Evalution of Optical Enhancement With Magnification for Polyop Histology

NCT02929641 | Unknown

• 1 other identifier: 2016SDU-QILU-14
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Polyps

Keywords

Optical Enhancement technology; coloractal polyp prediction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

  18 months

• To assess the value of magnification optical enhancement on classification of colorectal polyps using a deep learning model

  18 months

Study Arms (1)

HDWL and OE with magnification

The polyps found will be observed by HDWL and OE with magnicication model and recorded.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who experence an examation of coloscopy found polyps.

You may qualify if:

• Patients will be included if they are found polyps during endoscopy procesure.

You may not qualify if:

• Inflammatory bowel disease
• Biopsies were not available.
• Unable to provide informed consent.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Related 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.

  PMID: 23871094 RESULT

• Neumann H, Fujishiro M, Wilcox CM, Monkemuller 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.

  PMID: 24373000 RESULT

Study Officials

• Yanqing Li, MD,PhD

  Qilu Hospital of Shandong University

  STUDY DIRECTOR

Central Study Contacts

Yanqing Li, MD,PhD

CONTACT

86-531-82169236; liyanqing@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 8, 2016
• First Posted: October 11, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2018
• Last Updated: December 27, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)