Endoscopic Therapy vs Surveillance for Barrett's Esophagus

(SURVENT Trial)

Recruiting in Palo Alto (17 mi)

+22 other locations

Overseen by Valerie Durkalski, MPH, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Colorado, Denver

Must be taking: Proton pump inhibitors

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Pregnancy, Prior eradication therapy, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires participants to stop taking antiplatelet and anticoagulant medications before and after endoscopic procedures, based on standard guidelines. It does not specify other medications, so you may not need to stop taking them.

What data supports the effectiveness of the treatment Endoscopic Eradication Therapy for Barrett's Esophagus?

Research shows that Endoscopic Eradication Therapy (EET) is effective in treating Barrett's Esophagus by achieving complete eradication of abnormal cells, which can help prevent the progression to cancer. Studies indicate that EET is the standard care for Barrett's Esophagus-related neoplasia, with an average of three sessions needed to achieve complete eradication.

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Is endoscopic eradication therapy (EET) safe for humans?

Several studies have shown that endoscopic eradication therapy (EET) is generally safe for treating Barrett's esophagus, a condition that can lead to esophageal cancer. The therapy is widely used and recommended by medical societies for managing this condition.

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How is endoscopic eradication therapy different from other treatments for Barrett's esophagus?

Endoscopic eradication therapy (EET) is unique because it directly targets and removes abnormal cells in the esophagus using an endoscope (a flexible tube with a camera and tools), aiming to completely eradicate the precancerous condition known as Barrett's esophagus. Unlike other treatments that may focus on managing symptoms or preventing acid reflux, EET actively removes the problematic tissue, reducing the risk of progression to cancer.

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Eligibility Criteria

This trial is for adults over 18 with Barrett's esophagus and low-grade dysplasia, who can tolerate acid-reducing medication and stop blood thinners before endoscopic procedures. It excludes those with high-grade dysplasia or cancer, active severe esophagitis, short life expectancy, pregnancy, prior surgery or treatment on the esophagus, and certain esophageal conditions.

Inclusion Criteria

I have Barrett's esophagus with low grade dysplasia and agree to participate.

I am 18 years old or older.

My biopsy from the last year shows Barrett's esophagus with low grade dysplasia.

Exclusion Criteria

Life expectancy of <2 years as judged by the site investigator

I have had surgery to remove part or all of my esophagus.

Pregnancy

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either endoscopic eradication therapy or endoscopic surveillance based on randomization

3.5 years

Every 2-3 months for eradication therapy; every 6 months for surveillance

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Semi-annual follow-up calls

Long-term Follow-up

Continued monitoring of participants for progression to high-grade dysplasia or cancer

Until study completion

Participant Groups

The study compares two methods for managing Barrett's esophagus: 'endoscopic surveillance' (monitoring through a camera-tube down the throat) versus 'endoscopic eradication therapy' (surgery to remove or destroy precancerous cells). Up to 530 participants will be randomly assigned to either method in various U.S. hospitals.

Group I: Endoscopic Eradication Therapy Experimental Treatment 1 Intervention

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.

Group II: Endoscopic Surveillance Active Control 1 Intervention

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 Therapy is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Endoscopic Eradication Therapy for:

• Barrett's esophagus with dysplasia
• Early neoplasia

🇺🇸 Approved in United States as Endoscopic Eradication Therapy for:

• Barrett's esophagus with dysplasia
• Early esophageal adenocarcinoma

🇨🇦 Approved in Canada as Endoscopic Eradication Therapy for:

• Barrett's esophagus with dysplasia
• Early neoplasia

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of California, Los Angeles Los Angeles, CA

Kaiser Permanente Oakland Medical Center Oakland, CA

Kaiser Permanente San Jose, CA

Florida Digestive Health Specialists Sarasota, FL

More Trial Locations

Who Is Running the Clinical Trial?

