This study is a prospective, multicenter randomized controlled trial (RCT) designed to compare the efficacy of segmentectomy and lobectomy for invasive lung adenocarcinoma with a diameter of 2-3 cm and intraoperative frozen section-confirmed IASLC pathological new grade 1-2. The non-inferiority of segmentectomy is primarily evaluated by 5-year relapse-free survival (RFS) and overall survival (OS) after surgery, while secondary endpoints include pulmonary function preservation, perioperative complications, etc. With a planned enrollment of 587 patients over a 3-year recruitment period and a 5-year follow-up, this study aims to identify an optimized surgical approach.
Initial Registration (1.1) 1. Aged 20 to 79 years, regardless of gender. 2. Preoperative CT or PET-CT suggests: ① Imaging diameter of 2-3 cm.
Suspicion of non-small cell lung cancer (NSCLC).
Solitary nodule or concomitant lesions with microinvasion or below.
Primary tumor not located in the middle lobe.
Active bacterial or fungal infection (confirmed by imaging diagnosis or bacteriological examination with fever >38°C).
Multiple active cancers (synchronous or metachronous multiple primary cancers, excluding in situ carcinoma or intramucosal cancer lesions considered cured by local treatment; such lesions are not included in active multiple cancers).
Patients with severe impairment of cardiac, hepatic, or renal function (cardiac function grade 3-4; ALT and/or AST more than 3 times the upper limit of normal; Cr exceeding the upper limit of normal).
Patients with concomitant other malignant tumors or hematological diseases.
Shanghai Pulmonary Hospital, Shanghai, China
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborator
Affiliated Hospital of Nantong University
Collaborator
Huadong Hospital
Collaborator
Anhui Chest Hospital
Collaborator
Ningbo No. 1 Hospital
Collaborator
Ningbo No.2 Hospital
Collaborator
Center hospital of Nanyang
Collaborator
The Affiliated Hospital of Xuzhou Medical University
Collaborator
Huzhou Central Hospital
Collaborator
Anhui Provincial Hospital
Collaborator
Shandong Public Health Clinical Center
Collaborator