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

NCT03679429 | Unknown

• 1 other identifier: ADOPTION II
• Study Type: observational
• Target: 370
• Locations: 1 country
• Sites: 3

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%.

Conditions

Colon Adenoma; Colorectal Carcinoma; Hyperplastic Polyp; Serrated Adenoma

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)

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

Interventions

NBI Function DEVICE

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.

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

Intervention

Eligibility Criteria

• Age: 40 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, 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.

You may qualify if:

• medical indication for colonoscopy
• age ≥ 40 years
• written consent given by patient

You may not qualify if:

• 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)

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (3)

Klinik für Innere Medizin II am Klinikum rechts der Isar der Technischen Universität München

Munich, Bavaria, 81677, Germany

Location

Universitätsklinikum Erlangen, Medizinische Klinik 1

Erlangen, 91054, Germany

Location

Robert-Bosch-Krankenhaus

Stuttgart, 70376, Germany

Location

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

• Roland M Schmid, Professor

  Klinikum rechts der Isar der Technischen Universität München

  STUDY DIRECTOR

• Timo Rath, Professor

  Universitätsklinikum Erlangen

  STUDY CHAIR

• Jan Peveling-Oberhag, MD

  Robert Bosch-Krankenhaus Stuttgart

  STUDY CHAIR

Central Study Contacts

Peter Klare, MD

CONTACT

+49 89 4140 9340; peter.klare@.tum.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Peter Klare

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 20, 2018
• Study Start: November 1, 2018
• Primary Completion: May 1, 2020
• Study Completion: July 1, 2020
• Last Updated: September 20, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)