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

This study has been completed.
Sponsor:
Information provided by:
Tischendorf, Jens, M.D.
ClinicalTrials.gov Identifier:
NCT01262248
First received: December 15, 2010
Last updated: June 15, 2011
Last verified: June 2011
History of Changes
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • interobserver variability [ Time Frame: 10 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: December 15, 2010
Last Updated: June 15, 2011
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Polyps
Colonic Polyps
Pathological Conditions, Anatomical
Intestinal Polyps

ClinicalTrials.gov processed this record on May 16, 2013