Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Virtual Chromoendoscopy for Distal Polyps

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02217449
Recruitment Status : Completed
First Posted : August 15, 2014
Last Update Posted : December 14, 2020
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

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

Condition or disease Intervention/treatment
Colorectal Polyps Other: Prediction of histology

Layout table for study information
Study Type : Observational
Actual Enrollment : 230 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : January 2011
Actual Primary Completion Date : August 2014

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



Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients undergoing screeining or surveillance colonoscopy
Criteria

Inclusion Criteria:

  • Written informed consent
  • Screening or surveillance colonoscopy

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02217449


Locations
Layout table for location information
Germany
University Hospital Erlangen
Erlangen, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT02217449    
Other Study ID Numbers: HN-0010
First Posted: August 15, 2014    Key Record Dates
Last Update Posted: December 14, 2020
Last Verified: December 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Polyps
Pathological Conditions, Anatomical