Evalution of Optical Enhancement With Magnification for Polyop Histology

Colorectal Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02929641
• Other study ID #: 2016SDU-QILU-14
• Status: Recruiting
• Phase: N/A
• First received: October 8, 2016
• Last updated: December 23, 2017
• Start date: August 2016
• Est. completion date: February 2018

Study information

• Verified date: December 2017
• Source: Shandong University
• Contact: Yanqing Li, MD,PhD
• Phone: 86-531-82169236
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Polyps
• Polyps

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

References & Publications (2)

Basford PJ, Longcroft-Wheaton G, Higgins B, Bhandari P. High-definition endoscopy with i-Scan for evaluation of small colon polyps: the HiSCOPE study. Gastrointest Endosc. 2014 Jan;79(1):111-8. doi: 10.1016/j.gie.2013.06.013. Epub 2013 Jul 17. — View Citation

Neumann H, Fujishiro M, Wilcox CM, Mönkemüller K. Present and future perspectives of virtual chromoendoscopy with i-scan and optical enhancement technology. Dig Endosc. 2014 Jan;26 Suppl 1:43-51. doi: 10.1111/den.12190. Epub 2013 Oct 23. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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