 mm before polypectomy, based on the JNET classification with additional WASP features for JNET Type 1 lesions, using standard high-definition colonoscopy without 3D assistance.

DIAGNOSTIC_TEST

Optical diagnosis based on JNET classification with WASP features plus 3D imaging assistance

Real-time optical diagnosis of colorectal polyps \<10 mm before polypectomy, based on the JNET classification with additional WASP features for JNET Type 1 lesions, using standard high-definition colonoscopy with 3D imaging assistance.

Locations (1)

Xijing Hospital of Digestive Disease

Xi'an, Shaanxi, China