Colorectal Carcinoma Clinical Trial
Official title:
NBI Versus White Light Endoscopy for Optical Characterization of Neoplastic Polyps in the Colorectum - the ADOPTION II Study
Adenomas, serrated adenomas and hyperplastic polyps are polypoid lesion in the colorectum. At
the present moment, all polyps should be resected endoscopically, although only adenomas and
serrated adenomas, but not hyperplastic polyps have the potential to develop colorectal
cancer. This approach enables the conduction of microscopic investigations of the lesions. By
today, only the pathological diagnosis can distinguish exactly between these three polyp
entities. Some studies have investigated the value of the optical characterization approach
which is based on visual assessment of the polyp' surface structures. Based upon optical
polyp features users are encouraged to predict histopathological polyp diagnoses solely on
behalf of optical or endoscopical criteria. This method is conducted in real time during
colonoscopy. If it could be shown, that endoscopist using the optical characterization
approach are able to predict histopathological diagnoses of colonic polyps sufficiently this
would possibly lead to simplification of diagnostic procedures. For instance, it would be
conceivable to resect small polyps and discard them without further assessment by a
pathologist. One problem in this context is a correct differentiation between hyperplastic
polyps and serrated adenomas. These two polyp entities are known to show similar optical
features. However, while serrated adenomas are premalignant lesions hyperplastic polyps have
benign histology and never develop into cancer. It is therefore important to sufficiently
distinguish hyperplastic polyps from serrated lesions.
In this study we want to investigate whether the use of narrow-band imaging (NBI) would be
capable to rise accuracy of optical polyp predictions compared to standard HD white light
endoscopy. NBI is a light filter tool which can be activated by pressing a button at the
endoscope. The use of NBI leads to an endoscopic picture which appears blue and enables
endoscopists to better assess surface structures and vascular patterns.
In a prospective randomised multicenter setting we plan to conduct colonoscopy in 370
patients. Half of the patients will be examined without the use of NBI (control arm). In
these cases colonoscopists will assess optical diagnosis of polyps without turning on the NBI
tool. If polyps are detected in patients belonging to the intervention arm NBI will be used
and optical diagnosis will be determined using the WASP (Workgroup serrAted polypS and
Polyposis) classification. All polyps will be resected and send to pathology for further
microscopic assessment. After completing the trial we aim to compare accuracy of the optical
diagnosis in both groups. Our hypothesis is, that by using NBI accordance between optical and
histopathological diagnosis can be increased from 80% to 90%.
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