Clinical Trial

EMR Versus ESD for Barrett's Neoplasia

Study acronym: REMOVE-RCT
Recruiting
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Summary
Rationale: The optimal technique for removal of visible dysplastic lesions in Barrett's esophagus remains controversial. Endoscopic mucosal resection (EMR) is safe, effective, easy to apply, and has been the most widely used technique since 2008. Endoscopic submucosal dissection (ESD) is a more controlled dissection method with potential improved efficacy, but at the cost of higher technical complexity. Objective: The investigators aim to compare EMR and ESD for removal of visible lesions in Barrett's esophagus. Study design: Randomized clinical trial Study population: Patients with Barrett's esophagus and a visible lesion with dysplasia and/or early cancer. Suspicion for submucosal invasion is an exclusion criterion. Intervention: Patients are randomized to receive either EMR or ESD, with follow-up and no ablation during 12 months after the resection. Main study endpoint: Primary endpoint is the proportion of patients with no evidence of residual or local recurrent neoplasia during 12 months follow-up after baseline.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2022-03-09; most recent amendment 2026-06-24.
Status change: Not Yet Recruiting → Recruiting 2026-06-24
Trial Details
NCT Number NCT05276791
Lead Sponsor St. Antonius Hospital
Collaborators: University Medical Center Groningen, Erasmus Medical Center, UMC Utrecht, Amsterdam University Medical Center, Catharina Ziekenhuis Eindhoven
Conditions Barretts Esophagus With Dysplasia, Barrett Adenocarcinoma, Esophageal Cancer
Enrollment 331 participants
Start Date 2023-01-17
Primary Completion 2027-12-01 (estimated)
Study Completion 2028-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-29