Prospective, Randomized Controlled Study to Evaluate the Effect of Artificial Intelligence Assisted Optical Diagnosis of Advanced Adenomas

NCT ID: NCT05568992

Last Updated: 2022-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-06
• Study Completion Date: 2022-10-14

Brief Summary

This study is a clinical validation of our developed a computer-aided optical dignosis of advanced adenoma using non-magnified NBI image. This study is a randomized clinical trial comparing endoscopists' optical recognition of advanced adenoma for sending to histological examination with our computer-aided system. The hypothesis of the study is that the developed computer-aided system increases the percent of sending actual advanced adenoma Intelligence Assisted Optical Diagnosis of Advanced Adenomas

Detailed Description

Colorectal polyp diagnosis is based on endoscopic resection and histological analysis. An accurate optical diagnosis could avoid histological lesion of smaller lesions, reducing the costs associated with histological diagnosis. However, it should be noted this policy could only be applied in diminutive polys considering high proposition of advanced adenomas in polyps more than 5 mm. In addition, optical diagnosis criteria of advanced adenomas have not been validated for finding advanced adenomas among adenoma polyps. If as many as advanced adenomas as possible could be differentiated from non-advanced adenomas and be further sent for histological examination, this policy could be generalized to small polyps.

Considering this situation, the investigators tried to develop computer-aided optical dignosis of advanced adenoma using non-magnified NBI image with preliminary, satisfied results. In this study, the investigators next validate the investigators' developed computer-aided system for detecting advanced adenomas by comparing endoscopists' optical detection of advanced adenomas with or without the investigators' computer-aided system.

Conditions

Advanced Adenoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

AI assisted group

AI assisted endoscopist' optical detection of advanced adenomas among 100 images of polyps

Group Type: EXPERIMENTAL

AI system of optical detection of advanced adenomas

Intervention Type: DEVICE

AI system of optical detection of advanced adenomas

non-AI assisted group

Endoscopist' optical detection of advanced adenomas among 100 images of polyps using their experience of colonoscopy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

AI system of optical detection of advanced adenomas

AI system of optical detection of advanced adenomas

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Endoscopists with NBI experience

Exclusion Criteria

• Endoscopists without colonoscopy and NBI experience

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Xiaobo Li

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, , China

Countries

China

Other Identifiers

Renji KY[2019]009

Identifier Type: -

Identifier Source: org_study_id