Klinik für Innere Medizin II am Klinikum rechts der Isar der Technischen Universität München München, Deutschland Germany 81675 Munich (Bayern) GermanyRekrutierend» Google-Maps Ansprechpartner: Peter Klare, MD Phone: + 49 89 4140 Phone (ext.): 9340 E-Mail: peter.klare@tum.de» Ansprechpartner anzeigen
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 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].
Prior to the implementation of the optical classification approach for routine use in
endoscopy it is necessary to proof its feasibility and accuracy [7]. Otherwise the approach
would entail the risk of wrong diagnoses which could lead to wrong recommendations on further
diagnostic or therapeutic steps.
Until now, some clinical trials have shown good accuracy for the optical biopsy method [5].
However, there is growing evidence that optical biopsy does not yet meet demanded accuracy
thresholds [8]. The aim of our study is to create a computer program that is able to
distinguish between adenomas, serrated adenomas and hyperplastic polyps. Video sequences of
colorectal polyps will be used for machine learning (validation phase). Afterwards a set of
100 videos will be used to test whether the computer program is able to distinguish between
adenomatous and non- adenomatous polyps (primary endpoint). Statistical measures (accuracy,
sensitivity, specificity) will be calculated. The 100 videos will also be presented to human
experts who will also predict polyp diagnoses based on optical features. Comparing the
accuracy of optical predictions made by the computer and by human experts will be another
endpoint of the study.
1. 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)
Videos of polyps, resection of polyps: Ther is no study specific intervention. Video sequences will be taken if polyps are found in the colon. Polyps will then be resected routinely.
Quelle: ClinicalTrials.gov
Sie können folgenden Inhalt einem Kollegen empfehlen:
"Computer Assisted Detection & Selection of Serrated Adenomas and Neoplastic Polyps - a New Clinical DRAft"
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