Esophageal cancer
Conditions
Interventions
Intervention Group:Robot-assisted esophagectomy
Control Group:Conventional minimally invasive thoraco-laparoscopic esophagectomy
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 20 to 80 years; 2. Karnofsky score above 80; 3. Histologically proven squamous cell carcinoma of the intrathoracic esophagus; 4. Primary tumor located in the thoracic esophagus. If the distance between the tumor center and the esophago-gastric junction is 1 year having passed since the last administration are eligible; 7. No prior lateral thoracotomy (or thoracoscopic surgery) on the right side or no prior lobectomy or more extended surgery on the left side has been performed; 8. Sufficient organ functions: (1) White blood cell (WBC) =3000/mm3; (2) Platelet =100000/mm3; (3) Hemoglobin =10 g/dl; (4) Total bilirubin <1.5 mg/dl; (5) Aspartate transaminase =100 IU/l; (6) Alanine aminotransferase =100 IU/l; (7) Creatinine =1.5 mg/dl; (8) SpO2 =95%; 9. R0 esophagectomy is expected; 10. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Carcinoma of the cervical esophagus; 2. Histologically proven adenocarcinoma or undifferentiated carcinoma; 3. Prior thoracic surgery at the right hemithorax or thoracic trauma; 4. Infectious disease with systemic therapy indicated; 5. Body temperature of 38 degree C or more; 6. Pregnancy, possible pregnancy, within 28 days after delivery or breast-feeding; 7. Severe psychiatric disease; 8. Continuous systemic steroid or immune-suppressive drug therapy; 9. Unstable angina pectoris or history of myocardial infarction within 6 months; 10. Severe pulmonary fibrosis or emphysema; 11. Poorly controlled hypertension; 12. Poorly controlled diabetes mellitus in spite of continuous use of insulin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year overall survival;; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year disease-free survival;R0 resection;operative duration;lymph node dissection;postoperative major complications;postoperative secondary complications;estimated blood loss; | — |
Countries
China
Contacts
Public ContactZhigang Li
Shanghai Chest Hospital
Outcome results
None listed