Impact of NBI on Patients Undergoing Endoscopic Eradication Therapy

November 1, 2019 updated by: Sri Komanduri, Northwestern University

A Multicenter Study Evaluating the Impact of NBI on Patients With Barrett's Esophagus Associated Neoplasia Undergoing Endoscopic Eradication Therapy (EET)

This study tests the impact of narrow band imaging (NBI) on endoscopists' accurate detection of visible lesions and dysplasia in patients with Barrett's esophagus, as well as the effect of NBI on the choice of primary treatment modality among endoscopists performing endoscopic eradication therapy (EET).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Barrett's esophagus (BE), is a condition whereby normal esophageal squamous epithelium is replaced by metaplastic columnar epithelium, predisposing patients to esophageal adenocarcinoma (EAC). It is estimated that about 5.6% of adults in the United States have BE with risk factors including: long standing gastroesophageal reflux disease, tobacco use, male gender, central obesity, and age over 50 years. EAC is believed to progress in a step-wise pattern with the following order of non-dysplastic BE, low-grade dysplasia (LGD), and high-grade dysplasia (HGD). Each carries a risk of progression to EAC, differing by degree of dysplasia: 0.2-0.5%, 0.7%, and 7% per year, respectively. Given this association, it is common practice to perform endoscopic surveillance with biopsies in patients with BE. Endoscopic surveillance has been shown to detect EAC at earlier stages and improve survival in asymptomatic presentations. As dysplasia in BE may not always be seen as a distinct lesion, surveillance programs entail use of the Seattle Protocol, a systematic four-quadrant biopsy technique obtained at 1 to 2 cm increments. Current guidelines recommend the use of high-definition white light endoscopy (HD-WLE) as it is superior over standard-definition in regards to improved targeted detection of dysplasia.

Advanced endoscopic imaging techniques have been proposed to improve dysplasia detection with preference for electronic chromoendoscopy, specifically narrow band imaging (NBI), as it does not require dye sprays. NBI has been shown to be more accurate in detecting intestinal metaplasia and HGD. HGD is more often detected in areas with subtle mucosal and vascular abnormalities, which may be more difficult to see on HD-WLE alone. However, subtle lesions may go undetected, as NBI is not routinely used in the community with a recent survey showing only about a third of practicing gastroenterologists use advanced endoscopic imaging. The widespread use of NBI has been potentially limited by a perceived complexity of interpretation and lack of standardization. Recently, Sharma et al introduced the BING criteria - a standardized classification system to detect dysplasia and EAC with NBI. While a few studies have demonstrated no significant difference in detection of dysplasia or neoplasia between HD-WLE and NBI, they have had some limitations. The studies occurred prior to the BING classification system, and participants were limited to a few expert tertiary medical centers.

The current standard of care for visible lesions identified by HD-WLE (nodules, ulcers, erosions, or plaques) is endoscopic mucosal resection (EMR). Endoscopic recognition and appropriate resection of visible lesions is essential for optimal patient outcomes. Staging EMR is critical as it allows for histopathological "upgrading" or "downgrading" of dysplasia and ultimately is the best tool for identifying and treating early EAC. Despite the importance of EMR for BE-AN, survey data suggests it is underutilized in practice with 39% of academic endoscopists and 13% of community-based endoscopists performing EMR. While many endoscopists utilize NBI to assist in identification of visible lesions, the resection of areas deemed "abnormal" by NBI alone is not widely accepted. Moreover, endoscopists at community hospitals detect neoplastic lesions at significantly lower rates than at BE expert centers.

Given these data, routine use of NBI prior to EET could significantly impact treatment decisions among all endoscopists with highly accurate rates of dysplasia detection. It's been shown that NBI increases the accuracy and positive predictive value of predicting histology than if HD-WLE is used alone. This study is limited by the use of still-images, which does not accurately reproduce live images seen during endoscopy. Nevertheless, the current standard of using HD-WLE for identification of visible lesions likely underestimates the presence of dysplastic areas in patients undergoing Endoscopic Eradication Therapy (EET) for BE-AN. We hypothesize that the routine use of narrow band imaging (NBI) for identification of visible lesions will improve dysplasia detection and have a significant effect on the choice of primary treatment modality among endoscopists performing EET. To this end, we propose a video-based study to evaluate the impact of NBI on choice of treatment modality during EET.

Study Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Endoscopist sub-groups include academic endoscopists performing greater than 50 EET procedures per year, community endoscopists performing greater than 50 EET procedures per year, 25 academic gastroenterologists performing greater than 500 upper endoscopies per year not including EET, and 25 community gastroenterologists performing greater than 500 upper endoscopies per year not including EET.

Description

Inclusion Criteria:

  • Endoscopists familiar with EET.

Exclusion Criteria:

  • Endoscopists not familiar with EET or non-endoscopists.
  • Special populations will not be included in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Endoscopists familiar with EET
Physicians familiar with conducting endoscopic eradication therapy.
Other: Video intervention
Video clips of endoscopy footage with just HD-WLE and clips with NBI will be shown to endoscopists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Altered chosen treatment modality due to NBI
Time Frame: 1 year
Percentage of cases in which use of NBI altered decision-making in regards to initial treatment modality for patients undergoing EET.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% visable dysplastic lesions detected
Time Frame: 1 year
Percentage of visible dysplastic lesions detected by HD-WLE and NBI across all participants stratified by subgroup of experience
1 year
Accurate pathology assessment
Time Frame: 1 year
Accuracy of pathology assessment by endoscopists using HD-WLE and NBI in patients undergoing EMR
1 year
Differences in pathology identification between subgroups
Time Frame: 1 year
Differences in identification of pathology based on subgroup of experience, volume of EET, and type of practice.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

May 10, 2019

Study Completion (Actual)

May 10, 2019

Study Registration Dates

First Submitted

June 15, 2017

First Submitted That Met QC Criteria

June 15, 2017

First Posted (Actual)

June 19, 2017

Study Record Updates

Last Update Posted (Actual)

November 4, 2019

Last Update Submitted That Met QC Criteria

November 1, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00205021

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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