A Prospective Study to Evaluate the Diagnostic Accuracy of Computer-aided Diagnosis (CADx) System in Real-time Characterization of Colorectal Neoplasia

NCT ID: NCT05414383

Last Updated: 2024-02-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 510 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2025-12-31

Brief Summary

The investigators hypothesize that a newly developed CADx system will have a higher diagnostic accuracy in predicting histopathology of colorectal neoplasia than both expert and junior endoscopists.

Detailed Description

Accurate diagnosis and characterization of colorectal polyps is essential before endoscopic resection. Optical diagnosis by enhanced imaging modality (e.g. Narrow Band Imaging, NBI) allows real-time prediction of histopathology. It can assist endoscopists to select the appropriate technique and differentiate between neoplastic or non-neoplastic polyps. Nevertheless, due to the substantial inter-observer variability, the widespread use was limited.

Recently, artificial intelligence and computer-aided polyp diagnosis (CADx) systems have evolved rapidly. The major limitation was the heterogeneity from different types of imaging modalities. Endocytoscopic images require extra steps for pre-staining and magnification, which are time consuming and operator dependent. As a result, it limits the generalisability and applicability in real-world settings.

A novel CADx system will be developed for real-time histopathological prediction of colorectal neoplasia, by using non-magnified conventional white-light and image enhanced endoscopy (NBI). The diagnostic accuracy of this CADx system will be compared with both expert and junior endoscopists.

Conditions

Colorectal Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CADx

Histopathology prediction by CADx device

CADx

Intervention Type: DEVICE

A novel CADx system for real-time histopathological prediction of colorectal neoplasia, by using non-magnified conventional white-light and image enhanced endoscopy.

Endoscopist

Real-time histopathology prediction by expert and non-expert endoscopists

No interventions assigned to this group

Interventions

CADx

A novel CADx system for real-time histopathological prediction of colorectal neoplasia, by using non-magnified conventional white-light and image enhanced endoscopy.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. They have received colonoscopy for screening, surveillance or symptom investigation;

2. They have endoscopic images and videos captured and stored during colonoscopy which are available to be retrieved;

3. They have histologically proven colorectal neoplasia.

4. Written consent obtained

Exclusion Criteria

1. Poor quality endoscopic images and videos defined as:

1. Incomplete visualization of the colorectal neoplasia due to technical reasons (e.g. out-of-focus, motion-blurred or insufficient illumination);

2. Artifacts due to mucus, air bubbles, stool, or blood.

2. Active gastrointestinal bleeding;

3. Fulminant colitis;

4. Obscured view due to poor bowel preparation;

5. Artificial staining of lesion due to chromoendoscopy.

6. Unable to obtain informed consent

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

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Louis Ho Shing Lau

Assitant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Felix Sia

Role: CONTACT

felixsia@cuhk.edu.hk

26370428

Thomas Lam

Role: CONTACT

thomaslam@cuhk.edu.hk

26370428

Other Identifiers

2022.160

Identifier Type: -

Identifier Source: org_study_id