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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01262248
Other study ID # Ti-NBI
Secondary ID
Status Completed
Phase N/A
First received December 15, 2010
Last updated June 15, 2011
Start date May 2010
Est. completion date March 2011

Study information

Verified date June 2011
Source Tischendorf, Jens, M.D.
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 434
Est. completion date March 2011
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Department of Medicine III, University Hospital Aachen (RWTH) Aachen

Sponsors (1)

Lead Sponsor Collaborator
Tischendorf, Jens, M.D.

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Ignjatovic A, East JE, Suzuki N, Vance M, Guenther T, Saunders BP. Optical diagnosis of small colorectal polyps at routine colonoscopy (Detect InSpect ChAracterise Resect and Discard; DISCARD trial): a prospective cohort study. Lancet Oncol. 2009 Dec;10(12):1171-8. doi: 10.1016/S1470-2045(09)70329-8. Epub 2009 Nov 10. — View Citation

Tischendorf JJ, Schirin-Sokhan R, Streetz K, Gassler N, Hecker HE, Meyer M, Tacke F, Wasmuth HE, Trautwein C, Winograd R. Value of magnifying endoscopy in classifying colorectal polyps based on vascular pattern. Endoscopy. 2010 Jan;42(1):22-7. doi: 10.1055/s-0029-1215268. Epub 2009 Nov 6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary diagnostic value (sensitivity, specificity, negative predictive value, positive predictive value, accuracy) 10 months No
Secondary interobserver variability 10 months No
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