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

NCT ID: NCT04621474

Last Updated: 2020-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-08

Study Completion Date

2021-04-08

Brief Summary

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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.

Detailed Description

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Matched non-magnified white-light endoscopy (WLE) and narrow band imaging (NBI) images of Barrett's oesophagus with and without lesions from the same level will be obtained prospectively. Lesions will be delineated by 3 expert endoscopists and the overlap between all delineations for each image, regarded as the "sweet spot", will be used as the gold standard. The images will then be assessed by a group of non-expert endoscopists (trainees and nurse endoscopists) as well as senior endoscopists with no interest in Barrett's. First, white light images will be assessed, followed by a wash-out period and then NBI. Assessments will be carried out using a computer application designed in MATLAB. Observers will be also asked to complete the following 1) Paris classification of lesion 2) delineation of the lesion on the screen 3) rate the ability to delineate the lesion for each of the two respective imaging modalities (using a Visual analog scale (VAS score 1-10), 4) choice a single point for virtual diagnostic biopsy. Thus, the quantitative interobserver agreement of the delineations for WLE and NBI will be calculated. VAS scores for the ability to delineate the lesion will be compared between WLE and NBI. Rate of inclusion of the biopsy point in the sweet spot on WLE and NBI will be compared.

Conditions

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Barrett Esophagus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Narrow band imaging (NBI)

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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Non-magnified white-light endoscopy (WLE)

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Reflux oesophagitis (Los Angeles grade ≥C);
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cambridge

OTHER

Sponsor Role lead

Responsible Party

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Massimiliano di Pietro, MD

Senior Clinician Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Massimiliano di Pietro, MD

Role: PRINCIPAL_INVESTIGATOR

MRC Cancer Unit.University of Cambridge.

Locations

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MRC Cancer Unit

Cambridge, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Massimiliano di Pietro, MD

Role: CONTACT

Phone: 01223763349

Email: [email protected]

Facility Contacts

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Massimiliano di Pietro, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 25209721 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27573768 (View on PubMed)

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.

Reference Type RESULT
PMID: 22315471 (View on PubMed)

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.

Reference Type RESULT
PMID: 14745410 (View on PubMed)

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.

Reference Type RESULT
PMID: 30419218 (View on PubMed)

Other Identifiers

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NiBOD

Identifier Type: -

Identifier Source: org_study_id