Development of an Endoscopic Classification Score System for Serrated Adenomas in the Colorectum
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Optical diagnosis of each colorectal polyp
Study 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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
Secondary Outcomes
No secondary outcomes reported