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EMR Versus ESD for Barrett's Neoplasia

Study acronym: REMOVE-RCT
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) to St. Antonius Hospitalv3 Show 6 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Dec 1, 2025 to Dec 1, 2027
    • Study completion date: Dec 1, 2026 to Dec 1, 2028
    • Start date changed from estimate of Dec 1, 2022 to Jan 17, 2023
    • Eligibility criteria expanded, about 68 words
    • Collaborators: 6 to 5
  2. Start date: Apr 1, 2022 to Dec 1, 2022v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)		 Barretts Esophagus With Dysplasia, Barrett Adenocarcinoma, Esophageal Cancer
Related terms Barrett Esophagus, Esophageal Neoplasms
Enrollment 331 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov