NBI Versus White Light Endoscopy for Optical Characterization of Neoplastic Polyps in the Colorectum (ADOPTION II)
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|ClinicalTrials.gov Identifier: NCT03679429|
Recruitment Status : Not yet recruiting
First Posted : September 20, 2018
Last Update Posted : September 20, 2018
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%.
|Condition or disease||Intervention/treatment|
|Colon Adenoma Colorectal Carcinoma Hyperplastic Polyp Serrated Adenoma||Device: NBI Function|
|Study Type :||Observational|
|Estimated Enrollment :||370 participants|
|Official Title:||NBI Versus White Light Endoscopy for Optical Characterization of Neoplastic Polyps in the Colorectum - the ADOPTION II Study|
|Estimated Study Start Date :||November 2018|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||July 2020|
Patients from the control group will be examined using a CF-HQ 190 EVIS Exera III Advanced Diagnostic Video Colonoscope. If colon polyps are detected optical diagnosis will be determined WITHOUT using the NBI function of the scope.
Patients from the control group will be examined using a CF-HQ 190 EVIS Exera III Advanced Diagnostic Video Colonoscope. If colon polyps are detected optical diagnosis will be determined by using the NBI function of the scope.
Device: NBI Function
In the intervention arm polyps will be optically characterized using the NBI function. The WASP (Workgroup serrAted polypS and Polyposis) classification will be used in order to determine the optical diagnosis.
Other Name: NBI Function integrated in the CF-HQ 190 EVIS Exera III Advanced Diagnostic Video Colonoscope
- Accuracy optical biopsy [ Time Frame: up to 2 weeks (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 2 weeks) ]After obtaining the histopathological diagnosis of resected polyps (approximately 3 days - 2 weeks after colonoscopy ) accuracy of optical diagnosis can be determined
- Adenoma detection rate [ Time Frame: up to 2 weeks (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 2 weeks) ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03679429
|Contact: Peter Klare, MD||+49 89 4140 9340||peter.klare@.tum.de|
|Klinik für Innere Medizin II am Klinikum rechts der Isar der Technischen Universität München|
|Munich, Bayern, Germany, 81677|
|Contact: Peter Klare, MD +49 89 4140 9340 email@example.com|
|Principal Investigator: Peter Klare, MD|
|Universitätsklinikum Erlangen, Medizinische Klinik 1|
|Erlangen, Germany, 91054|
|Contact: Timo Rath, Professor Timo.Rath@uk-erlangen.de|
|Stuttgart, Germany, 70376|
|Contact: Jan Peveling-Oberhag, MD Jan.Peveling-Oberhag@rbk.de|
|Principal Investigator: Jan Peveling-Oberhag, MD|
|Principal Investigator:||Peter Klare, MD||Klinikum rechts der Isar der Technischen Universität München|
|Study Director:||Roland M Schmid, Professor||Klinikum rechts der Isar der Technischen Universität München|
|Study Chair:||Timo Rath, Professor||Universitätsklinikum Erlangen|
|Study Chair:||Jan Peveling-Oberhag, MD||Robert Bosch-Krankenhaus Stuttgart|