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

A Multicenter Randomized Controlled Trial of Surveillance vs. Endoscopic Therapy for Barrett's Esophagus With Low-grade Dysplasia (The SURVENT Trial)

Not applicable Interventional University of Colorado, Denver · NCT05753748

This study is testing whether regular check-ups or a treatment to remove precancerous cells is better for people with Barrett's esophagus and low-grade dysplasia.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment680 (estimated)
Ages18 Years to 89 Years
SexAll
SponsorUniversity of Colorado, Denver Academic / other
Locations23 sites (Los Angeles, California and 22 other locations)
Trial IDNCT05753748 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with Barrett's esophagus and confirmed low-grade dysplasia.

Not a fit: Patients with Barrett's esophagus but without low-grade dysplasia or those with other esophageal conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies that reduce the risk of esophageal cancer in patients with Barrett's esophagus.

How similar studies have performed: Other studies have shown promising results with endoscopic eradication therapy for Barrett's esophagus, suggesting this approach may be effective.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Los Angeles, California and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Barretts Esophagus With DysplasiaBarrett EsophagusEsophageal AdenocarcinomaDysplasia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.