non-small cell lung cancer
Conditions
Interventions
Systematic Lymph node Dissection
Selective Lymph node Dissection
Sponsors
Okayama University Thoracic Surgery Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: First stage registration 1)Contrast-enhanced CT, positron emission tomography-CT (or bone scintigraphy) and enhanced brain MRI findings fulfill all of the following conditions. i)resectable lung tumors. ii)no more than cT2a and without inter-lobe PL3. iii)no metastasis in mediastinal lymph nodes iv)non-small cell lung carcinoma is diagnosed or suspected. Neither Carcinoid nor large-cell neuroendocrine carcinoma. v)no distant metastasis. 2)Aged 75 or older. 3)No past history of ipsilateral thoracotomy. 4)No surgery, chemotherapy or radiation therapy for any malignant diseases in the past two years. 5)Lobectomy and systematic lymph node dissection are acceptable with following conditions. i) Predicted FEV1.0 <= 800mL ii) PaO2 >= 65 torr(room air) or SaO2 >= 94% (room air) 6)Performance Status(ECOG) is 0 or 1. 7)Hugh-Jones classification is I, II or III. 8)Checked about heart disease. 9)Checked about COPD. 10)Blood examinations fulfill following conditions i) WBC>=3,000 /mm3 ii) Hb>=8.0 g/dL iii) Plt>=10x104 /mm3 iv) AST<=100 U/L v) ALT<=100 U/L vi) T-bil<=2.0 mg/dL vii) Cre<=1.5 mg/dL 11) Written informed consent. Second stage registration Preoperative criteria 1)Sufficient organ functions. 2)Preoperative body temperature is 38C or less. Intraoperative criteria 1)The date of surgery (second registration) is within 42 days of the first registration. 2)Non-small cell lung carcinoma is diagnosed. Neither carcinoid nor large-cell neuroendocrine carcinoma. 3)Neither malignant pleural effusion nor pleural dissemination. 4)No inter-lobe PL3. 5)Pleural lavage cytology is not imperative and that result dose not affect the eligibility. 6)Completion of lobectomy and selective lymph node dissection. Metastasis is not diagnosed with frozen examination in the representative lymph nodes, including cN1, which are defined in the protocol. 7)No mediastinoscopy. 8)Latissimus dorsi and serratus anterior muscles are not cut completely. 9)Single lobectomy without angioplasty and bronchoplasty.
Exclusion criteria
Exclusion criteria: 1)Simultaneous or metachronous (within the past 2 years) double lung cancers. 2)Past history of #7 lymph node dissection for contralateral lung cancer resection. 3)Preoperative mediastinoscopy. 4)Interstitial pneumonitis. 5)Active bacterial or fungous infection. 6)Psychiatric disease. 7)Systemic steroids medication. 8)Uncontrollable diabetes mellitus. 9)Uncontrollable hypertension. 10)Past history of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months. 11)The attending doctor does not identify as eligible clinically.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of complications in the early postoperative period | — |
Countries
Japan
Contacts
Public ContactJunichi Soh
Okayama University Hospital Department of Thoracic Surgery
Outcome results
None listed