Surveillance vs. Endoscopic Therapy for Barrett's Esophagus With Low-grade Dysplasia
Key facts
- Who runs it
- University of Colorado, Denver
- Where
- Ann Arbor, Aurora, Baltimore, Birmingham, Boston, Camden, Chapel Hill, Charleston, Chicago, Cleveland, Dallas, Fort Wayne, Houston, Indianapolis, Jacksonville, Lebanon, Los Angeles, Manhasset, New York, Oakland, Philadelphia, Pittsburgh, Rochester, San Jose, Sarasota, Scottsdale, and St Louis, United StatesSee the 30 sites
- Trial code
- Status
- Recruiting
- People taking part
- 680 people, planned
- Started
- 24 Jan 2023
- Expected to end
- 30 Apr 2029
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Endoscopic Eradication Therapy
- Record updated
- 11 September 2026
Who can take part
- Age
- 18 years to 89 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- Meets all the following criteria will be eligible for enrollment:
- Male or female, age ≥18 years
- 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
- Biopsies within the previous 12 months demonstrating Barrett's esophagus and indeterminate for dysplasia or low grade dysplasia
- Confirmation of low grade dysplasia by expert central pathology panel from biopsies obtained within the previous 12 months
- Demonstrated ability to tolerate proton pump inhibitor (PPI) or potassium-competitive acid blocker (PCAB) 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
Who cannot take part
- Prior endoscopic eradication therapy for Barrett's esophagus
- 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
- History of high grade dysplasia or esophageal adenocarcinoma
- History of esophageal resection/esophagectomy
- Esophageal varices or known portal hypertension; and
- 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
- Pregnancy
- Active erosive esophagitis (Los Angeles Grade B or higher) - patients are eligible upon resolution of erosive esophagitis
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 89 years old?
Where in United States
- University of MichiganAnn Arbor, United StatesContact: Jaren FehlmanTaking people
- University of ColoradoAurora, United StatesContact: Sandra BoimboTaking people
- Johns Hopkins UniverstiyBaltimore, United StatesContact: Hilary CosbyTaking people
- University of Alabama at BirminghamBirmingham, United StatesContact: Shajan Peter, MDTaking people
- Beth Israel Deaconess Medical CenterBoston, United StatesContact: Douglas Pleskow, MDTaking people
- Cooper University HospitalCamden, United StatesContact: Anthony Infantolino, MDTaking people
- University of North Carolina School of MedicineChapel Hill, United StatesContact: Julia KimTaking people
- Medical University of South CarolinaCharleston, United StatesContact: Collins Ordiah, MDTaking people
- Northwestern Memorial HospitalChicago, United StatesContact: Justeena JojoTaking people
- Cleveland Clinic FoundationCleveland, United StatesContact: Vidhi PatelTaking people
- Cleveland VA Medical Research and Education FoundationCleveland, United StatesContact: Ashley Faulx, MDTaking people
- University Hospitals Cleveland Medical Center Case Western UniversityCleveland, United StatesContact: Wendy BrockTaking people
- Baylor University Medical CenterDallas, United StatesContact: Taryn KruseTaking people
- Parkview Research CenterFort Wayne, United StatesContact: Vanessa Case, MSNo longer taking part
- The University of Texas MD Anderson Cancer CenterHouston, United StatesContact: Raza BokhariTaking people
- Indiana University Melvin & Bren Simon Cancer CenterIndianapolis, United StatesContact: Mohammad Al-Hadded, MDTaking people
- Mayo ClinicJacksonville, United StatesContact: Swathi Eluri, MDTaking people
- Dartmouth Hitchcock Medical CenterLebanon, United StatesContact: Penny DoughtyTaking people
- University of California, Los AngelesLos Angeles, United StatesContact: Nazish ZafarTaking people
- Long Island Jewish Medical CenterManhasset, United StatesContact: Molly StewartTaking people
- Columbia UniverstiyNew York, United StatesContact: Kartharine D BoyceTaking people
- Kaiser Permanente Oakland Medical CenterOakland, United StatesContact: Gene K Ma, MDTaking people
- University of Pennsylania, Perelman School of MedicinePhiladelphia, United StatesContact: Christine Gepty, BSN, RNTaking people
- University of Pittsburgh Medical CenterPittsburgh, United StatesContact: Adalyn VincentTaking people
- Mayo ClinicRochester, United StatesContact: Cadman Leggett, MDTaking people
- University of Rochester Medical CenterRochester, United StatesContact: Chelsea DibellaTaking people
- Kaiser PermanenteSan Jose, United StatesContact: Victoria PeckhamTaking people
- Florida Digestive Health SpecialistsSarasota, United StatesContact: Vanessa Case, MSNo longer taking part
- Mayo ClinicScottsdale, United StatesContact: Prasad Iyer, MDTaking people
- Washington University in St. LouisSt Louis, United StatesContact: Thomas HollanderTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Endoscopic SurveillanceNo study treatment, for comparison
Subjects 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 TherapyTreatment being tested
Subjects 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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Multicenter Randomized Controlled Trial of Surveillance vs. Endoscopic Therapy for Barrett's Esophagus With Low-grade Dysplasia (The SURVENT Trial)
- Fit questions
- Built from NCT05753748, who can take part
- Record updated
- 11 September 2026