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OpenTrials
Completed

NCT Number: NCT03118856

Electronic Chromoendoscopy for Polyp Characterization

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

Completed

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Key information

Conditions

Colorectal Polyp

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Erlangen

Erlangen, 91054, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients undergoing screening or surveillance colonoscopy
  • written informed consent

Exclusion criteria

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

Treatment and study plan

Prediction of Histology

Diagnostic Test

The accuracy of predicting the histology of colorectal polyps will be assessed with HD-WLE and EC

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 18, 2017
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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