NBI Versus White Light Endoscopy for Optical Characterization of Neoplastic Polyps in the Colorectum (ADOPTION II)

NBI Versus White Light Endoscopy for Optical Characterization of Neoplastic Polyps in the Colorectum - the ADOPTION II Study

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%.

Study Overview

• Status: Unknown
• Conditions: Colon Adenoma; Colorectal Carcinoma; Hyperplastic Polyp; Serrated Adenoma
• Intervention / Treatment: Device: NBI Function

• Study Type: Observational
• Enrollment (Anticipated): 370

Contacts and Locations

• Study Contact: Name: Peter Klare, MD; Phone Number: +49 89 4140 9340; Email: peter.klare@.tum.de

Study Locations

• Germany
  • Erlangen, Germany, 91054
    • Universitätsklinikum Erlangen, Medizinische Klinik 1
    • Contact: Timo Rath, Professor; Email: Timo.Rath@uk-erlangen.de
  • Stuttgart, Germany, 70376
    • Robert-Bosch-Krankenhaus
    • Contact: Jan Peveling-Oberhag, MD; Email: Jan.Peveling-Oberhag@rbk.de
    • Principal Investigator: Jan Peveling-Oberhag, MD
  • Bayern
    • Munich, Bayern, Germany, 81677
      • Klinik für Innere Medizin II am Klinikum rechts der Isar der Technischen Universität München
      • Contact: Peter Klare, MD; Phone Number: +49 89 4140 9340; Email: peter.klare@tum.de
      • Principal Investigator: Peter Klare, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.; Other Names: NBI Function integrated in the CF-HQ 190 EVIS Exera III Advanced Diagnostic Video Colonoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Investigators: Principal Investigator: Peter Klare, MD, Klinikum Rechts Der Isar Der Technischen Universität München; Study Director: Roland M Schmid, Professor, Klinikum Rechts Der Isar Der Technischen Universität München; Study Chair: Timo Rath, Professor, Universitätsklinikum Erlangen; Study Chair: Jan Peveling-Oberhag, MD, Robert Bosch-Krankenhaus Stuttgart

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2018
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: September 17, 2018
• First Submitted That Met QC Criteria: September 17, 2018
• First Posted (Actual): September 20, 2018

Study Record Updates

• Last Update Posted (Actual): September 20, 2018
• Last Update Submitted That Met QC Criteria: September 17, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Accuracy; Colonoscopy; Adenoma detection rate; Narrow band imaging; Optical biopsy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Adenoma; Polyps
• Other Study ID Numbers: ADOPTION II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No