An official website of the United States government
Endoscopic Surveillance versus Endoscopic Eradication Therapy for the Management of Barrett Esophagus and Low-Grade Dysplasia, SURVENT Trial
Trial Status: active
This clinical trial compares the effect of endoscopic eradication therapy (EET) to endoscopic surveillance with biopsies for the treatment and management of Barrett's esophagus with low-grade dysplasia. Barrett’s esophagus is a common condition in which the esophagus (swallowing tube) becomes damaged by acid reflux. Barrett’s esophagus can lead to dysplasia, or precancerous change in the esophagus. In a small proportion of people, this can lead to cancer of the esophagus, known as esophageal adenocarcinoma. Low-grade dysplasia is when cells are slightly abnormal, high-grade dysplasia is when cells are very abnormal. Catching dysplasia early is very important to prevent cancer. Endoscopic surveillance is where an endoscope (tube with a light and a camera on the end of it) is put down the throat so that a small piece of tissue can be removed from the esophagus. Tissue samples during endoscopy are collected in two different ways, through brushings and biopsy. Tissue brushings are when a specially designed brush takes cells from a layer of tissue. A biopsy removes tissue with a fine needle to be examined by a pathologist to determine the extent of a disease. The piece of tissue is about the size of the tip of a ball-point pen and is checked for abnormal cells and cancer cells. EET is a procedure 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 are performed through the endoscope. This study is designed to examine if EET is better or worse than endoscopic surveillance at managing Barrett's esophagus.
Inclusion Criteria
Male or female, age >= 18 years
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
Biopsies within the previous 12 months demonstrating BE and LGD
Confirmation of LGD 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
Ability to discontinue antiplatelet and anticoagulant therapy based on standard guideline recommendations prior to and after endoscopic procedures
We will include non-English speaking patients based on the geographic locations of our sites and the single institutional review board (IRB) of record will be responsible for the approval of certified-translated consents
Exclusion Criteria
Pregnancy
Prior EET for BE
History of HGD or EAC
History of esophageal resection or 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
Life expectancy of < 2 years as judged by the site investigator
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05753748.
I. 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:
I. 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.
II. 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 three-dimensional (3D) analysis, and p53 immunohistochemistry (IHC) on forceps biopsies and on WATS3D samples, in risk stratification.
III. 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.
IV. 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.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo surveillance endoscopy at baseline and every 12 months, and undergo blood sample and saliva collection prior to, and endoscopic biopsies and esophageal brushings during each endoscopic procedure on study. Patients whose tissue has gotten worse (high grade dysplasia) or turned into cancer are offered EET.
ARM II: Patients undergo endoscopy and treatment with EET every 2-3 months for a maximum of 5 times on study. Patients also undergo blood sample and saliva collection prior to, and endoscopic biopsies and esophageal brushings during each endoscopic procedure on study.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUCHealth University of Colorado Hospital
