A Multicenter Randomized Controlled Trial of Surveillance vs. Endoscopic Therapy for Barrett's Esophagus With Low-grade Dysplasia (The SURVENT Trial)
Mohammad Al-Haddad, MD
Primary Investigator
Brief description of study
What is the purpose of this study?
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. 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.
Detailed description of study
What will happen during the study?
Patients with Barrett's esophagus and low grade dysplasia will be recruited in the multicenter trial. Patients will be randomized into endoscopic eradication therapy or 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 with a maximum follow up period of 4years.
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.
Subjects will be contacted 48-72 hours and 30 days post procedure. All subjects will also receive follow-up phone calls on a semi-annual basis by a blinded central study coordinator.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Barrett Esophagus, Barretts Esophagus With Dysplasia, Esophageal Adenocarcinoma
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Age: 18 years or above
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Gender: All
Inclusion criteria
- 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 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.
Exclusion Criteria:
- 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
- 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.
