Evalution of Optical Enhancement With Magnification for Polyop Histology

• Conditions: Colorectal Polyps

• Registration Number: NCT02929641
• Lead Sponsor: Shandong University

Brief Summary

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

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).

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-10-08
• Study First Submitted QC: 2016-10-10
• Study First Posted: 2016-10-11
• Status Verified: 2017-12
• Primary Completion: 2017-12
• Last Update Submitted: 2017-12-23
• Last Update Posted: 2017-12-27
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluated the accuracy of i-scan OE system with magnification endoscopy on real-time predicting the pathology types of colorectal polyps.	18 months	To evaluated the accuracy of i-scan OE system with magnification endoscopy on real-time predicting the pathology types of colorectal polyps.

Secondary Outcome Measures

Name	Time	Method
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 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 assess the diagnostic value and inter-observer agreement of OE on post-hoc differentiating pathology of colorectal polyps.	18 months	To assess the diagnostic value and inter-observer agreement of OE on post-hoc differentiating pathology of colorectal polyps.
To assess the value of magnification optical enhancement on classification of colorectal polyps using a deep learning model	18 months	To assess the value of magnification optical enhancement on classification of colorectal polyps using a deep learning model

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China