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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital Universitari de Bellvitge
RECRUITING
L'hospitalet De Llobregat
Contact Information
Primary
Natàlia Cornellà, Surgeon
nataliacornellagcirurgia@gmail.com
+34645976556
Time Frame
Start Date: 2020-11-06
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 108
Treatments
Experimental: Robot-assisted thoracic approach in Ivor Lewis esophagectomy
Robot-assisted thoracic approach in Ivor Lewis esophagectomy with gastric conduit formation. Abdominal approach will be performed by laparoscopy.
Active_comparator: Open transthoracic approach in Ivor Lewis esophagectomy
Traditional open transthoracic esophagectomy with gastric conduit formation. Abdominal approach will be performed by laparoscopy.
Related Therapeutic Areas
Sponsors
Collaborators: University of Barcelona
Leads: Hospital Universitari de Bellvitge

This content was sourced from clinicaltrials.gov