Esophageal Cancer Clinical Trial
Official title:
Robot-assisted Esophagectomy Versus Conventional Thoracoscopic Esophagectomy for Patients With Squamous Cell Esophageal Cancer: a Multicenter Open-label, Randomized Controlled Trial (RAMIE Trial)
This is the first randomized controlled study to compare the robot-assisted esophagectomy (RAE) to minimally invasive conventional thoracoscopic esophagectomy (CTE). The aim of this trial is to evaluate the safety, risks of the robot-assisted esophagectomy, and to compare the short-term operative outcomes and long-term oncological outcomes between the two surgical treatments.
Objective: This study aims to compare the oncological outcomes between robot-assisted
esophagectomy and minimally invasive conventional thoracoscopic esophagectomy.
Study design: Randomized controlled parallel-group superiority trial Study population:
Patients (age >= 18 and <= 75 years) with histologically proven surgically resectable
(cT1b-3, N0-2, M0) squamous cell carcinoma of the intrathoracic esophagus with European
Clinical Oncology Group performance status 0, 1 or 2.
Intervention: 360 patients will be randomly allocated to either A) robot-assisted
esophagectomy (n=180) or B) conventional thoracoscopic esophagectomy (n=180).
Patients will receive the following interventions:
Group A. robot assisted esophagectomy, with gastric conduit formation. Group B. conventional
thoracoscopic esophagectomy, with gastric conduit formation.
Main study parameters/endpoints: Primary outcome is 5-year overall survival rate.
Secondary outcomes are 5-year disease free survival, 3-year overall survival rate, 3-year
disease free survival, (in hospital) mortality within 30 and 60 days, R0 resections,
operation related events, postoperative recovery, lymph nodes status, quality of life.
Follow-up: 60 months after discharge of the last randomized patient.
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