Septum-guided Segmentectomy for Deep Early-stage Lung Cancer (SGS2512)
Effectiveness and Safety of Septum-guided Segmentectomy in Solid-dominant, Deep-seated Early-stage Non-small Cell Lung Cancer (≤2 cm): A Single-center, Prospective, Single-arm Clinical Trial
Shanghai Chest Hospital
89 participants
Apr 1, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria8
- 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 Criteria6
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
This procedure is performed via single-port VATS or Robot-assisted Thoracic Surgery (RATS). The core technique involves the precise identification of the intersegmental veins and their surrounding fibrous sheath (septum). These natural anatomical boundaries are utilized to guide the separation and resection of the target lung segment. Unlike traditional methods that rely on fixed safety margins, this approach focuses on anatomical planes to ensure oncological safety for deep-seated lesions. Systematic lymph node sampling or dissection of at least 3 hilar and 3 mediastinal groups is mandatory. An intraoperative second registration is conducted to confirm the nodal status and anatomical suitability before finalizing the resection.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07564557