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

Colorectal Carcinoma Clinical Trial

— ADOPTION  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02009774
• Other study ID #: ADOPTION
• Status: Completed
• Phase: N/A
• First received: December 9, 2013
• Last updated: November 5, 2015
• Start date: January 2014
• Est. completion date: May 2015

Study information

• Verified date: August 2015
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colon Adenoma
• Colorectal Carcinoma
• Hyperplasia
• Hyperplastic Polyp

Intervention

Procedure:
• NBI Function

Locations

Country	Name	City	State
Germany	Innere Medizin I am Sana Klinikum Lichtenberg	Berlin
Germany	Medizinische Klinik I des Universitätsklinikums Frankfurt	Frankfurt am Main	Hessen
Germany	II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München	Munich	Bayern

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität München	Olympus

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No