RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: University of Colorado, Denver • ClinicalTrials.gov ID: NCT05753748

Registry updated: 2026-09-11

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Endoscopic Eradication Therapy (Procedure)
Endoscopic eradication therapy is a procedure performed to destroy the precancerous cells at the bottom of your esophagus, so that healthy cells can grow in their place. It involves procedures to either remove precancerous tissue or burn it. These procedures are performed through the endoscope.

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 indeterminate for dysplasia or low grade dysplasia; 4. Confirmation of low grade dysplasia by expert central pathology panel from biopsies obtained within the previous 12 months; 5. Demonstrated ability to tolerate proton pump inhibitor (PPI) or potassium-competitive acid blocker (PCAB) therapy based on patient self-report; and, 6. 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 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. \* 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

Conditions

Barretts Esophagus With Dysplasia Barrett Esophagus Esophageal Adenocarcinoma

Locations

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

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment