RecruitingNot ApplicableNCT04652180

Robot-assisted Thoracic Approach Versus Open Transthoracic Esophagectomy .

Clinical Trial Of Safety Of Robot-assisted Thoracic Approach Verus Open Transthoracic Esophagectomy in Esophageal Cancer.

Sponsor

Hospital Universitari de Bellvitge

Enrollment

108 participants

Start Date

Nov 6, 2020

Study Type

INTERVENTIONAL

Conditions

Esophageal Cancer Esophageal Carcinoma Postoperative Complications

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria3

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).

Interventions

PROCEDUREEsophagectomy

In this monocentre randomized controlled trial, we compare robot-assisted thoracic approach with conventional open transthoracic Ivor Lewis esophagectomy.