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RAMIE Versus MIE for Resectable Esophageal Cancer, a Randomized Controlled Trial (ROBOT-2 Trial).

RecruitingNAAges 18 Years - 90 YearsAllUniversity Medical Center Mainz
NCT04306458 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

BACKGROUND: For patients with esophageal cancer, radical esophagectomy with 2-field lymphadenectomy is the cornerstone of the multimodality treatment with curative intent. Both, conventional minimally invasive esophagectomy (MIE) and robot assisted minimally invasive esophagectomy (RAMIE) were shown to be superior compared to open transthoracic esophagectomy considering postoperative complications. However, no randomized comparison was made until now to compare MIE to RAMIE OBJECTIVES: The objective is to evaluate the extent of lymph node dissection, efficacy, risks, quality of life and cost-effectiveness of RAMIE as an alternative to MIE as treatment for esophageal adenocarcinoma or adenocarcinoma of the gastroesophageal junction.. METHODS: This is an investigator-initiated and investigator-driven multicenter randomized controlled parallel-group, superiority trial. All adult patients

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📋 Eligibility rules (as published)
Inclusion Criteria: * Histologically proven adenocarcinoma of the intrathoracic esophagus and gastroesophageal junction (including Siewert I and II) * Surgically resectable (T1-4a, N0-3, M0) * Age ≥ 18 and ≤ 90 years * European Clinical Oncology Group (ECOG) performance status 0,1 or 2 * Written informed consent Exclusion Criteria: * Esophageal squamous cell carcinoma * Carcinoma of the cervical esophagus * Carcinoma of the gastro-esophageal junction (GEJ) with the main part of the tumor in the gastric cardia (Siewert type III) * Prior thoracic surgery at the right hemithorax or thoracic trauma
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What it tests

  • Minimally invasive esophagectomy
  • daVinci Xi system
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Where

1 site
University Medical Center Mainz
Mainz, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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