Surveillance vs. Endoscopic Therapy for Barrett's Esophagus With Low-grade Dysplasia

Launched by UNIVERSITY OF COLORADO, DENVER · Feb 22, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the best way to treat patients with Barrett's esophagus, a condition where the cells lining the esophagus change and can potentially lead to cancer. The study compares two approaches: endoscopic surveillance, which involves taking small samples of tissue to check for abnormal cells, and endoscopic eradication therapy, a procedure that aims to remove or destroy these precancerous cells. Researchers want to determine if one method is more effective or safer than the other, particularly since Barrett's esophagus with low-grade dysplasia does not always progress to more serious conditions.

To participate in this trial, you must be at least 18 years old and have been diagnosed with Barrett's esophagus and low-grade dysplasia based on recent biopsies. The trial is open to both men and women, and you’ll need to be able to tolerate certain medications. If you join, you will be randomly assigned to one of the treatment groups or, if you prefer, you can participate in a separate observational study where you choose your treatment. Throughout the trial, you will be closely monitored to track your health and the outcomes of the treatments. This research aims to help doctors make better decisions for patients facing this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria: Any patient with Barrett's esophagus and low grade dysplasia who provides informed consent AND:
• Meets all the following criteria will be eligible for enrollment:
• • 1. Male or female, age ≥18 years,
• • 2. Subject has endoscopic evidence of Barrett's esophagus 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,
• • 3. Biopsies within the previous 12 months demonstrating Barrett's esophagus and low grade dysplasia,
• • 4. Confirmation of low grade dysplasia by expert central pathology panel from biopsies obtained within the previous 12 months (including those obtained from the referring physician),
• • 5. Demonstrated ability to tolerate proton pump inhibitor (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.
• Exclusion Criteria:
• • 1. Pregnancy;
• • 2. Prior endoscopic eradication therapy for Barrett's esophagus;
• • 3. History of high grade dysplasia or post-endoscopy esophageal adenocarcinoma;
• • 4. History of esophageal resection/esophagectomy
• • 5. Active erosive esophagitis (Los Angeles Grade B or higher) - patients are eligible upon resolution of erosive esophagitis;
• • 6. 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;
• • 7. Esophageal varices or known portal hypertension; and
• • 8. Life expectancy of \<2 years as judged by the site investigator. \* Presence of a visible lesion (nodularity) at the index endoscopy is not an exclusion criterion. Subjects with visible lesions will undergo endoscopic mucosal resection (EMR) to determine pathology; those with high grade dysplasia or post-endoscopy esophageal adenocarcinoma pathology will exit the study after a 30-day safety follow up.