esophageal cancer
Conditions
Interventions
robotic esophagectomy with lymphadenectomy
Sponsors
National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Staging of tumor is performed according to the UICC/AJCC 7th edition of the TNM Classification of Malignant Tumours. To be eligible for this study, patients must fulfill all of the following criteria: 1) Histologically proven squamous cell carcinoma, adenosquamous carcinoma or basaloid cell carcinoma. 2) Primary tumor located in thoracic esophagus. Tumor which is centrally located more than 2 cm below of the esophago-gastric junction is ineligible 3) Either single lesion or multiple lesions. Second tumors in cervical esophagus which is indicated for EMR/ESD are also eligible. 4) Clinical stages I, II or III (excluding T4b) based on the 7th UICC-TNM classification. 5) Aged 20 to 80 years. 6) No prior lateral thoracotomy (or thoracoscopic surgery) on right side or no prior lobectomy or more extended surgery on left side was performed. 7) No prior treatment against esophageal cancer except for i)-iii) i) Non-curative resection for primary tumor by EMR/ESD. ii) Clinical stage IB, II or III esophageal cancer patients who received 2 courses or less of cisplatin plus fluorouracil. iii) Curative resection had been achieved by EMR/ESD against metachronous multiple cancer. 8) No prior treatment of chemotherapy or radiation therapy against any other malignancies. History of adjuvant hormonal therapy after more than 1 year from the last administration is eligible. 9) No prior gastrectomy. 10) Sufficient organ functions. i. WBC >= 3,000/mm3 ii. Platelet >= 100,000/mm3 iii. Hemoglobin >=10mgldL iv. AST =< 100 IU/L , ALT =< 100 IU/L v. T.Bil =< 2.0 mg/dL vi. Creatinine =< 1.5 mg/dL 11) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy. 2) Pregnancy or breast-feeding. 3) Severe psychiatric disease. 4) Continuous systemic steroid or immune-suppressive drug therapy. 5) Unstable angina pectoris, or history of myocardial infarction within six months 6) Poorly controlled hypertension. 7) Poorly controlled diabetes mellitus in spite of continuous use of insulin. 8) BMI of 30 or more. 9) Other reasons of not to perform robotic esophagectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the achievement rate of robotic esophagectomy | — |
Secondary
| Measure | Time frame |
|---|---|
| the incidence of postoperative laryngeal nerve palsy and other complications | — |
Countries
Japan
Contacts
Public ContactJun Kanamori
National Cancer Center Hospital Division of Esophageal Surgery
Outcome results
None listed