Endoscopic Therapy vs Surveillance for Barrett's Esophagus (SURVENT Trial)

N/A

Recruiting

Led By Sachin Wani, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, through study completion

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two approaches to treating Barrett's esophagus and low-grade dysplasia to learn which is best.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Endoscopic eradication therapy may cause complications like pain, bleeding, infection or narrowing of the esophagus. The risks must be weighed against potential benefits such as preventing progression from low-grade dysplasia to cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, through study completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, through study completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, through study completion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Neoplastic Progression

Secondary study objectives

Biomarker Utility

Esophogeal Adenocarcinoma (EAC) progression rate

Patient-Reported Depression, Anxiety, and Gastrointestinal Symptoms

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Endoscopic Eradication TherapyExperimental Treatment1 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 SurveillanceActive Control1 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.

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