Ensayos clínicos

Inclusion Criteria:

• Any patient with Barrett's Esophagus (BE) and  Low-grade Dysplasia (LGD) who provides informed consent AND meets all the following criteria will be eligible for enrollment.
• Male or female, age ≥ 18 years.
• Subject has endoscopic evidence of BE characterized by the presence of salmon-colored mucosa in the tubular esophagus of at least 1 cm in length as well as endoscopic biopsies from the involved areas demonstrating columnar metaplasia with goblet cells. This inclusion criterion will exclude patients with intestinal metaplasia with dysplasia of the gastric cardia.
• Biopsies within the previous 12 months demonstrating BE and LGD.
• Confirmation of LGD by expert central pathology panel from biopsies obtained within the previous 12 months (including those obtained from the referring physician).
• Demonstrated ability to tolerate PPI therapy based on patient self-report; and;
  • Ability to discontinue antiplatelet and anticoagulant therapy based on standard guideline recommendations prior to and after endoscopic procedures.24.
• We will include non-English speaking patients based on the geographic locations of our sites and the single IRB of record will be responsible for the approval of certified-translated consents.

*Exclusion Criteria:

• Pregnancy.
• Prior EET for BE.
• History of HGD or EAC.
• History of esophageal resection or esophagectomy.
• Active erosive esophagitis (Los Angeles Grade B or higher) - patients are eligible upon resolution of erosive esophagitis.
• Esophageal strictures precluding passage of the endoscope or treatment catheters – patients are eligible upon resolution of esophageal stricture due to endoscopic dilation or resolution with medical therapy.
• Esophageal varices or known portal hypertension; and;
  • Life expectancy of < 2 years as judged by the site investigator.

*  Patients are eligible for enrollment and randomization if they meet the above eligibility criteria. It should be noted that the presence of a visible lesion (nodularity) at the index endoscopy is not an exclusion criterion.  Those with visible lesions will undergo endoscopic mucosal resection (EMR) to determine pathology. If HGD or EAC pathology is determined, then the subject will exit from the study after a 30-day safety follow up.

Eligibility last updated 7/18/22. Questions regarding updates should be directed to the study team contact.