Virtual Chromoendoscopy for Distal Polyps

December 10, 2020 updated by: University of Erlangen-Nürnberg Medical School
To assess the accuracy of predicting histology with virtual chromoendoscopy for distal colorectal polyps according to the ASGE PIVI statement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

230

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing screeining or surveillance colonoscopy

Description

Inclusion Criteria:

  • Written informed consent
  • Screening or surveillance colonoscopy

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HD
Prediction of histology
Other: Prediction of histology
Virtual Chromoendoscopy
Prediction of histology
Other: Prediction of histology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

August 8, 2014

First Submitted That Met QC Criteria

August 13, 2014

First Posted (Estimate)

August 15, 2014

Study Record Updates

Last Update Posted (Actual)

December 14, 2020

Last Update Submitted That Met QC Criteria

December 10, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HN-0010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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