Enhancing Screening Practices for BE

May 3, 2026 updated by: Arvind Trindade, MD, FACG, FASGE, Rutgers, The State University of New Jersey

Enhancing Screening Practices for Barrett's Esophagus

Previous studies have shown that screening for Barrett's esophagus (BE), the main risk factor for esophageal adenocarcinoma, is under-utilized in the primary care setting. In fact less than 35% of eligible patients are screened despite endorsement for screening by the major GI societies in patients with risk factors. The purpose of this study is to examine current screening practices and determine if implementation of screening reminders can optimize screening practices for Barrett's Esophagus within a large, academic based healthcare system in NJ.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Barrett's esophagus (BE) is a pre-malignant mucosal transformation of the distal esophageal mucosal lining whereby the metaplastic columnar epithelium replaces squamous epithelium of the esophagus. BE is the main risk factor to develop esophageal adenocarcinoma. The etiology of BE is complex and likely multifactorial, with several factors including gastrointestinal reflux (GERD), genetic factors, environmental triggers, immunoregulatory defects playing a role. It is well known that the transformation of cells lining the distal esophagus is due to chronic repeated insults by longstanding GERD.

A significant proportion of patients diagnosed with BE are discovered during endoscopic evaluation of middle-aged and older adults however a majority of cases are unrecognized. The vast majority of patients (up to 90%) with EAC have never had a diagnosis of BE. A major limitation of BE screening are those individuals with silent or asymptomatic GERD. In a study evaluating the sensitivity of guidelines by determining the proportion of prevalent EAC that met screening criteria for BE by American College of Gastroenterology (ACG) or the British Society of Gastroenterology (BSG) guidelines, 54.9% of the US patients and 38.9% of the UK patients would not have been identified by current screening guidelines. Furthermore, the reason most patients (US, 86.5%; UK, 61.4%) did not meet screening guidelines was the lack of symptomatic GERD.

Currently, upper endoscopy with biopsies remains the gold standard for the diagnosis of BE however there is a significant need for other, non-invasive screening tools that are easy to implement, cost-friendly, and patient friendly. Other options include trans-nasal endoscopy and non-endoscopic cell collection devices which can be used in the outpatient setting and avoids need for sedation. Trans-nasal endoscopy remains costly, operator-dependent, and uncomfortable or distressing to patients. Current non-endoscopic cell collection devices include Cytosponge (Medtronic GI Solutions), EsoCheck (Lucid Diagnostics), and EsophaCap (Capnostics) which have demonstrated excellent safety, tolerability, and sensitivity for the diagnosis of BE. Nonendoscopic devices are currently an approved method of screening per the 2022 American College of Gastroenterology (ACG) society guidelines on diagnosis of BE.

The presence of metabolic disease increases the risk of developing cancer. Early studies suggested the presence of metabolic syndrome and visceral fat (eg, MASLD, pancreatic fatty infiltration) are associated with BE and typically portray higher risk for progression to dysplasia or neoplasia. Current standard is EGD for screening of BE and surveillance determined by histology and length of mucosal changes. The role of evaluation for visceral adiposity, either via cross-sectional imaging or endoscopic ultrasound, has not been elucidated. Factoring visceral adiposity may allow the investigators to risk-stratify patients for screening or optimize surveillance strategies to prevent progression to EAC.

This is a single center randomized controlled trial examining whether implementation of screening reminders for eligible patients will increase BE screening rates. The investigators will enroll 8 practices (see below) in the New Brunswick area. 4 practices will be randomized to the screening reminder arm and 4 practices will be randomized to the no reminder screening arm. In each arm baseline data will be collected on BE screening rates for the practice prior to the study for comparison.

The screening reminder arm will undergo the following. Patient's medical charts will be screened via epic to determine if patients meet criteria for BE screening per the ACG (American College of Gastroenterology) or ASGE (American Society of GI Endoscopy) guidelines. Charts will be screened by a gastroenterology fellow on the study team or a gastroenterology attending on the study team. If patients qualify for screening, the provider will receive an email and Epic chat the day before the patient's office appointment with the provider letting them know which patients on their panel qualify for screening for BE.

Providers in both arms of the study will be notified of GI services to help screen patients for BE prior the study inception, including referral to GI clinic for nonendoscopic screening.

BE screening is part of standard of care for patients who meet criteria, as defined by ACG/ASGE guidelines. Sending reminders to primary care offices/staff is not standard of care. The 8 practices are affiliated with RWJ Barnabas Health Medical group. Reminders (email or Epic chat) will be sent the day before the patient's scheduled appointment with the provider. Data regarding demographics, comorbidities, and presence of other factors that qualify patients into BE screening will be recorded. The investigators will then record which patients were or were not screened for BE with either invasive (eg, EGD) or non-invasive measures.

Study Type

Interventional

Enrollment (Estimated)

3000

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Robert Wood Johnson Medical School
        • Principal Investigator:
          • Arvind Trindade, MD
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years of age or older
  • Have a scheduled appointment with a participating provider

Exclusion Criteria:

  • Less than 18 years of age

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

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention
Other: Screening Reminder
A reminder to screen this patient for Barrett's esophagus (BE) will be sent to the provider before the patient's scheduled appointment. The reminder will provide details about which criteria this patient meets in order to indicate that BE screening should be initiated.
No Intervention: Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BE screening rate
Time Frame: 1 year
Percentage increase in BE screening compared to each arm's historical control BE screening rate from the year prior.
1 year

Collaborators and Investigators

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

Sponsor

Rutgers, The State University of New Jersey

Investigators

  • Principal Investigator: Arvind Trindade, MD, Professor of Medicine

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 (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

May 3, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro2025000949

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported, following deidentification. Data will only be shared upon request, for an approved proposal, after review and approval by Rutgers University.

IPD Sharing Time Frame

Beginning 3 months and ending 5 years following publication.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal, following approval by Rutgers University.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

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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