Clinical Trial: Computer Assisted Optical Assessment of Small Colorectal Polyps

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title:

Brief Summary:

The aim of the study is to develop a computer program which is able to distinguish between adenomatous and non- adenomatous polyps on the basis of optical features of the polyps. Still images of polyps (< 10 mm of size) will be collected during routine colonoscopy procedures. All polyps will be resected endoscopically so that histopathological diagnoses (gold standard) can be notified.

In the validation phase of the study a computer program will be established which aims to distinguish between adenomatous and non- adenomatous polyps on the basis of optical features derived from still images. The program will operated using the the random forest learning method. Afterwards, in the testing phase of the study, still images of 100 polyps (not used in the validation phase) will be presented to the computer program. The establishment of a well- functioning computer program is the primary aim of the study.


Detailed Summary:

Adenomas are polyps of the colorectum that have the potential to develop into colon cancer [1]. However, some adenomas never become malignant and if they do, progression from adenoma into cancer usually takes a long time. As a result, screening colonoscopy programs were established in order to detect and resect adenomas at an early stage [2]. After resection, polyps should be sent to pathology in order to make a histological diagnosis. Not every colorectal polyp has adenomatous histology. Approximately 40-50% of all polyps contain other benign histology (e.g. hyperplastic or inflammatory polyps). These polyps do not bear the risk of colon cancer.

The implementation of screening programs has led to increasing numbers of colonoscopies in the last years [3]. This approach naturally implies higher amounts of detected polyps. The removal of these polyps and consultation of a pathologist in order to make a diagnosis is time consuming and expensive. An optical- based prediction of polyp histology (adenomatous versus non- adenomatous) would enable endoscopists to save money and to inform patients faster about examination results. The approach of predicting polyp histology on the basis of optical features is called the "optical biopsy" method. The prediction is made by the endoscopists during real-time colonoscopy. The aim of this strategy is to make an optical diagnosis which enables users to resect polyps without sending the specimen to pathology. Narrow Band Imaging (NBI) is a light-filter device which can be switched on during colonoscopy. NBI is useful to better display vascular patterns of the colon mucosa. It has been shown that the use of NBI can facilitate optical classification of colorectal polyps [5]. A NBI- based classification schemes exists which can be used to assign polyps into specific polyp categories (adenomatous versus non- adenomatous) [6].

Sponsor: Technische Universität München

Current Primary Outcome: Assessment of the computer- made optical diagnosis of each colorectal polyp [ Time Frame: up to 2 weeks ]

The predicted polyp histology (made optically by the computer program) will be assessed; the predicted diagnosis will be compared with the histopathological diagnosis (gold standard) after resection of the polyp;

(participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 2 weeks)] [Safety Issue: No] After obtaining the histopathological diagnosis of resected polyps (approximately 3 days - 2 weeks)



Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Technische Universität München

Dates:
Date Received: August 8, 2015
Date Started: August 2015
Date Completion: August 2017
Last Updated: April 8, 2017
Last Verified: April 2017