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Nonendoscopic Screening for Barrett's Esophagus in Veterans Without Chronic Reflux

Description

The veteran population is at increased risk for EAC and its precursor lesion, Barrett's esophagus (BE), due to increased prevalence of disease risk factors compared to the general population. BE is traditionally diagnosed only when patients undergo endoscopy with biopsies. However, due to the high cost of endoscopy and the lack of studies proving efficacy of screening, endoscopy to screen for BE is not routinely recommended. A simpler screening procedure similar to a pap smear would be an ideal way to sample the esophageal tissue for cancer and its precursor condition, BE. This study proposes a non-endoscopic detection method administered in outpatient offices which would increase subsequent endoscopic detection of BE. The study team will be enrolling veterans who do not have history of gastroesophageal reflux but have multiple risk factors for esophageal adenocarcinoma.

Conditions

Obese PatientsTobacco UseVeteransFamily History of Esophageal CancerBarrett Esophagus
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Related Conditions:

Obese PatientsTobacco UseVeteransFamily History of Esophageal CancerBarrett Esophagus

Study Overview

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Study Details

Study overview

The veteran population is at increased risk for EAC and its precursor lesion, Barrett's esophagus (BE), due to increased prevalence of disease risk factors compared to the general population. BE is traditionally diagnosed only when patients undergo endoscopy with biopsies. However, due to the high cost of endoscopy and the lack of studies proving efficacy of screening, endoscopy to screen for BE is not routinely recommended. A simpler screening procedure similar to a pap smear would be an ideal way to sample the esophageal tissue for cancer and its precursor condition, BE. This study proposes a non-endoscopic detection method administered in outpatient offices which would increase subsequent endoscopic detection of BE. The study team will be enrolling veterans who do not have history of gastroesophageal reflux but have multiple risk factors for esophageal adenocarcinoma.

Nonendoscopic Screening for Barrett's Esophagus and Esophageal Cancer in At-Risk Veterans Without History of Chronic Gastroesophageal Reflux

Nonendoscopic Screening for Barrett's Esophagus in Veterans Without Chronic Reflux

Condition
Obese Patients
Intervention / Treatment

-

Contacts and Locations

Cleveland

VA Northeast Ohio Healthcare System, Cleveland, Ohio, United States, 44106

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patients without history of chronic GERD who meet criteria for upper endoscopic screening for BE will be accrued35.
  • 1. Adults \> 40 and \< 85 years old who have no prior EGD and can provide informed consent
  • 2. Absence of chronic GERD symptoms (absence of weekly heartburn or regurgitation, not on medications for GERD), and are:
  • 3. No known coagulopathy, no known esophageal varices, not on chronic anticoagulation therapy, and have:
  • 4. No significant dysphagia or odynophagia
  • * Exclusion Criteria
  • 1. History of prior EGD procedure in past ten years
  • 2. Inability to provide written informed consent
  • 3. History of weekly or more frequent heartburn or regurgitation for five or more years
  • 4. On anti-coagulant drug(s) that cannot be temporarily discontinued or coagulopathy with INR \> 1.5
  • 5. Known history of esophageal varices or esophageal stricture
  • 6. Any contraindication, as deemed in Investigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGD procedure, and/or having biopsies taken, including but not limited to due to comorbidities such as coagulopathy or a known history of esophageal diverticula, esophageal fistula and/or esophageal ulceration
  • 7. History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills
  • 8. Oropharyngeal tumor
  • 9. History of esophageal or gastric surgery, with exception on uncomplicated recent surgical fundoplication procedure with documented normal acid exposure time (AET) percent (AET \<4%)
  • 10. History of myocardial infarction or cerebrovascular accident within past 6 months

Ages Eligible for Study

40 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cleveland VA Medical Research and Education Foundation,

Katarina B Greer, MD/MS, PRINCIPAL_INVESTIGATOR, Cleveland VA Research and Education Foundation

Study Record Dates

2028-12-31