Prince of Wales Hospital
Shatin, Hong Kong
Location status: Recruiting
NCT Number: NCT06957015
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Shatin, Hong Kong
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Subjects are eligible if:
Exclusion criteria
Subjects are excluded if they have:
EndoAIM will be used during the withdrawal process of the colonoscopy
Time frame: During the colonoscopy
The primary endpoint is the difference in percentage for each measurement in discriminating polyp size at the 10mm threshold
Time frame: During the colonoscopy
The percentage of correctness of each measurement in discriminating polyp size at the 5 mm threshold
Time frame: During the colonoscopy
The percentage of correct accuracy of measurement
Time frame: During the colonoscopy
Proportion of polyps undersized, oversized or accurately sized within 10%
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Felix Sia, MSc
CONTACT
Louis HS Lau, FRCP
CONTACT
Chinese University of Hong Kong
Other
Acronym: EndoAIM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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