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OpenTrials
Completed

NCT Number: NCT02217449

Virtual Chromoendoscopy for Distal Polyps

To assess the accuracy of predicting histology with virtual chromoendoscopy for distal colorectal polyps according to the ASGE PIVI statement.

Completed

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Key information

Conditions

Colorectal Polyps

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

  • Written informed consent
  • Screening or surveillance colonoscopy

Exclusion criteria

  • history of inflammatory bowel disease
  • poor bowel preparation
  • colectomy
  • anticoagulation
  • polyposis syndrome

Treatment and study plan

Prediction of histology

Other

Primary outcomes

  1. Effectivity of virtual chromoendoscopy

    Time frame: 3 years

    Upon visualization of a polyp in white-light, the location and size (as compared to open biopsy forceps or snare) are noted. Afterwards, virtual chromoendoscopy is used to visualize and enhance the mucosal vascular pattern and the mucosal surface pattern morphology of the polyp. The endoscopist makes 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, the endoscopist is assigning a level of confidence (high or low) to each real time prediction. Afterwards, all polyps are resected using standard techniques and processed for pathological evaluation. Each polyp is assessed by an experienced GI pathologist blinded to the real time prediction of polyp histology. Finally, real time and histological results are compared.

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
First posted
Aug 15, 2014
Registry last updated
Dec 14, 2020

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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