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Computer-based Classification of Colorectal Polyps Using Narrow-band Imaging

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01262248
First Posted: December 17, 2010
Last Update Posted: June 16, 2011
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.
Information provided by:
Tischendorf, Jens, M.D.
  Purpose
Recent studies have shown that narrow-band imaging (NBI) is a powerful diagnostic tool for the differentiation between neoplastic and non-neoplastic colorectal polyps. The aim of the present study is to develop and evaluate a computer-based method for automated classification of small colorectal polyps on the basis of vascularization features.In a prospective study 207 polyps with a size of 10mm or smaller should be detected by a zoom NBI colonoscopy. These polyps were imaged and subsequently removed for histological analysis. the polyp images were analyzed by a computer algorithm. The proposed computer-based method consists of several steps: preprocessing, vessel segmentation, feature extraction and classification. The results of the automatic classification (sensitivity, specificity, negative predictive value, positive predictive value and accuracy)were compared to those of human observers, who were blinded to the histological gold standard.

Condition
Colorectal Polyps

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Computer-based Classification of Small Colorectal Polyps

Further study details as provided by Tischendorf, Jens, M.D.:

Primary Outcome Measures:
  • diagnostic value (sensitivity, specificity, negative predictive value, positive predictive value, accuracy) [ Time Frame: 10 months ]

Secondary Outcome Measures:
  • interobserver variability [ Time Frame: 10 months ]

Enrollment: 434
Study Start Date: May 2010
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients with colorectal polyps

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients who underwent colonoscopy and colorectal polyps with a size of 10mm or smaller were detected
Criteria

Inclusion Criteria:

  • All patients who did not meet the exclusion criteria were included in the study

Exclusion Criteria:

  • Patients with chronic inflammatory bowel disease, adenomatosis coli, coagulopathy, insufficient bowel preparation, or previous colonoscopy within the last 3 years; age under 18 years; no written informed consent for participation in the study
  Contacts and Locations
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): NCT01262248


Locations
Germany
Department of Medicine III, University Hospital Aachen (RWTH)
Aachen, Germany, 52074
Sponsors and Collaborators
Tischendorf, Jens, M.D.
Investigators
Principal Investigator: Jens Tischendorf, M.D. Medical Department III, University Hospital Aachen (RWTH), Pauwelsstr. 30, 52074 Aachen
  More Information

Publications:
Responsible Party: Tischendorf, Jens, M.D., Department of Medicine III, University of Aachen (RWTH)
ClinicalTrials.gov Identifier: NCT01262248     History of Changes
Other Study ID Numbers: Ti-NBI
First Submitted: December 15, 2010
First Posted: December 17, 2010
Last Update Posted: June 16, 2011
Last Verified: June 2011

Keywords provided by Tischendorf, Jens, M.D.:
small colorectal polyps
narrow band imaging
vascularization
computer-based classification

Additional relevant MeSH terms:
Polyps
Pathological Conditions, Anatomical