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

Launched by CLEVELAND VA MEDICAL RESEARCH AND EDUCATION FOUNDATION · Dec 17, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new way to screen for Barrett's esophagus (BE), a condition that can lead to esophageal cancer, in veterans who do not have chronic acid reflux. Traditionally, BE is diagnosed using a procedure called endoscopy, which can be expensive and isn't routinely recommended for screening. The study aims to test a simpler, non-endoscopic method, similar to a pap smear, which would make it easier and less costly to check for BE in outpatient settings. This will help identify more cases of BE early, especially in veterans who have increased risk factors such as obesity, tobacco use, and a family history of esophageal cancer.

To be eligible for this trial, participants need to be between 40 and 85 years old, have no history of chronic acid reflux symptoms, and meet specific criteria, including having at least three risk factors for BE. They should also be able to provide informed consent. If someone joins the study, they can expect to undergo the new screening procedure and may receive follow-up care based on the results. It's important to note that this trial is not yet recruiting participants, but it represents a significant step toward improving cancer screening for veterans at risk.

Gender

ALL

Eligibility criteria

• Inclusion 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:
• • a. Meet ACG/AGA Clinical Guideline criteria for BE screening. Eligible subjects will have at least three additional risk factors for BE (white race, obesity defined as BMI \> 30, male gender, current smoker or smoking history \> 10 pack years, family history of Barrett's esophagus or EAC central obesity (waist size \> 35 inches for women and \> 40 inches for men), white race, male sex, confirmed history of BE/EAC in at least two family members, with one a first degree relative).
• 3. No known coagulopathy, no known esophageal varices, not on chronic anticoagulation therapy, and have:
• • 4. No significant dysphagia or odynophagia
• Exclusion Criteria:
• • 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