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

Recruiting now · Not applicable

Conditions studied: Barretts Esophagus With Dysplasia, Barrett Esophagus, Esophageal Adenocarcinoma

In brief

The purpose of this study is to learn the best approach to treating patients with known or suspected Barrett's esophagus by comparing endoscopic surveillance to endoscopic eradication therapy. To diagnose and manage Barrett's esophagus and low-grade dysplasia, doctors commonly use procedures called endoscopic surveillance and endoscopic eradication therapy. Endoscopic surveillance is a type of procedure where a physician will run a tube with a light and a camera on the end of it down the patients throat and remove a small piece of tissue. The piece of tissue, called a biopsy, is about the size of the tip of a ball-point pen and is checked for abnormal cells and cancer cells. Endoscopic eradication therapy is a kind of surgery which is performed to destroy the precancerous cells at the bottom of the esophagus, so that healthy cells can grow in their place. It involves procedures to either remove precancerous tissue or burn it. These procedures can have side effects, so it is not certain whether risking those side effects is worth the benefit people get from the treatments. While both of these procedures are widely accepted approaches to managing the condition, there is not enough research to show if one is better than the other. Barrett's esophagus and low-grade dysplasia does not always worsen to high-grade dysplasia and/or cancer. In fact, it usually does not. So, if a patient's dysplasia is not worsening, doctors would rather not put patients at risk unnecessarily. On the other hand, endoscopic eradication therapy could possibly prevent the worsening of low-grade dysplasia into high-grade dysplasia or cancer (esophageal adenocarcinoma) in some patients. Researchers believe that the results of this study will help doctors choose the safest and most effective procedure for their patients with Barrett's esophagus and low-grade dysplasia. This is a multicenter study involving several academic, community and private hospitals around the United States. Up to 530 participants will be randomized. This study will also include a prospective observational cohort study of up to 150 Barrett's esophagus and low grade dysplasia patients who decline randomization in the randomized control trial but undergo endoscopic surveillance (Cohort 1) or endoscopic eradication therapy (Cohort 2), and are willing to provide longitudinal observational data.

Key facts

Study ID

NCT05753748

Run by

University of Colorado, Denver

People needed

680

Starts

2023-01-24

Expected to finish

2029-04-30

Last updated by the study team

2025-11-24

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Pregnancy;
• Prior endoscopic eradication therapy for Barrett's esophagus;
• History of high grade dysplasia or post-endoscopy esophageal adenocarcinoma;
• History of esophageal resection/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. * 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.

Where it is running

• University of California, Los Angeles — Los Angeles, California, United States (enrolling)
• Kaiser Permanente Oakland Medical Center — Oakland, California, United States (enrolling)
• Kaiser Permanente — San Jose, California, United States (enrolling)
• University of Colorado — Aurora, Colorado, United States (enrolling)
• Florida Digestive Health Specialists — Sarasota, Florida, United States (enrolling)
• Northwestern Memorial Hospital — Chicago, Illinois, United States (enrolling)
• Indiana University Melvin & Bren Simon Cancer Center — Indianapolis, Indiana, United States (enrolling)
• Johns Hopkins Universtiy — Baltimore, Maryland, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Washington University in St. Louis — St Louis, Missouri, United States (enrolling)
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)
• Long Island Jewish Medical Center — Manhasset, New York, United States (enrolling)
• Columbia Universtiy — New York, New York, United States (enrolling)
• University of Rochester Medical Center — Rochester, New York, United States (enrolling)
• University of North Carolina School of Medicine — Chapel Hill, North Carolina, United States (enrolling)
• University Hospitals Cleveland Medical Center Case Western University — Cleveland, Ohio, United States (enrolling)
• Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)
• University of Pennsylania, Perelman School of Medicine — Philadelphia, Pennsylvania, United States (enrolling)
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (enrolling)
• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
• Baylor University Medical Center — Dallas, Texas, United States (enrolling)
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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