Comparing Surveillance to Endoscopic Therapy for Barrett's Esophagus with Low-Grade Dysplasia

This study is comparing two ways to manage Barrett's esophagus with low-grade dysplasia (abnormal cells in the esophagus that could become cancer). You would either receive endoscopic surveillance, which involves regular checks with a scope and biopsies (small tissue samples), or endoscopic eradication therapy. Endoscopic eradication therapy is a procedure that uses a scope to remove or burn away the abnormal cells. The goal is to see which approach is better at preventing the abnormal cells from getting worse. This study is looking for 680 participants between 18 and 89 years old who have Barrett's esophagus with low-grade dysplasia. The study's current status is unclear.

Study design
This is an interventional study that will randomly assign participants to either endoscopic eradication therapy or endoscopic surveillance. It plans to enroll 680 participants.
What's involved
If you have newly diagnosed low-grade dysplasia, you would have surveillance endoscopies every 6 months for the first year, then annually. If you have had low-grade dysplasia for over a year, you would have annual endoscopies. If you receive endoscopic eradication therapy, you would have treatments every 2-3 months until the abnormal cells are gone or you've had 5 treatments.
Compensation
Not stated in the trial record.
Follow-up
The maximum follow-up period for participants is 4 years, with neoplastic progression (the abnormal cells getting worse) measured from baseline through study completion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05753748

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

Recruiting
NAAges 18–89InterventionalTreatment
University of Colorado, Denver
~680 participants
Updated 2025-11-24 on ClinicalTrials.gov
What's tested:Endoscopic Eradication Therapy

At a glance

Recruiting sites
23 of 23 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Neoplastic Progression
Measured over Baseline, through study completion
Barretts Esophagus With Dysplasia
Barrett Esophagus
Esophageal Adenocarcinoma
23 sites across 16 states
California3
New York3
Ohio2
Pennsylvania2
Texas2
Colorado1
Florida1
Illinois1
  • Sachin Wani, MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver
  • Nicholas J Shaheen, MD, MPH · PRINCIPAL_INVESTIGATOR · University of North Carolina
  • Valerie Durkalski, MPH, PhD · PRINCIPAL_INVESTIGATOR · Medical University of South Carolina
  • Rhonda Souza, MD · PRINCIPAL_INVESTIGATOR · Baylor University

Opens a ready-to-send draft in your own email app — review before sending.

  • Neoplastic ProgressionBaseline, through study completion

    The occurrence of high grade dysplasia/mucosal post-endoscopy esophageal adenocarcinoma/invasive post-endoscopy esophageal adenocarcinoma at any time during the study period following enrollment.