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

Not Applicable

Not yet recruiting

• Conditions: Colonic Polyps; CRC (Colorectal Cancer); Artificial Intelligence (AI)

• Registration Number: NCT06957015
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-09
• Study First Submitted QC: 2025-04-25
• Last Update Submitted: 2025-04-25
• Study Start: 2025-05-01
• Study First Posted: 2025-05-04
• Last Update Posted: 2025-05-04
• Primary Completion: 2027-05-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 278

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the difference in percentage for each measurement in discriminating polyp size at the 10mm threshold	During the colonoscopy	The primary endpoint is the difference in percentage for each measurement in discriminating polyp size at the 10mm threshold

Secondary Outcome Measures

Name	Time	Method
The percentage of correctness of each measurement in discriminating polyp size at the 5 mm threshold	During the colonoscopy	The percentage of correctness of each measurement in discriminating polyp size at the 5 mm threshold
The percentage of correct accuracy of measurement	During the colonoscopy	The percentage of correct accuracy of measurement
Proportion of polyps	During the colonoscopy	Proportion of polyps undersized, oversized or accurately sized within 10%
Proportion of subjects	During the colonoscopy	Proportion of subjects with change in surveillance intervals due to change in polyp size measurement, according to the US Multi-Society Task Force (USMSTF) guideline.