Electronic Chromoendoscopy for Polyp Characterization

Real-time Assessment of the Histology of Colorectal Polyps Using Electronic Chromoendoscopy

To assess the accuracy of predicting histology of colorectal polyps with electronic chromoendoscopy.

Study Overview

• Status: Completed
• Conditions: Colorectal Polyp
• Intervention / Treatment: Diagnostic test: Prediction of Histology

• Study Type: Observational
• Enrollment (Actual): 230

Contacts and Locations

Study Locations

• Germany
  • Erlangen, Germany, 91054
    • University Hospital Erlangen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergoing screening or surveillance colonoscopy

Description

Inclusion Criteria:

• patients undergoing screening or surveillance colonoscopy
• written informed consent

Exclusion Criteria:

• inadequate bowel preparation
• polyposis syndromes
• history of colectomy
• use of anticoagulants

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HD-WLE; Intervention: Prediction of polyp histology with HD-WLE	Diagnostic test: Prediction of Histology; The accuracy of predicting the histology of colorectal polyps will be assessed with HD-WLE and EC
EC; Intervention: Prediction of polyp histology with EC	Diagnostic test: Prediction of Histology; The accuracy of predicting the histology of colorectal polyps will be assessed with HD-WLE and EC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of predicting histology with EC	Polyps will be visualized in white-light and the location and size will be noted. Afterwards, electronic chromoendoscopy will be used to visualize and enhance the mucosal vascular pattern and the mucosal surface pattern morphology of the polyp. The endoscopist will then make a real time assessment of each polyp according to size, shape, Paris classification and surface characteristics including pit pattern and mucosal vascular pattern morphology, colour, and type of depression. Further, a level of confidence (high or low) will be made for the real time histology prediction. Finally, all polyps will be removed using standard techniques and processed for pathological evaluation and real time and histological results will be compared.	1 year

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Investigators: Principal Investigator: Timo Rath, MD, University Hospital Erlangen

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): February 28, 2018
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: April 13, 2017
• First Submitted That Met QC Criteria: April 13, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 25, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps
• Other Study ID Numbers: TR-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No