University of Colorado, Denver Lead Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Collaborator

Baylor University Collaborator

University of North Carolina Collaborator

Medical University of South Carolina Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

Endoscopic eradication therapy for Barrett's oesophagus: state of the art. [2022] Barrett's oesophagus is the only identifiable precursor lesion to oesophageal adenocarcinoma. The stepwise progression of Barrett's oesophagus to dysplasia and invasive carcinoma provides the opportunity to intervene and reduce the morbidity and mortality associated with this lethal cancer. Several studies have demonstrated the efficacy and safety of endoscopic eradication therapy (EET) for the management of Barrett's oesophagus related neoplasia. The primary goal of EET is to achieve complete eradication of intestinal metaplasia (CE-IM) followed by enrolment of patients in surveillance protocols to detect recurrence of Barrett's oesophagus and Barrett's oesophagus related neoplasia.

2. United States pubmed.ncbi.nlm.nih.gov

Incidence of Esophageal Adenocarcinoma, Mortality, and Esophagectomy in Barrett's Esophagus Patients Undergoing Endoscopic Eradication Therapy. [2023] Endoscopic eradication therapy (EET) is the preferred treatment for Barrett's esophagus (BE)-related neoplasia patients. However, the impact of EET on critical outcomes, outside of clinical trials and registry data, remains scarcely studied. We aimed to assess real-world practice patterns and clinical outcomes among BE patients undergoing EET.

3. Germany pubmed.ncbi.nlm.nih.gov

Threshold evaluation for optimal number of endoscopic treatment sessions to achieve complete eradication of Barrett's metaplasia. [2022] Endoscopic eradication therapy (EET) is the standard of care for Barrett's esophagus (BE)-associated neoplasia. Previous data suggest the mean number of EET sessions required to achieve complete eradication of intestinal metaplasia (CE-IM) is 3. This study aimed to define the threshold of EET sessions required to achieve CE-IM.

4. United States pubmed.ncbi.nlm.nih.gov

Management of Post Ablative Barrett's Esophagus: a Review of Current Practices and Look at Emerging Technologies. [2023] Endoscopic eradication therapy is an effective and durable treatment for Barrett's esophagus (BE) related neoplasia, but even after achieving successful eradication, these patients remain at risk for recurrence and require ongoing routine examinations. The optimal surveillance protocol including endoscopic technique, sampling strategy, and timing are still being refined. The aim of this review is to discuss current management principles for the post ablation patient and emerging technologies to guide clinical practice.

5. United States pubmed.ncbi.nlm.nih.gov

Endoscopic eradication therapy for mucosal neoplasia in Barrett's esophagus. [2018] Endoscopic eradication therapy is frequently used to treat dysplasia and early cancers in Barrett's esophagus. This review addresses some of the recent developments in the field of endoscopic eradication therapy for Barrett's esophagus.

6. England pubmed.ncbi.nlm.nih.gov

A cost-effectiveness analysis of endoscopic eradication therapy for management of dysplasia arising in patients with Barrett's oesophagus in the United Kingdom. [2020] Endoscopic eradication therapy (EET) is the first line approach for treating Barrett's oesophagus (BE) related neoplasia globally. The British Society of Gastroenterology (BSG) recommend EET with combined endoscopic resection (ER) for visible dysplasia followed by endoscopic ablation in patients with both low and high grade dysplasia (LGD and HGD). The aim of this study is to perform a cost-effectiveness analysis for EET for treatment of all grades of dysplasia in BE patients.

7. United States pubmed.ncbi.nlm.nih.gov

Persistent intestinal metaplasia after endoscopic eradication therapy of neoplastic Barrett's esophagus increases the risk of dysplasia recurrence: meta-analysis. [2019] Endoscopic eradication therapy (EET) is the main treatment for dysplastic Barrett's esophagus and intramucosal adenocarcinoma. Although the goal of EET is to achieve complete remission of intestinal metaplasia (CRIM), treatment might achieve complete remission of dysplasia (CR-D) only, without achieving CRIM. Persistent intestinal metaplasia after eradication of dysplasia might carry a higher risk for progression into advanced neoplasia.