Robot-assisted Thoracic Approach Versus Open Transthoracic Esophagectomy .
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Universitari de Bellvitge
About this trial
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
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Esophagectomy
Treatment groups
108 Participants
are divided into 2 treatment groupsLocations
1Hospital Universitari de Bellvitge08907., L'Hospitalet de LlobregatBarcelona, Spain
Sponsors and collaborators
Hospital Universitari de Bellvitge
Lead sponsor
University of Barcelona
Collaborator
Source ClinicalTrials.gov