Surveillance vs. Endoscopic Therapy for Barrett's Esophagus With Low-grade Dysplasia
SURVENT
A Multicenter Randomized Controlled Trial of Surveillance vs. Endoscopic Therapy for Barrett's Esophagus With Low-grade Dysplasia (The SURVENT Trial)
3 other identifiers
interventional
680
1 country
23
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2023
Longer than P75 for not_applicable
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2023
CompletedStudy Start
First participant enrolled
January 24, 2023
CompletedFirst Posted
Study publicly available on registry
March 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2029
November 24, 2025
November 1, 2025
6.3 years
January 23, 2023
November 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neoplastic Progression
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.
Baseline, through study completion
Secondary Outcomes (5)
Work Productivity and Activity
Baseline, through study completion
Biomarker Utility
Baseline, through study completion
Esophageal Adenocarcinoma (EAC) progression rate
Baseline, through study completion
Patient-Reported Depression, Anxiety, and Gastrointestinal Symptoms
Baseline, through study completion
Patient-Reported Gastroesophageal Reflux
Baseline, through study completion
Study Arms (2)
Endoscopic Surveillance
NO INTERVENTIONSubjects in the randomized control trial and observational cohort study, undergoing surveillance endoscopy will undergo surveillance biopsies in a 4-quadrant fashion every 1 cm throughout the extent of the Barrett's esophagus using the Seattle biopsy protocol, along with targeted biopsies from any visible lesions. For incident low grade dysplasia (newly diagnosed low grade dysplasia - within 12 months of enrollment), surveillance endoscopies will be performed every 6 months for the first year and then annually until the end of the study period. For prevalent low grade dysplasia (diagnosed \>1 year prior to enrollment), surveillance endoscopies will be performed annually until the end of the study period. The number of evaluations will depend on a subject's enrollment time.
Endoscopic Eradication Therapy
EXPERIMENTALSubjects undergoing endoscopic eradication therapy will undergo radiofrequency ablation every 2-3 months until complete eradication of intestinal metaplasia (CE-IM) is achieved or 5 treatments have been delivered, whichever is first. After achieving CE-IM, surveillance endoscopy will performed every 6 months for the first year and annually thereafter until the end of the study period. Surveillance biopsies will be obtained using a standardized protocol.
Interventions
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
You may qualify if:
- Meets all the following criteria will be eligible for enrollment:
- Male or female, age ≥18 years,
- Biopsies within the previous 12 months demonstrating Barrett's esophagus and low grade dysplasia,
- 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),
- 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.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- Baylor Universitycollaborator
- University of North Carolinacollaborator
- Medical University of South Carolinacollaborator
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)collaborator
Study Sites (23)
University of California, Los Angeles
Los Angeles, California, 90095, United States
Kaiser Permanente Oakland Medical Center
Oakland, California, 94611, United States
Kaiser Permanente
San Jose, California, 95119, United States
University of Colorado
Aurora, Colorado, 80045, United States
Florida Digestive Health Specialists
Sarasota, Florida, 34239, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Johns Hopkins Universtiy
Baltimore, Maryland, 21205, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Washington University in St. Louis
St Louis, Missouri, 63110, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Long Island Jewish Medical Center
Manhasset, New York, 11030, United States
Columbia Universtiy
New York, New York, 10032, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
University of North Carolina School of Medicine
Chapel Hill, North Carolina, 27599, United States
University Hospitals Cleveland Medical Center Case Western University
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
University of Pennsylania, Perelman School of Medicine
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sachin Wani, MD
University of Colorado, Denver
- PRINCIPAL INVESTIGATOR
Nicholas J Shaheen, MD, MPH
University of North Carolina
- PRINCIPAL INVESTIGATOR
Valerie Durkalski, MPH, PhD
Medical University of South Carolina
- PRINCIPAL INVESTIGATOR
Rhonda Souza, MD
Baylor University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2023
First Posted
March 3, 2023
Study Start
January 24, 2023
Primary Completion (Estimated)
April 30, 2029
Study Completion (Estimated)
April 30, 2029
Last Updated
November 24, 2025
Record last verified: 2025-11