Nonendoscopic Screening for Barrett's Esophagus in Veterans Without Chronic Reflux
Recruiting · NCT06746623 · Interventional (participants receive a specific treatment) · Lead sponsor: Louis Stokes VA Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Patients without history of chronic GERD who meet criteria for upper endoscopic screening for BE will be accrued35.
- Adults \> 40 and \< 85 years old who have no prior EGD and can provide informed consent
- 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).
- No known coagulopathy, no known esophageal varices, not on chronic anticoagulation therapy, and have:
- No significant dysphagia or odynophagia
Exclusion criteria
- Exclusion Criteria
- History of prior EGD procedure in past ten years
- Inability to provide written informed consent
- History of weekly or more frequent heartburn or regurgitation for five or more years
- On anti-coagulant drug(s) that cannot be temporarily discontinued or coagulopathy with INR \> 1.5
- Known history of esophageal varices or esophageal stricture
- 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
- History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills
- Oropharyngeal tumor
- History of esophageal or gastric surgery, with exception on uncomplicated recent surgical fundoplication procedure with documented normal acid exposure time (AET) percent (AET \<4%)
- History of myocardial infarction or cerebrovascular accident within past 6 months
Where it is running
1 location listed across 1 US state.
- VA Northeast Ohio Healthcare System - Cleveland, Ohio, United States