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โ† Trials
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EMR Versus ESD for Barrett's Neoplasia

RecruitingNAAges 18 Years - anyAllSt. Antonius Hospital
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In plain words

What the trial is, and whether it could suit you

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: Pri

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Patients age: โ‰ฅ 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 Exclusion Criteria: * Patients with visible lesions with suspicion of submucosal invasion based on assessment of the adjudication committee * Patients with HGD in at least one random biopsy, before inclusion (i.e. during endoscopy in the referring center \<3 months before imaging, or during imaging endoscopy) * History of esophageal surgery other than fundoplication * History of esophageal ablation therapy * In case of prior endoscopic resection, the target lesion located within 1 cm of the prior resection site * Uncontrolled coagulopathy with INR \>2.0, thrombocytopenia with platelet counts \< 50,000 * Esophageal varix or varices * Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines * Life expectancy \<2 years
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What it tests

  • EMR
  • ESD
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Where

6 sites
Amsterdam University Medical Center
Amsterdam, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
University Medical Center Groningen
Groningen, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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