Deep-seated Lung Nodules, Early-stage Lung Cancer, Non-small Cell Lung Cancer, Solid-dominant Lung Cancer
Conditions
Keywords
Septum-guided Segmentectomy, Intersegmental Septum, VATS Segmentectomy, Precision Surgery, Lung-sparing Surgery, Anatomical Boundary, SGS2512
Brief 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.
Detailed description
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).
Interventions
PROCEDURESeptum-guided Segmentectomy
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.
Sponsors
Shanghai Chest Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
None (Open Label)
Intervention model description
This is a single-center, prospective, single-arm study. All enrolled participants who pass the intraoperative second registration will receive septum-guided segmentectomy. There is no concurrent control group; historical data and JCOG0802 results will serve as benchmarks for oncological safety and effectiveness 。
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year Recurrence-Free Survival (RFS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operation time | During surgery (Day 0) | The total duration of the surgical procedure, measured from the initial skin incision to the completion of skin closure. |
| Intraoperative Blood Loss | During surgery (Day 0) | The total volume of blood lost during the surgical procedure, estimated by measuring the volume of suctioned fluid and weighing the surgical sponges. |
| Incidence of Postoperative Complications | From surgery through 30 days post-operation | The percentage of participants experiencing one or more postoperative complications. Complications will be categorized and graded according to the Clavien-Dindo classification system (focusing on Grade II or higher). |
| Technical Success of Septum-guided Segmentectomy | During surgery and up to the availability of the final pathology report (typically within 7 days post-operation) | Assessment of the surgical quality, including the R0 resection rate (no microscopic tumor cells at the margin) and the intact exposure rate of intersegmental veins. |
| Change in Pulmonary Function (FEV1) | Pre-operation, 6 months, and 12 months post-operation | Comparison of the Forced Expiratory Volume in 1 second (FEV1) between preoperative baseline and postoperative follow-ups to assess the preservation of lung function. |
| Local Recurrence Rate | Up to 3 years post-operation | Incidence of recurrence occurring at the surgical margin, the remaining ipsilateral lung lobe, or the ipsilateral intrathoracic lymph nodes. |
Countries
China
Contacts
CONTACTJunfeng Gen, MD
CONTACTQing Wang, MD, PhD
Outcome results
None listed