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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- 3-year Recurrence-Free Survival (RFS)
研究概览
简要总结
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.
详细描述
This is a single-center, prospective, single-arm clinical trial (SGS2512) designed to validate the oncological safety and technical feasibility of septum-guided segmentectomy for deep-seated, solid-dominant early-stage non-small cell lung cancer (NSCLC).Background: While segmentectomy has been proven comparable to lobectomy for small peripheral NSCLC (≤2 cm), its application for deep-seated lesions (inner 2/3 of the lung) remains controversial. Traditional methods rely on fixed safety margins, which are often difficult to achieve in deep regions without sacrificing excessive lung tissue. This study utilizes the "intersegmental septum" as a natural barrier to define the resection boundary.Key Procedures:Surgical Technique: All procedures are performed via single-port VATS or Robot-assisted Thoracic Surgery (RATS). The core technique involves the identification and exposure of the intersegmental veins and the corresponding septa to guide the separation of the target segment.Intraoperative Second Registration: After surgery begins but before the segment is resected, a second check is performed. If frozen section pathology reveals lymph node metastasis or if the anatomical structure is unsuitable for segmentectomy, the procedure will be converted to a standard lobectomy to ensure patient safety.Follow-up: Patients will undergo regular chest CT scans, tumor marker tests, and pulmonary function tests at 1, 6, 12, 18, 24, 30, and 36 months postoperatively.Statistical Design:
The study uses an A'Hern single-stage design to evaluate the primary endpoint. With a null hypothesis (H0) of 3-year RFS ≤ 81% and an alternative hypothesis (H1) of 3-year RFS ≥ 91%, a total of 89 participants are planned for enrollment to ensure 80 evaluable cases. Data analysis will be performed using R software (version 4.0 or above).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
None (Open Label)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Septum-guided Segmentectomy
Participants with solid-dominant, deep-seated early-stage NSCLC will undergo septum-guided segmentectomy. The core technique involves identifying and utilizing the intersegmental veins and their surrounding fibrous septa as the anatomical boundaries for precise resection. Systemic lymph node sampling or dissection (at least 3 hilar and 3 mediastinal groups) is mandatory for all patients. An intraoperative second registration will be performed to ensure the oncological appropriateness of the procedure before resection.
干预措施: Septum-guided Segmentectomy (Procedure)
结局指标
主要结局
3-year Recurrence-Free Survival (RFS)
时间窗: 3 years post-operation
Percentage of participants who are alive and free of any recurrence (including local, regional, or distant recurrence) at 3 years after the surgery. Recurrence is defined from the date of surgery to the date of first evidence of recurrence by imaging (CT, PET-CT, or MRI) or biopsy.
次要结局
- Operation time(During surgery (Day 0))
- Intraoperative Blood Loss(During surgery (Day 0))
- Incidence of Postoperative Complications(From surgery through 30 days post-operation)
- Technical Success of Septum-guided Segmentectomy(During surgery and up to the availability of the final pathology report (typically within 7 days post-operation))
- Change in Pulmonary Function (FEV1)(Pre-operation, 6 months, and 12 months post-operation)
- Local Recurrence Rate(Up to 3 years post-operation)
研究者
Junfeng Geng
Associate Chief Physician, Department of Thoracic Surgery
Shanghai Chest Hospital