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JOURNAL ONKOLOGIE – STUDIE
ADOPTION II

NBI Versus White Light Endoscopy for Optical Characterization of Neoplastic Polyps in the Colorectum

Noch nicht rekrutierend

NCT-Nummer:
NCT03679429

Studienbeginn:
November 2018

Letztes Update:
20.09.2018

Wirkstoff:
-

Indikation (Clinical Trials):
Polyps, Adenoma, Colorectal Neoplasms, Hyperplasia

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Technische Universität München

Collaborator:
-

Studienleiter

Peter Klare, MD
Principal Investigator
Klinikum rechts der Isar der Technischen Universität München
Roland M Schmid, Professor
Study Director
Klinikum rechts der Isar der Technischen Universität München
Timo Rath, Professor
Study Chair
Universitätsklinikum Erlangen
Jan Peveling-Oberhag, MD
Study Chair
Robert Bosch-Krankenhaus Stuttgart

Kontakt

Studienlocations
(3 von 3)

Klinik für Innere Medizin II am Klinikum rechts der Isar der Technischen Universität München
81677 Munich
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Peter Klare, MD
Phone: +49 89 4140 9340
E-Mail: peter.klare@tum.de
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Universitätsklinikum Erlangen, Medizinische Klinik 1
91054 Erlangen
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Timo Rath, Professor
E-Mail: Timo.Rath@uk-erlangen.de
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Brustzentrum Robert-Bosch-Krankenhaus
Auerbachstraße 110
70376 Stuttgart
DeutschlandNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Jan Peveling-Oberhag, MD
E-Mail: Jan.Peveling-Oberhag@rbk.de
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Studien-Informationen

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%.

Ein-/Ausschlusskriterien

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)

Studien-Rationale

Primary outcome:

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:

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))

Studien-Arme

  • 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.

Geprüfte Regime

  • NBI Function (NBI Function integrated in the CF-HQ 190 EVIS Exera III Advanced Diagnostic Video Colonoscope):
    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.

Quelle: ClinicalTrials.gov


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