Clinical trial NCT01262248: Computer-based Classification of Colorectal Polyps Using Narrow-band Imaging
Official title: Computer-based Classification of Small Colorectal Polyps
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Polyps
Keywords: small colorectal polyps
narrow band imaging
vascularization
computer-based classification
Lead sponsor: Tischendorf, Jens, M.D.
Sponsor class: INDIV
First posted: 2010-12-17
Enrollment: 434
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who underwent colonoscopy and colorectal polyps with a size of 10mm or smaller were detected

Brief 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.


Eligibility 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

Primary outcomes:
measure: diagnostic value (sensitivity, specificity, negative predictive value, positive predictive value, accuracy)
timeFrame: 10 months
Secondary outcomes:
measure: interobserver variability
timeFrame: 10 months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Department of Medicine III, University Hospital Aachen (RWTH)
Study officials:
affiliation: Medical Department III, University Hospital Aachen (RWTH), Pauwelsstr. 30, 52074 Aachen
name: Jens Tischendorf, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.