Esophagectomy: In this monocentre randomized controlled trial, we compare robot-assisted thoracic approach with conventional open transthoracic Ivor Lewis esophagectomy.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).
Primary outcome measure(s)
Respiratory postoperative complications. — Participants will be followed for the duration of hospital stay, an expected average of 2 weeks up to 84+/-3 days from hospital discharge. The primary outcome of this study is the percentage of respiratory complications as stated by the modified Clavien-Dindo classification of surgical complications (MCDC).
by means of AME chest approach by robot and thoracotomy (classic surgery).
Trial sites (1)
Facility
City
Region
Status
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat
Barcelona
Recruiting
More Hospital Universitari de Bellvitge trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
