European Serrated Adenoma Classification Score

• Conditions: Colorectal Neoplasms

• Registration Number: NCT03486418
• Lead Sponsor: Technical University of Munich

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-27
• Study First Submitted QC: 2018-03-27
• Study Start: 2018-04-01
• Study First Posted: 2018-04-03
• Status Verified: 2020-09
• Primary Completion: 2020-09-01
• Last Update Submitted: 2020-09-17
• Last Update Posted: 2020-09-18
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Optical diagnosis of each colorectal polyp	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;

Trial Locations

Locations (1)

Klinikum rechts der Isar der TU München; 🇩🇪 Munich, Bayern, Germany