Endoscopic Mucosal Resection Versus Endoscopic subMucosal Dissection fOr Removal of Visible Lesions in Barrett's Esophagus With Early Neoplasia: a Randomized Controlled Trial
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.
• Patients age: ≥ 18 years
• Willingness to undergo both EMR or ESD
• Ability to provide written, informed consent (approved by IRB) and understand the responsibilities of trial participation
• BE with at least one visible lesion (target lesion) with absence of signs of submucosal invasion on endoscopy, after evaluation by the adjudication committee
• Multiple lesions are allowed as long as the lesions are considered eligible for endoscopic treatment. Only the target lesion is evaluated for the study
• Prior endoscopic resection is allowed