A Prospective Study to Evaluate the Performance of a Real-time System in the Estimation of Colorectal Polyp Size

NCT ID: NCT06957015

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 278 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2028-01-01

Brief Summary

Colorectal polyp size is related to the risk of exhibiting advanced histological features. Moreover, polyps larger than 10 mm are associated with an elevated risk of metachronous advanced neoplasia and colorectal cancer (CRC). Consequently, accurate measurement of polyp size, especially at the 10 mm threshold is critical for risk stratification and surveillance intervals. Furthermore, polyp size is also important for the choice of the appropriate resection procedures. Underestimation may lead to delayed diagnosis, thereby increasing the risk of colorectal cancer, while overestimation may result in unnecessary surveillance endoscopies.

Detailed Description

Concerns regarding polyp size measurement are increasing. In daily practice, polyp size is mostly estimated based on visual size estimation by the endoscopist, which has proven to be inaccurate, with reported accuracies ranging from 54% to 65%. Furthermore, a prevalent terminal digit preference has been observed, with clustering of size measurements at 5-mm intervals. Additionally, inappropriate surveillance recommendations based on endoscopists' visual assessment have been documented for up to 35% of polyps. Some endoscopists routinely use non-calibrated instruments such as biopsy forceps or polypectomy snares to improve polyp size estimation. However, this approach has proven to be costly and time-consuming. Besides, endoscopes' fisheye lens can lead to size distortions depending on placement of an instrument in the center or periphery of the endoscope image.

AI-assisted systems, such as Virtual Scale Endoscopy (Fujifilm, Tokyo, Japan) and ENDOANGEL-CPS (Renmin Hospital of Wuhan University, Wuhan, China), have been developed to increase the accuracy of polyp size measurement. However, these systems have primarily been tested in video-based studies, which may not accurately reflect real-time conditions. Recently, a new artificial intelligence system (EndoAIM) has been developed that allows polyp size measurement during real-time endoscopy. This system can automatically estimate the diameter of polyps. Preclinical studies have shown promising performance for EndoAIM, with an overall accuracy of 0.98 in discriminating polyp size at the 10 mm threshold. However, its measurement accuracy has not been tested in real patients during real-time endoscopy.

In this research project, we aim to evaluate the measurement accuracy of EndoAIM for estimating colorectal polyp size in real patients during real-time endoscopy.

Conditions

Colonic Polyps; CRC (Colorectal Cancer); Artificial Intelligence (AI)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ENDOAIM used arm

ENDOAIM will be used during withdrawal phase of colonoscopy

Group Type: EXPERIMENTAL

EndoAIM

Intervention Type: DEVICE

EndoAIM will be used during the withdrawal process of the colonoscopy

Interventions

EndoAIM

EndoAIM will be used during the withdrawal process of the colonoscopy

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Subjects are eligible if:

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

2. Aged 18 years older or above;

3. Written informed consent obtained.

Exclusion Criteria

Subjects are excluded if they have:

1. Contraindication to colonoscopy (e.g. intestinal obstruction or perforation)

2. Contraindication or conditions precluding polyp resection (e.g. active gastrointestinal bleeding, uninterrupted anticoagulation or dual antiplatelets)

3. Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Louis Ho Shing Lau

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Louis HS Lau, FRCP

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Central Contacts

Louis HS Lau, FRCP

Role: CONTACT

louishslau@cuhk.edu.hk

26370428

Felix Sia, MSc

Role: CONTACT

felixsia@cuhk.edu.hk

852-2637-0428

Other Identifiers

2024.608

Identifier Type: -

Identifier Source: org_study_id