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.
Parallel
Pulmonary segmentectomy
Procedure/SurgerySegmentectomy is applied to lung adenocarcinomas with a diameter of 2-3 cm, in which intraoperative frozen pathology confirms a new pathological grade of 1-2.
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the date of surgery to death from any cause. For surviving patients, survival time is censored at the last date when survival was confirmed; the study allows telephone confirmation of survival status, provided that medical records are available. For lost-to-follow-up patients, survival time is censored on the last date when survival was confirmed before the loss of follow-up. For patients diagnosed with non-malignant tumors, the date of surgery is used as the censorship point.
Recurrence-Free Survival (RFS)
Recurrence-Free Survi refers to the time from the date of surgery to the diagnosis of recurrence or death from any cause, whichever occurs first. "Recurrence" includes both cases confirmed by imaging diagnosis and clinical exacerbation (symptomatic aggravation) not confirmed by imaging diagnosis. For the former, the day of imaging examination is regarded as the recurrence date, while for the latter, the day of diagnosing symptomatic deterioration is considered the recurrence date. An increase in tumor marker values alone is not considered an RFS event. When recurrence is confirmed based on the pathological results of a biopsy specimen, if the patient had already been clinically diagnosed with recurrence before, the endpoint is the date of clinical diagnosis; otherwise, it is the biopsy date. The occurrence of other primary cancers is not considered an endpoint, and RFS continues until other events are identified.
Postoperative Respiratory Function
Patients underwent respiratory function tests (forced expiratory volume in 1 second) at 6 months and 12 months postoperatively to assess the differences between baseline respiratory function and that at 6 months and 12 months postoperatively.
Hospitalization Duration
The hospitalization duration was calculated as the median number of days from the date of surgery.
Chest Tube Placement Time
The chest tube placement time is calculated as the median number of days from the surgery date to chest tube removal. If the chest tube is placed after the patient's discharge, the placement time is calculated until the tube is removed. If the patient undergoes a second chest tube placement, the time after replacement is not included in the calculation.
Surgical Time
The surgical time is calculated as the duration from incision to the end of the operation.
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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
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