Comparing surveillance and therapy for Barrett's esophagus with low-grade dysplasia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to determine the most effective treatment approach for patients with Barrett's esophagus and low-grade dysplasia by comparing two methods: endoscopic surveillance and endoscopic eradication therapy. Patients will be randomly assigned to either receive regular surveillance endoscopies with biopsies or undergo procedures to eradicate precancerous cells. The study will monitor the outcomes over a maximum follow-up period of four years, assessing the effectiveness and safety of each approach. The goal is to provide clearer guidance on managing this condition to prevent progression to esophageal cancer.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Mayo Clinic
  Scottsdale, Arizona, United States Recruiting
• University of California, Los Angeles
  Los Angeles, California, United States Recruiting
• Kaiser Permanente Oakland Medical Center
  Oakland, California, United States Recruiting
• Kaiser Permanente
  San Jose, California, United States Recruiting
• University of Colorado
  Aurora, Colorado, United States Recruiting

Study contacts

• Principal investigator: Sachin Wani, MD — University of Colorado, Denver
• Study coordinator: Vanessa Case, MS
• Email: vanessa.case@cuanschutz.edu
• Phone: 303-724-5306

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Detecting Barrett's Esophagus in Patients Without GERD Symptoms

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• Assessing Barrett's Esophagus in Patients with Anorexia Nervosa and Purging Behaviors

  This study is trying to see if people with anorexia nervosa who purge have Barrett's esophagus, using non-invasive tests to check for this condition in patients aged 18-65.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.