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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
360
Robot assisted esophagectomy with extended two field lymphadenectomy.
Conventional thoracoscopic esophagectomy with extended two field lymphadenectomy.
General hospital of eastern theater command
Nanjing, Jiangsu, China
RECRUITINGThe First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
RECRUITINGChanghai Hospital, The Second Military Medical University
Shanghai, China
Overall Survival Rate
Time frame: 5 years
R0 resection (%)
Time frame: within 30 days after surgery
Overall Survival Rate
Time frame: 3 years
Disease Free Survival Rate
Time frame: 3 years
Postoperative major complications
Time frame: 30 days after surgery
In hospital mortality
For all patients, the cause of death will be noted. If applicable, the results of the autopsy report will be noted.
Time frame: 30-60 days after surgery
Operative duration
The operation time is defined as time from incision until closure (minutes) for both the thoracic phase and the abdominal phase of the procedure. For the robotic procedure, the set-up time will be recorded separately.
Time frame: during the operation, up to 5 hours
Postoperative recovery
Postoperative hospital stay, intensive care unit (ICU) stay
Time frame: from the date of surgery to the hospital discharge, assessed up to 15 days
Number of lymph nodes dissected
Time frame: within 30 days after surgery
Quality of life
The quality of life assessment was based on a previously validated questionnaire, QLQ-C30 (version 3.0; quality-of-life questionnaire), combined with an esophageal cancer-specific module, QLQ-OES18.
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Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, China
RECRUITINGShanghai Chest Hospital, Shanghai Jiao Tong University
Shanghai, China
RECRUITINGZhongshan Hospital, Fudan University
Shanghai, China
RECRUITINGTime frame: 2 years
Estimated blood loss
Time frame: during the operation, up to 5 hours
Disease Free Survival Rate
Time frame: 5 years