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

NCT02009774 | Completed

• 1 other identifier: ADOPTION
• Study Type: observational
• Target: 380
• Locations: 1 country
• Sites: 3

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

Keywords

Colonoscopy; Adenoma detection rate; Narrow band imaging; Optical biopsy; Accuracy

Outcome Measures

Primary Outcomes (1)

• Accuracy optical biopsy

  After obtaining the histopathological diagnosis of resected polyps (approximately 3 days - 2 weeks after colonoscopy ) accuracy of optical diagnosis can be determined

  up to 2 weeks (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 2 weeks)

Secondary Outcomes (1)

• Adenoma detection rate

  up to 2 weeks (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 2 weeks)

Study Arms (2)

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

Interventions

NBI Function PROCEDURE

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

Intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Technical University of Munich: lead
• Olympus: collaborator

Study Sites (3)

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

Munich, Bavaria, 81677, Germany

Location

Medizinische Klinik I des Universitätsklinikums Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Innere Medizin I am Sana Klinikum Lichtenberg

Berlin, State of Berlin, 10365, Germany

Location

Related Publications (1)

• 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.

  PMID: 27448051 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Colon polyps

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Peter Klare, MD

  Klinikum rechts der Isar der Technischen Universität München

  PRINCIPAL INVESTIGATOR

• Stefan von Delius, MD

  Klinikum rechts der Isar der Technischen Universität München

  STUDY DIRECTOR

• Jörg Albert, MD

  Medizinische Klinik I University Hospital Frankfurt

  STUDY CHAIR

• Ellen C Nötzel, MD

  Innere Medizin I, Sana Klinikum Lichtenberg

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 12, 2013
• Study Start: January 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2015
• Last Updated: November 6, 2015

Record last verified: 2015-08

Locations

DE (3)