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Modular Robot-Assisted Versus Conventional Minimally Invasive Esophagectomy for Esophageal Cancer
Sponsor: Ruijin Hospital
Summary
This study evaluates the safety, efficacy, and health economic outcomes of modular robotic-assisted minimally invasive esophagectomy (RAMIE) compared with conventional thoracoscopic minimally invasive esophagectomy (MIE) in patients with resectable esophageal cancer. Participants are randomly assigned in a 1:1 ratio to undergo either modular robotic-assisted esophagectomy using the Carina™ Surgical Platform (experimental group) or conventional thoracoscopic esophagectomy (control group). The primary endpoint is the rate of Textbook Outcome (TO) within 30 days post-operation. Secondary endpoints include operative parameters, quality of life, overall survival, disease-free survival, and health economic metrics.
Official title: A Prospective, Multicenter, Randomized Controlled Trial Comparing Modular Robot-Assisted Esophagectomy Versus Conventional Thoracoscopic Esophagectomy for Esophageal Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2026-10-15
Completion Date
2031-10-30
Last Updated
2026-10-22
Healthy Volunteers
No
Conditions
Interventions
Modular Robot-Assisted Esophagectomy
Robot-assisted minimally invasive esophagectomy performed using the Carina™ modular surgical platform for radical resection of resectable esophageal cancer. The procedure will be performed by trained surgeons using the Carina™ system and compatible surgical instruments.
Conventional Minimally Invasive Esophagectomy
Conventional minimally invasive esophagectomy performed using standard thoracoscopic and laparoscopic surgical techniques for radical resection of resectable esophageal cancer. Commercially available conventional endoscopic surgical equipment, including 3-dimensional thoracoscopic systems routinely used at participating centers, may be used.
Locations (1)
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China