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Accuracy of the Optical Diagnosis of Small Colonic Polyps Using the Nice Classification (ADOPTION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02009774
Recruitment Status : Completed
First Posted : December 12, 2013
Last Update Posted : November 6, 2015
Sponsor:
Collaborator:
Olympus
Information provided by (Responsible Party):
Dr. Peter Klare, Technische Universität München

Brief Summary:

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

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Study Type : Observational
Actual Enrollment : 380 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : January 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Controll group
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.
Intervention
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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
Colon polyps


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients will be recruited at the three participating study centers (Munich, Frankfurt, Berlin). Two of the three centers are tertiary referral-centres whereas the last one is a major regional hospital. All patients undergo colonoscopy for medical indications.
Criteria

Inclusion Criteria:

  • medical indication for colonoscopy
  • age >18 years
  • written consent given by patient

Exclusion Criteria:

  • age < 18 years
  • patients denying written consent
  • pregnant women
  • ASA class IV, V and VI
  • known contraindication for polyp resection
  • indication for colonoscopy: preknown adenoma/polyp/carcinoma
  • indication for colonoscopy: emergency (e.g. severe rectal bleeding)

Information from the National Library of Medicine

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


Locations
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Germany
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
Sponsors and Collaborators
Technische Universität München
Olympus
Investigators
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Peter Klare, MD, Technische Universität München
ClinicalTrials.gov Identifier: NCT02009774    
Other Study ID Numbers: ADOPTION
First Posted: December 12, 2013    Key Record Dates
Last Update Posted: November 6, 2015
Last Verified: August 2015
Keywords provided by Dr. Peter Klare, Technische Universität München:
Colonoscopy
Adenoma detection rate
Narrow band imaging
Optical biopsy
Accuracy
Additional relevant MeSH terms:
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Adenoma
Colorectal Neoplasms
Polyps
Pathological Conditions, Anatomical
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases