Non-magnified NBI in Barrett's Oesophagus Neoplasia Detection and Delineation

NCT04621474 | Unknown

• 1 other identifier: NiBOD
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopy plays a pivotal role in the management (diagnosis and treatment) of Barrett's related neoplasia. The standard endoscopy is generally done under white light, which is known to be imperfect in detecting early neoplastic lesion. Narrow band imaging (NBI) improves definition of the superficial morphology and vasculature of GI mucosa. Some studies have shown the potential to improve diagnostic accuracy and reduce the number of biopsies required for Barrett's related neoplasia. This can ultimately improve the cost-effectiveness of endoscopic surveillance. The ability to discriminate between healthy and diseased tissue also makes NBI a useful technique for the delineation of lesions to treat with endoscopic mucosal resection (EMR). However not all studies provide evidence of diagnostic utility. Also the majority of these studies have been conducted by expert endoscopists, which makes the results difficult to extend to general endoscopy practice. The limited number of Barrett's specialists in certain areas of the country validates the need for a study to investigate whether there is an objective improvement in detection and delineation of Barrett's neoplastic lesions by less experienced observers. The aim of this study was to determine the utility of non-magnified NBI in non-expert identification of lesions as compared to expert endoscopists as well as the inter-observer agreement among endoscopists on WLE and NBI.

Conditions

Barrett Esophagus

Outcome Measures

Primary Outcomes (2)

• Lesion identification

  Identification of lesions by non Barrett's expert endoscopists on WLE and non-magnified NBI as compared to expert endoscopists

  1 year

• Inter-observer agreement

  Inter-observer agreement among endoscopists on WLE and NBI

  1 year

Secondary Outcomes (1)

• Preferred imaging modality

  1 year

Interventions

Narrow band imaging (NBI) DIAGNOSTIC_TEST

Narrow-band imaging uses specific light wavelengths of 415 nm (blue) and 540 nm (green) due to a special filter which is electronically activated by a switch in the endoscope.

Also known as: Non-magnified white-light endoscopy (WLE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surveillance for Barrett's oesophagus or work up for Barrett's related neoplasia

You may qualify if:

• Diagnosed with dysplastic or non-dysplastic BO at least C1 or M2 in length

You may not qualify if:

• Reflux oesophagitis (Los Angeles grade ≥C);

Sponsors & Collaborators

• University of Cambridge: lead

Study Sites (1)

MRC Cancer Unit

Cambridge, CB2 0XZ, United Kingdom

RECRUITING

Related Publications (5)

• Sami SS, Subramanian V, Butt WM, Bejkar G, Coleman J, Mannath J, Ragunath K. High definition versus standard definition white light endoscopy for detecting dysplasia in patients with Barrett's esophagus. Dis Esophagus. 2015 Nov-Dec;28(8):742-9. doi: 10.1111/dote.12283. Epub 2014 Sep 10.

  PMID: 25209721 BACKGROUND

• Swager AF, Curvers WL, Bergman JJ. Diagnosis by Endoscopy and Advanced Imaging of Barrett's Neoplasia. Adv Exp Med Biol. 2016;908:81-98. doi: 10.1007/978-3-319-41388-4_5.

  PMID: 27573768 BACKGROUND

• Sharma P, Hawes RH, Bansal A, Gupta N, Curvers W, Rastogi A, Singh M, Hall M, Mathur SC, Wani SB, Hoffman B, Gaddam S, Fockens P, Bergman JJ. Standard endoscopy with random biopsies versus narrow band imaging targeted biopsies in Barrett's oesophagus: a prospective, international, randomised controlled trial. Gut. 2013 Jan;62(1):15-21. doi: 10.1136/gutjnl-2011-300962. Epub 2012 Feb 7.

  PMID: 22315471 RESULT

• Yoshida T, Inoue H, Usui S, Satodate H, Fukami N, Kudo SE. Narrow-band imaging system with magnifying endoscopy for superficial esophageal lesions. Gastrointest Endosc. 2004 Feb;59(2):288-95. doi: 10.1016/s0016-5107(03)02532-x.

  PMID: 14745410 RESULT

• de Groof AJ, Swager AF, Pouw RE, Weusten BLAM, Schoon EJ, Bisschops R, Pech O, Meining A, Neuhaus H, Curvers WL, Bergman JJGHM. Blue-light imaging has an additional value to white-light endoscopy in visualization of early Barrett's neoplasia: an international multicenter cohort study. Gastrointest Endosc. 2019 Apr;89(4):749-758. doi: 10.1016/j.gie.2018.10.046. Epub 2018 Nov 9.

  PMID: 30419218 RESULT

MeSH Terms

Conditions

Barrett Esophagus

Interventions

Narrow Band Imaging

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Massimiliano di Pietro, MD

  MRC Cancer Unit.University of Cambridge.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Massimiliano di Pietro, MD

CONTACT

01223763349; md460@mrc-cu.cam.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinician Scientist

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 9, 2020
• Study Start: April 8, 2019
• Primary Completion: April 8, 2021
• Study Completion: April 8, 2021
• Last Updated: November 9, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)