Robot-assisted Thoracic Approach Versus Open Transthoracic Esophagectomy .
Recruiting now · Not applicable
Conditions studied: Esophageal Cancer, Esophageal Carcinoma, Postoperative Complications
In brief
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).
Key facts
- Study ID
- NCT04652180
- Run by
- Hospital Universitari de Bellvitge
- People needed
- 108
- Starts
- 2020-11-06
- Expected to finish
- 2026-12-30
- Last updated by the study team
- 2023-03-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat, Barcelona, Spain (enrolling)
Full record on ClinicalTrials.gov
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