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Clinical Trials/NCT03118856
NCT03118856
Completed
Not Applicable

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

University of Erlangen-Nürnberg Medical School1 site in 1 country230 target enrollmentFebruary 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Polyp
Sponsor
University of Erlangen-Nürnberg Medical School
Enrollment
230
Locations
1
Primary Endpoint
Accuracy of predicting histology with EC
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
February 1, 2017
End Date
May 31, 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Erlangen-Nürnberg Medical School
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patients undergoing screening or surveillance colonoscopy
  • written informed consent

Exclusion Criteria

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

Outcomes

Primary Outcomes

Accuracy of predicting histology with EC

Time Frame: 1 year

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.

Study Sites (1)

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