Recruiting

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

Sponsor:

University of Colorado, Denver

Code:

NCT05753748

Conditions

Barretts Esophagus With Dysplasia

Barrett Esophagus

Esophageal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Endoscopic Eradication Therapy

Study Details

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.

Conditions

Barretts Esophagus With Dysplasia

Barrett Esophagus

Esophageal Adenocarcinoma

Study ID

NCT05753748

Start date

Jan 24, 2023

Status verified date

Aug, 2026

Completion date

Apr 30, 2029

Anticipated

Primary completion date

Apr 30, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

680 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Endoscopic Surveillance

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.

experimental: Endoscopic Eradication Therapy

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.

Interventions

Endoscopic Eradication Therapy

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.

Primary outcome measure

Neoplastic Progression [ Time Frame: Baseline, through study completion ]

Central Contacts and Locations

Central contacts

Vanessa Case, MS

303-724-5306 vanessa.case@cuanschutz.edu

Sandra Boimbo

303-724-8892 sandra.boimbo@cuanschutz.edu

Locations

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Nazish Zafar

310-206-6710 nzafar@mednet.ucla.edu

Principal Investigator:

V. Raman Muthusamy, MD

Kaiser Permanente Oakland Medical Center

Recruiting

Oakland, California, United States, 94611

Contacts

Gene K Ma, MD

408-972-6530 gene.k.ma@kp.org

Kaiser Permanente

Recruiting

San Jose, California, United States, 95119

Contacts

Victoria Peckham

408-972-6530 victoria.k.peckham@kp.org

Principal Investigator:

Gene Ma, MD

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Sandra Boimbo

3037248892 sandra.boimbo@cuanschutz.edu

Florida Digestive Health Specialists

Recruiting

Sarasota, Florida, United States, 34239

Contacts

Jennifer Faircloth

941-952-1145 jfaircloth@suncoastendoscopy.com

Principal Investigator:

F. Scott Corbett, MD, FASGE

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Justeena Jojo

312-695-5620 justeena.jojo@northwestern.edu

Principal Investigator:

Srinadh Komanduri, MD

Indiana University Melvin & Bren Simon Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Mohammad Al-Hadded, MD

317-278-9242 moalhadd@iu.edu

Johns Hopkins Universtiy

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Hilary Cosby

410-502-2893 hcosby1@jhmi.edu

Principal Investigator:

Macia Canto, MD

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Douglas Pleskow, MD

617-632-8623 dpleskow@bidmc.harvard.edu

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Jaren Fehlman

734-845-5865 jfehlman@med.umich.edu

Principal Investigator:

Joel Rubenstein, MD

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Thomas Hollander

314-747-1973 hollanderT@wustl.edu

Principal Investigator:

Vladimir Kushnir, MD

Dartmouth-Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Penny Doughty

603-695-2840 penny.j.doughty@hitchcock.org

Diane Rivera

000-000-0000 diane.rivera@va.gov

Principal Investigator:

Heiko Pohl, MD

Long Island Jewish Medical Center

Recruiting

Manhasset, New York, United States, 11030

Contacts

Molly Stewart

718-470-4667 mstewart8@northwell.edu

Principal Investigator:

Arvind Trindade, MD, FASGE

Columbia Universtiy

Recruiting

New York, New York, United States, 10032

Contacts

Kartharine D Boyce

212-305-9542 KB3217@cumc.columbia.edu

Rowena Fang

212-305-9541 RF2808@cumc.columbia.edu

Principal Investigator:

Julian Abrams, MD

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

Chelsea Dibella

(585)-275-0803 Chelsea_dibella@urmc.rochester.edu

Principal Investigator:

Vivek Kaul, MD

University of North Carolina School of Medicine

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Julia Kim

919-843-3946 Julia_Kim@med.unc.edu

Principal Investigator:

Nicholas Shaheen, MD, MPH

University Hospitals Cleveland Medical Center Case Western University

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Wendy Brock

206-844-3853 wendy.brock@uhhospitals.org

Principal Investigator:

Amitabh Chak, MD

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Vidhi Patel

216-363-5555 pdatelv18@ccf.org

Kevin Kruszewski

216-636-5555 kruszek@ccf.org

Principal Investigator:

Prashanthi Thota, MD

University of Pennsylania, Perelman School of Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Christine Gepty, BSN, RN

215-349-8556 christine.gepty@pennmedicine.upenn.edu

Principal Investigator:

Gary Falk, MD, MS

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Adalyn Vincent

AMV116@pitt.edu

Principal Investigator:

Kevin Mcgrath

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Collins Ordiah, MD

943-876-1648 ordiah@cusc.edu

Principal Investigator:

B Joseph Elmunzer, MD

Baylor University Medical Center

Recruiting

Dallas, Texas, United States, 75246

Contacts

Taryn Kruse

469-800-7050 taryn.kruse@bswhealth.org

Daniel S Kim

469-800-7050 daniel.kim3@bswhealth.org

Principal Investigator:

Vani Konda, MD

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Raza Bokhari

rhbokhari@mdanderson.org

Principal Investigator:

Mehnaz Shafi

More Information

Sponsor

University of Colorado, Denver

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Keywords

Barrett Esophagus
Esophageal Adenocarcinoma
Dysplasia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-09-02.