Evalution of Optical Enhancement With Magnification for Polyop Histology

Study Overview
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Brief Summary
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When a polyp is found, it woulf be recorded by a white-light and OE1 model with magnification for assessing and predicting its histology. After that, its really histology will be reported by an pathologist. When a polyp is found, OE mode 1 with magnification was first used with near focus the polyp and an endoscopist made a real-time prediction of polyp pathology. After that, high-definition mode and OE mode 1 without magnification were used to observe polyp sequencely. The video of all procedure was recorded.

Detailed Description
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After bowel cleansing with 2L polyethylene glycol, patients received colonoscopy under propofol intravenous anesthesia. When a polyp was found, we began to wash it and record the video. OE mode 1 with magnification was first used with near focus the polyp and an endoscopist made a real-time prediction of polyp pathology. After that, high-definition mode and OE mode 1 without magnification were used to observe polyp sequencely. Biopsy of the polyps were taken after observation, and the size of polyps was estimated by the biopsy forceps. The information of patient age, gender polyp morphology and location were recorded. After a video transcoding and clipping, the pathology type of each video clip was predicted by an endoscopist. The sensitivity, specificity, positive predicting value (PPV), negative predicting value (NPV) and accuracy were calculated. The pathology types of polyps were classified by non-neoplastic polyps and neoplastic polyps according to Vienna Classification. Statistics were performed by NCSS 11 and R software (Version 3.3.2).

Official Title
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Evaluation of a New Image-enhanced Endoscopic Technology With Magnification Using I-scan Optical Enhancement for Prediction Colorectal Polyp Histology

Conditions
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Colorectal Polyps

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients will be included if they are found polyps during endoscopy procesure. Exclusion Criteria: Inflammatory bowel disease Biopsies were not available. Unable to provide informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HDWL and OE with magnification<br>The polyps found will be observed by HDWL and OE with magnicication model and recorded. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluated the accuracy of i-scan OE system with magnification endoscopy on real-time predicting the pathology types of colorectal polyps. | To evaluated the accuracy of i-scan OE system with magnification endoscopy on real-time predicting the pathology types of colorectal polyps. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate whether the diagnostic value of OE with magnification can meet the thresholds of resect-and-discard and diagnose-and-leave strategies outlined by Preservation and Incorporation of Valuable Endoscopic Innovations (PIVI) document. | To evaluate whether the diagnostic value of OE with magnification can meet the thresholds of resect-and-discard and diagnose-and-leave strategies outlined by Preservation and Incorporation of Valuable Endoscopic Innovations (PIVI) document. | 18 months | 
| To assess the diagnostic value and inter-observer agreement of OE on post-hoc differentiating pathology of colorectal polyps. | To assess the diagnostic value and inter-observer agreement of OE on post-hoc differentiating pathology of colorectal polyps. | 18 months | 
| To assess the value of magnification optical enhancement on classification of colorectal polyps using a deep learning model | To assess the value of magnification optical enhancement on classification of colorectal polyps using a deep learning model | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Optical Enhancement technology, coloractal polyp prediction