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NBI Versus White Light Endoscopy for Optical Characterization of Neoplastic Polyps in the Colorectum (ADOPTION II)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03679429
Recruitment Status : Not yet recruiting
First Posted : September 20, 2018
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Peter Klare, Technische Universität München

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 370 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adoption Endoscopy

Group/Cohort Intervention/treatment
Control 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 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




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:   40 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, Erlangen, Stuttgart). 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 ≥ 40 years
  • written consent given by patient

Exclusion Criteria:

  • age < 40 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 or inflammatory bowel disease
  • 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): NCT03679429


Contacts
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Contact: Peter Klare, MD +49 89 4140 9340 peter.klare@.tum.de

Locations
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Germany
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    peter.klare@tum.de   
Principal Investigator: Peter Klare, MD         
Universitätsklinikum Erlangen, Medizinische Klinik 1
Erlangen, Germany, 91054
Contact: Timo Rath, Professor       Timo.Rath@uk-erlangen.de   
Robert-Bosch-Krankenhaus
Stuttgart, Germany, 70376
Contact: Jan Peveling-Oberhag, MD       Jan.Peveling-Oberhag@rbk.de   
Principal Investigator: Jan Peveling-Oberhag, MD         
Sponsors and Collaborators
Technische Universität München
Investigators
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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

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Responsible Party: Peter Klare, Dr. med. Peter Klare, Technische Universität München
ClinicalTrials.gov Identifier: NCT03679429    
Other Study ID Numbers: ADOPTION II
First Posted: September 20, 2018    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by 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