Esophageal Cancer, Esophageal Carcinoma
Conditions
Keywords
robot assisted esophagectomy, minimally invasive esophagectomy, esophageal cancer
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREesophagectomy
Robot assisted esophagectomy with extended two field lymphadenectomy.
Sponsors
Ruijin Hospital
Changhai Hospital
Shanghai Zhongshan Hospital
The First Affiliated Hospital of Nanchang University
Shanghai Chest Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically proven squamous cell carcinoma of the intrathoracic esophagus. * Surgical resectable (T1b-3, N0-2, M0) * Age ≥ 18 and ≤ 75 years * European Clinical Oncology Group performance status 0, 1 or 2 * Written informed consent
Exclusion criteria
* Carcinoma of the cervical esophagus * Histologically proven adenocarcinoma or undifferentiated carcinoma. * Prior thoracic surgery at the right hemithorax or thorax trauma. * Infectious disease with systemic therapy indicated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival Rate | 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival Rate | 3 years | — |
| Disease Free Survival Rate | 3 years | — |
| Postoperative major complications | 30 days after surgery | — |
| In hospital mortality | 30-60 days after surgery | For all patients, the cause of death will be noted. If applicable, the results of the autopsy report will be noted. |
| R0 resection (%) | within 30 days after surgery | — |
| Postoperative recovery | from the date of surgery to the hospital discharge, assessed up to 15 days | Postoperative hospital stay, intensive care unit (ICU) stay |
| Number of lymph nodes dissected | within 30 days after surgery | — |
| Quality of life | 2 years | 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. |
| Estimated blood loss | during the operation, up to 5 hours | — |
| Operative duration | during the operation, up to 5 hours | 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. |
Countries
China
Contacts
Primary ContactZhigang Li, Master
Backup ContactXiaobin Zhang, Doctor
Outcome results
None listed