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Clinical Trials/NCT03486418
NCT03486418
Unknown
Not Applicable

Development of an Endoscopic Classification Score System for Serrated Adenomas in the Colorectum

Technical University of Munich1 site in 1 country250 target enrollmentApril 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Neoplasms
Sponsor
Technical University of Munich
Enrollment
250
Locations
1
Primary Endpoint
Optical diagnosis of each colorectal polyp
Last Updated
5 years ago

Overview

Brief Summary

The aim of the study is to develop a score system in order to differentiate adenomatous polyps, hyperplastic polyps and serrated adenomas on the basis of optical features. Endoscopic images of colorectal polyps will be collected from a prospectively managed database. Histopathological diagnoses are available for all polyps. Histopathological diagnoses serve as gold standard in this study.

In the first phase of the study optical features of serrated adenomas are extracted from the database. Discriminators are then defined on the basis of the extracted features. In the second phase a test set of high quality pictures are provided to both novices and experts of colorectal endoscopy. Participants are asked to use the above named discriminators in order to rate pictures and to classify polyps into three classes (adenomatous polyps, hyperplastic polyps and serrated adenomas). In the third phase of the study accuracy of optical bases diagnoses is calculated by comparing optically derived diagnoses with histopathological diagnoses (gold standard).

Registry
clinicaltrials.gov
Start Date
April 1, 2018
End Date
April 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Technical University of Munich
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • indication for colonoscopy
  • patients \>= 18 years

Exclusion Criteria

  • pregnant women
  • indication for colonoscopy: inflammatory bowel disease
  • indication for colonoscopy: polyposis syndrome
  • indication for colonoscopy: emergency colonoscopy e.g. acute bleeding
  • contraindication for polyp resection e.g. patients on warfarin

Outcomes

Primary Outcomes

Optical diagnosis of each colorectal polyp

Time Frame: Participants will be followed for the duration of the study an expected average of 6 month

The predicted polyp histology (determined according to optical polyp features) will be assessed; the predicted diagnosis will be compared with the histopathological diagnosis (gold standard) after;

Study Sites (1)

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