Accuracy of the Optical Diagnosis of Small Colonic Polyps Using the Nice Classification

NCT ID: NCT02009774

Last Updated: 2015-11-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 380 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-05-31

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%.

Conditions

Colon Adenoma; Colorectal Carcinoma; Hyperplastic Polyp

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

NBI Function

Intervention Type: PROCEDURE

Interventions

NBI Function

Intervention Type: PROCEDURE

Other Intervention Names

NBI Function integrated in the CF-HQ 190 EVIS Exera III Advanced Diagnostic Video Colonoscope

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Olympus

INDUSTRY

Sponsor Role: collaborator

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Dr. Peter Klare

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Klare, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum rechts der Isar der Technischen Universität München

Stefan von Delius, MD

Role: STUDY_DIRECTOR

Klinikum rechts der Isar der Technischen Universität München

Jörg Albert, MD

Role: STUDY_CHAIR

Medizinische Klinik I University Hospital Frankfurt

Ellen C Nötzel, MD

Role: STUDY_CHAIR

Innere Medizin I, Sana Klinikum Lichtenberg

Locations

II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München

Munich, Bavaria, Germany

Medizinische Klinik I des Universitätsklinikums Frankfurt

Frankfurt am Main, Hesse, Germany

Innere Medizin I am Sana Klinikum Lichtenberg

Berlin, State of Berlin, Germany

Countries

Germany

References

Klare P, Haller B, Wormbt S, Notzel E, Hartmann D, Albert J, Hausmann J, Einwachter H, Weber A, Abdelhafez M, Schmid RM, von Delius S. Narrow-band imaging vs. high definition white light for optical diagnosis of small colorectal polyps: a randomized multicenter trial. Endoscopy. 2016 Oct;48(10):909-15. doi: 10.1055/s-0042-110650. Epub 2016 Jul 22.

Reference Type: DERIVED

PMID: 27448051 (View on PubMed)

Other Identifiers

ADOPTION

Identifier Type: -

Identifier Source: org_study_id