Accuracy of the Optical Diagnosis of Small Colonic Polyps Using the Nice Classification (ADOPTION)
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|ClinicalTrials.gov Identifier: NCT02009774|
Recruitment Status : Completed
First Posted : December 12, 2013
Last Update Posted : November 6, 2015
Adenomas and hyperplastic polyps are polypoid lesion and may occur at any location in the colon. At the present moment, all polyps should be resected endoscopically, although only 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 adenomas and hyperplastic polyps. Some studies have investigated the value of the socalled optical biopsy method. Optical biopsy means the visual assessment of the polyp and the determination of a diagnosis solely on behalf of optical criteria. This method is conducted in real time during colonoscopy. If it can be shown, that endoscopist using optical biopsy 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 hyperplastic polyps and small adenomas and discard them without further assessment by a pathologist. Gastroenterological societies demand for a 90 percent accordance between diagnoses set by endoscopists and pathologists as a prerequisite for the implementation of the optical biopsy method.
In this study we want to proof that the use of a new narrow-band imaging (NBI) tool (Exera III, Olmpus) is capable to rise accuracy of optically ascertained diagnoses of colonic polyps. NBI is a light filter tool which can be activated by pressing a button at the endoscope. NBI function 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 380 patients. Half of the patients will be examined without 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 NICE (NBI International Colorectal Endoscopic) 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 the new NBI tool accuracy (accordance between optical and histopathological diagnosis) can be increased from 78% to 90%.
|Condition or disease||Intervention/treatment|
|Colon Adenoma Colorectal Carcinoma Hyperplastic Polyp||Procedure: NBI Function|
|Study Type :||Observational|
|Actual Enrollment :||380 participants|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||May 2015|
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 WITH THE HELP OF the NBI function of the scope.
Procedure: NBI Function
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): NCT02009774
|II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München|
|Munich, Bayern, Germany, 81677|
|Medizinische Klinik I des Universitätsklinikums Frankfurt|
|Frankfurt am Main, Hessen, Germany, 60590|
|Innere Medizin I am Sana Klinikum Lichtenberg|
|Berlin, Germany, 10365|
|Principal Investigator:||Peter Klare, MD||Klinikum rechts der Isar der Technischen Universität München|
|Study Director:||Stefan von Delius, MD||Klinikum rechts der Isar der Technischen Universität München|
|Study Chair:||Jörg Albert, MD||Medizinische Klinik I University Hospital Frankfurt|
|Study Chair:||Ellen C Nötzel, MD||Innere Medizin I, Sana Klinikum Lichtenberg|