Comparison of cVATS Segmentectomy Versus Lobectomy for Lung Adenocarcinoma in Situ and With Microinvasion

This is a Prospective, open-label, parallel, multi-center, Phase III randomized trial to evaluate the efficacy and safety of video-assisted thoracoscopic segmentectomy versus Lobectomy in treating patients with Lung adenocarcinoma in situ or with microinvasion.

Sex

All

Minimum age

20 Years

Maximum age

79 Years

Inclusion Criteria:

Preoperative criteria: peripheral non-small cell lung cancer, no larger than 2 cm in maximal diameter, no lymph node metastasis, FEV1%\>50% (FEV1: Forced Expiratory Volume in 1 second);

Preoperative imaging:pure ground-glass or mixed ground-glass nodules (part-solid, solid areas \< 0.5cm);

Follow-up duration last 3 months or more, HRCT (HRCT: high-resolution computed tomography) lesion maximum diameter was measured three times and took the average, meet the criteria of clinical surgical indications;

Intraoperative criteria: histologically confirmed NSCLC, adenocarcinoma in situ or with microinvasion;

No prior ipsilateral thoracotomy;

No prior anti-neoplastic therapy;

EOCG Performance status 0-2;

Sufficient organ functions;

Written informed consent.

Exclusion Criteria:

Active bacterial or fungous infection;

Simultaneous or prior (within the past 5 years) other malignant disease;

Interstitial pneumonitis, pulmonary fibrosis, or severe COPD (COPD: chronic obstructive pulmonary disease);

Abnormal Psychosis;

Uncontrollable diabetes mellitus;

History of severe cardiovascular disease;

Any condition which, in the opinion of the investigator might interfere with the evaluation of the objective.

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• BACKGROUNDGinsberg RJ, Rubinstein LV. Randomized trial of lobectomy versus limited resection for T1 N0 non-small cell lung cancer. Lung Cancer Study Group. Ann Thorac Surg. 1995 Sep;60(3):615-22; discussion 622-3. doi: 10.1016/0003-4975(95)00537-u. PMID 7677489
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