The SURVENT Trial: A Multicenter Randomized Controlled Trial of Surveillance vs. Endoscopic Therapy for Barrett's Esophagus with Low-grade Dysplasia
Primary Objective: To compare the effectiveness of two approaches for the management of Barrett s esophagus (BE) and low-grade dysplasia (LGD), endoscopic surveillance and endoscopic eradication therapy (EET), using an accepted clinical endpoint of neoplastic progression [high-grade dysplasia (HGD)/mucosal esophageal adenocarcinoma (EAC)/invasive EAC]. Secondary Objectives: a. To compare patient-centered outcomes (PCOs), as defined and prioritized by key stakeholders (patients, caregivers, clinicians and others), in BE patients with LGD treated with EET to those undergoing surveillance. b. To determine the utility of select biomarkers, including a commercially-available biomarker panel (TissueCypher), histologic assessment by wide-area transepithelial sampling (WATS3D) with computer-assisted 3D analysis, and p53 immunohistochemistry (IHC) on forceps biopsies and on WATS3D samples, in risk stratification c. To establish a biorepository of specimens that include whole blood, serum, plasma, saliva, brushings and biopsy specimens from the esophagus (squamous and BE), gastric cardia and duodenum that will allow for future translational research including time course studies on mechanisms of disease progression and therapeutic response, identification of novel diagnostic markers, and novel therapeutic targets in this patient population. d. To compare progression rates to invasive EAC alone, complete eradication rates for both intestinal metaplasia (CE-IM) and dysplasia (CE-D), recurrence of intestinal metaplasia and dysplasia and adverse events between the two groups.
A Multicenter Randomized Controlled Trial of Surveillance vs. Endoscopic Therapy for Barrett's Esophagus with Low-grade DysplasiaMore
Diagnosis of Barrett's Esophagus and Low Grade Dysplasia.
Inclusion Criteria Any patient with BE and LGD 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 BE 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 BE and LGD; 4. Confirmation of LGD 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 PPI therapy based on patient self-report; and 6. Ability to discontinue antiplatelet and anticoagulant therapy based on standard guideline recommendations prior to and after endoscopic procedures.24 We will include non-English speaking patients based on the geographic locations of our sites and the single IRB of record will be responsible for the approval of certified-translated consents. 6.2 Exclusion Criteria* 1. Pregnancy; 2. Prior EET for BE; 3. History of HGD or EAC; 4. History of esophageal resection or 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. * 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.
Baylor Scott & White Health
Case Western Reserve University
Cleveland Clinic, Main
Geisinger Medical Center
Johns Hopkins/The Sidney Kimmel Cancer Center
Kaiser Permanente of Colorado
Mayo Clinic, Jacksonville
Mayo Clinic, Rochester
Medical University of South Carolina
Thomas Jefferson University Hospital Cancer Center
UCLA - University of California
University of Colorado Hospital
University of Michigan
University of North Carolina
University of Pennsylvania
Washington University, Siteman Cancer Center
Sachin Wani, MD
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