Septum-guided Segmentectomy for Deep Early-stage Lung Cancer (SGS2512)
Recruiting · NCT07564557 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai Chest Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The purpose of this study is to evaluate the safety and effectiveness of a specialized surgical technique called "Septum-guided Segmentectomy" for treating early-stage lung cancer located deep within the lung tissue.Standard surgery for lung cancer often involves removing an entire lung lobe (lobectomy), which can significantly reduce a patient's breathing capacity. For small tumors, removing only a segment of the lung (segmentectomy) can preserve more healthy tissue. However, for tumors located deep in the lung, traditional segmentectomy is technically challenging and risks leaving cancer cells behind.In this study, surgeons will use the natural anatomical boundaries-the intersegmental veins and their surrounding thin membranes (septa)-as a guide to precisely remove the target lung segment. This "septum-guided" approach aims to ensure the cancer is completely removed while maximizing the preservation of healthy lung function.Participants will be followed for 3 years after surgery to monitor for cancer recurrence and assess their long-term recovery.
Who can take part
Inclusion criteria
- Age 18-80 years
- Clinical stage IA (cT1a-bN0M0)
- tumor diameter ≤ 2 cm
- Pathological feature: Solid-dominant lesion (CTR \> 0.5)
- Tumor location: Deep-seated within the lung parenchyma (inner 2/3), defined as the tumor center being located in the inner 2/3 region of the lung field on axial, coronal, and sagittal CT views
- ECOG Performance Status: 0-1
- Pulmonary function: FEV1 ≥ 60% predicted and DLCO SB ≥ 60% predicted
- Participants must be willing and able to provide written informed consent
Exclusion criteria
- Multiple pulmonary nodules or evidence of distant metastasis
- Intraoperative confirmation of lymph node metastasis (N1/N2) or pleural dissemination
- History of previous ipsilateral lung surgery
- History of other malignant tumors within the past 5 years
- Presence of severe cardiovascular or cerebrovascular diseases that preclude surgical tolerance
- Pregnancy or breastfeeding
Where it is running
1 location listed.
- Shanghai Chest Hospital - Shanghai, Shanghai Municipality, China