Non-small cell lung cancer
Conditions
Interventions
Experimental group:Lob or segmentectomy + lobar-specific mediastinal lymph node dissection
Control group:Lob or segmentectomy + systemic mediastinal lymph node dissection group
Sponsors
Cancer Hospital, Chinese Academy of Medical Science
Eligibility
Sex/Gender
All
Age
20 Years to 70 Years
Inclusion criteria
Inclusion criteria: Initial inclusion criteria: (1) 20-70 years old; (2) chest CT showed a single pulmonary nodule; (3) chest CT showed multiple pulmonary nodules, but preoperative evaluation of pulmonary nodules other than the main lesion should be considered Benign or no tumor-specific treatment within 5 years; (4) chest CT is considered non-small cell lung cancer, the largest diameter of the lung window: d=30mm, 0.25<CTR=1 (CTR: consolidation tumor ratio); (5) Preoperative adjuvant The examination showed no lymph node metastasis, no distant metastasis, clinical stage I (UICC-TNM 8th edition); (6) ECOG score 0-1; (7) Preoperative pulmonary function FEV1=1.0L and actual value/expected (8) Preoperative electrocardiogram: normal; (9) Technically, anatomic lobectomy or segmentectomy + lymph node dissection can be performed. Secondary inclusion criteria: (1) The time between operation and chest CT, pulmonary function, and electrocardiogram examinations is less than or equal to 30 days; (2) The operation is completed totally by thoracoscopy; (3) Intraoperative frozen pathology confirmed non-small cell lung cancer (neuroendocrine). (4) Intraoperative determination of lobectomy or segmentectomy + systemic/lobar-specific lymph node dissection is feasible.
Exclusion criteria
Exclusion criteria: Initial exclusion criteria: (1) Chest CT prompts and considers multiple primary lung cancers and is expected to require multiple treatments within 5 years; (2) History of thoracic and mediastinal surgery; (3) History of neoadjuvant therapy; (4) History of previous malignant tumors; (5) ) Pregnant/lactating women; (6) History of myocardial infarction, cerebral infarction, pneumonia 6 months before surgery; (7) Complicated with active bacterial or fungal infection; (8) Complicated with interstitial lung disease, pulmonary fibrosis or severe Pulmonary underlying diseases such as emphysema, or a history of pulmonary tuberculosis; (9) Combined with mental illness; (10) Combined with uncontrolled hypertension, diabetes and other serious underlying diseases; (11) Preoperative examination of patients with significantly abnormal coagulation function (12) Suspected metastatic lesions or suspected primary malignant tumors combined with other sites were found in preoperative staging examination. Secondary exclusion criteria: (1) Surgical treatment was not completed as scheduled; (2) Lob or segmentectomy was not performed due to intraoperative freezing, the patients intraoperative condition was not allowed, etc.; (3)After intraoperative exploration, the extent of resection is more than one lobe due to the condition (such as compound lobectomy, pneumonectomy, lobectomy + wedge resection, segmentectomy + wedge resection, lobectomy + segmentectomy,etc) (4) Intraoperative conversion to thoracotomy; (5) Intraoperative exploration found that the The characteristics of non-localized lung cancer such as gross lymph node involvement, local tumor invasion, pleural dissemination, pleural effusion, etc.; (6) In patients who underwent intraoperative lobe-specific lymph node dissection, frozen pathology indicated that the dissected largest hilar and mediastinal lymph nodes had metastasis (7) Intraoperative pulmonary nodule frozen pathological return of benign lesions or non-primary non-small cell lung cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year recurrence rate after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complication rate within 30 days after surgery;The incidence of various complications;operation time;Intraoperative blood loss;postoperative drainage time;postoperative hospital stay;30-day postoperative mortality;DFS;OS; | — |
Countries
China
Contacts
Public ContactZhao Jun
Cancer Hospital, Chinese Academy of Medical Science
Outcome results
None listed