Clinical trial NCT05414383: A Prospective Study to Evaluate the Diagnostic Accuracy of Computer-aided Diagnosis (CADx) System in Real-time Characterization of Colorectal Neoplasia
Official title: A Prospective Study to Evaluate the Diagnostic Accuracy of Computer-aided Diagnosis (CADx) System in Real-time Characterization of Colorectal Neoplasia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Colorectal Neoplasms
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Nanfang Hospital, Southern Medical University
name: University College, London
First posted: 2022-06-10
Enrollment: 510
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with colorectal neoplasia

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.

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

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: During the colonoscopy
Secondary outcomes:
measure: Sensitivity
timeFrame: During the colonoscopy
measure: Specificity
timeFrame: During the colonoscopy
measure: Positive predictive value
timeFrame: During the colonoscopy
measure: Negative predictive value
timeFrame: During the colonoscopy
measure: Diagnostic time
timeFrame: During the colonoscopy
Other outcomes:
Locations:
Study officials:
References: