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

Colorectal Polyps Clinical Trial

Official title:

Computer-based Classification of Small Colorectal Polyps

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01262248
• Other study ID #: Ti-NBI
• 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

• Colorectal Polyps
• Polyps

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