Actively Recruiting
Robot-assisted Thoracic Approach Versus Open Transthoracic Esophagectomy .
Led by Hospital Universitari de Bellvitge · Updated on 2023-03-01
108
Participants Needed
1
Research Sites
320 weeks
Total Duration
On this page
Sponsors
H
Hospital Universitari de Bellvitge
Lead Sponsor
U
University of Barcelona
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Robot-assisted Thoracic Approach Versus Open Transthoracic Esophagectomy .
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed adenocarcinoma, squamous cell carcinoma, undifferentiated carcinoma, or carcinoma of the gastro-esophageal junction (Siewert I or II)
- Tumor is surgically resectable (T1-4a, N0-3, M0)
- For women of childbearing potential, a negative pregnancy test is required
- Signed informed consent provided
You will not qualify if you...
- Stage IV esophageal cancer or gastro-esophageal junction Siewert III cancer
- Contraindication for transthoracic esophagectomy involving two fields
- Presence of other cancers or conditions interfering with the study, such as prior thoracic surgery or trauma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907.
Actively Recruiting
Research Team
N
Natàlia Cornellà, Surgeon
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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