NCT04652180 Robot-assisted Thoracic Approach Versus Open Transthoracic Esophagectomy .
| NCT ID | NCT04652180 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Universitari de Bellvitge |
| Condition | Esophageal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2020-11-06 |
| Primary Completion | 2025-12-30 |
Trial Parameters
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Brief Summary
This is a randomized controlled trial designed to compare robot-assisted thoracic approach with open transthoracic esophagectomy (Ivor Lewis technique) as a surgical treatment for resectable esophageal cancer. If our hypothesis is proved correct, robot-assisted thoracic approach will result in a lower percentage of respiratory and overall postoperative complications, lower blood loss, shorter hospital stay, but with at least similar oncologic outcomes and better postoperative quality of life compared with the open transthoracic esophagectomy (current standard).
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years. * Histologically proven adenocarcinoma, squamous cell carcinoma, undifferentiated carcinoma or carcinoma of the gastro-esophageal junction (GEJ) Siewert I or II. * Surgical resectable (T1-4a, N0-3, M0). * Childbearing potential women (period between menarche and menopause), pregnancy negative test is mandatory. * Written informed consent. Exclusion Criteria: * Stage IV or GEJ Siewert III esophageal cancer. * Contraindication of transthoracic esophagectomy in two fields. * Pre- or concomitant cancer or conditions which interferes with the study (e.g. prior thoracic surgery or trauma. Rationale: these patients may undergo open resection).
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