Robot-assisted Thoracic Approach Versus Open Transthoracic Esophagectomy .

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

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).

Rationale: Esophageal cancer represents the fifth most common tumor of cancers of the digestive system in Spain, between the ten most common cancers and the sixth leading cause of cancer death in the world. Among the standard modalities for treatment with curative intention, surgery is available, in combination with neoadjuvant (pre-surgery) and/or adjuvant (post-surgery) chemotherapy and radiation therapy. Esophageal surgery is crucial to improve overall survival in patients with esophageal cancer.

Surgical treatment is based on esophageal resection and reconstruction of digestive transit, as well as a correct lymphadenectomy. One of the techniques used is Ivor Lewis transthoracic esophagectomy. Classically, thoracic approach has been done by open approach (thoracotomy), with minimally invasive (laparoscopy) abdominal approach, a reality in our centre and in most European centres.

Postoperative comorbidity, specially respiratory complications, occur approximately in half of patients with esophagectomy with thoracotomy (open approach). Although current clinical trials have reported advantages over minimally invasive esophagectomy (MI), at the time, most esophageal surgery is performed by open approach. More studies are needed to clarify the role of minimally invasive esophagectomy in esophageal cancer, so as to provide evidence about the comorbidity and effectiveness of surgical robot-assisted technique.

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).

Objective: Evaluate the benefits, risks and cost-efficiency of Robot-assisted thoracic approach as a better approach to open transthoracic Ivor Lewis esophagectomy as treatment for esophageal cancer.

Study design: This is an investigator-initiated and investigator-driven monocentre randomized controlled parallel-group, phase IV, superiority trial.

Study populations: Patients (age ≥ 18) with histologically proven surgical resectable (cT1-4a, N0-3, M0) adenocarcinoma, squamous cell carcinoma, undifferentiated esophageal carcinoma or carcinomas of the esophagogastric junction (EGJ) (Siewert I or II) candidate to Ivor Lewis Esophagectomy.

Intervention:108 patients will be randomly allocated to either A) Robot-assisted thoracic approach or B) Open transthoracic esophagectomy, in Ivor Lewis technique. In both groups the abdominal approach will be performed by laparoscopy (minimally invasive).

Patients will receive the following interventions:

Group A. Robot-assisted thoracic approach in Ivor Lewis esophagectomy. Group B. Open transthoracic approach (thoracotomy) in Ivor Lewis esophagectomy.

Both surgical techniques are used in our usual clinical practice of the General and Digestive Surgery Department of the Bellvitge University Hospital (HUB).

Main study parameters/endpoints: Primary outcome is the percentage of respiratory and overall complications as stated by the modified Clavien-Dindo classification (MCDC).

Secondary outcomes are individual components of the primary endpoint (major and minor complications), (in hospital) mortality, R0 resections, oncologic outcomes, postoperative recovery, cost-effectiveness and quality of life.

Follow-up:84±3 days after hospital discharge.

NOTE: The project consists of a clinical trial and an extension study to assess the free-survival of 3 and 5 years from surgery.

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).