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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Septum-guided Segmentectomy | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Septum-guided Segmentectomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year Recurrence-Free Survival (RFS) | 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. | 3 years post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| Operation time | The total duration of the surgical procedure, measured from the initial skin incision to the completion of skin closure. | During surgery (Day 0) |
| Intraoperative Blood Loss | The total volume of blood lost during the surgical procedure, estimated by measuring the volume of suctioned fluid and weighing the surgical sponges. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junfeng Gen, MD | Contact | +8618017321501 | drgengjunfeng@163.com | |
| Qing Wang, MD, PhD | Contact | +8618516349006 | pillawang@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38969057 | Background | Tsubokawa N, Mimae T, Saeki A, Miyata Y, Kanno C, Kudo Y, Nagashima T, Ito H, Ikeda N, Okada M. Feasibility and comparative prognosis of segmentectomy versus lobectomy in centrally located small and solid dominant cN0 non-small cell lung cancer. J Thorac Cardiovasc Surg. 2025 Feb;169(2):427-435.e2. doi: 10.1016/j.jtcvs.2024.06.016. Epub 2024 Jul 3. | |
| 35461558 |
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Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices), will be shared with researchers who provide a methodologically sound proposal.
Beginning 6 months and ending 36 months following article publication.
Proposals should be directed to the corresponding author (Junfeng Geng). To gain access, data requestors will need to sign a data access agreement.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 13, 2026 | Apr 26, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 13, 2026 | Apr 26, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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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 。
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None (Open Label)
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| During surgery (Day 0) |
| Incidence of Postoperative Complications | 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). | From surgery through 30 days post-operation |
| Technical Success of Septum-guided Segmentectomy | 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. | During surgery and up to the availability of the final pathology report (typically within 7 days post-operation) |
| Change in Pulmonary Function (FEV1) | Comparison of the Forced Expiratory Volume in 1 second (FEV1) between preoperative baseline and postoperative follow-ups to assess the preservation of lung function. | Pre-operation, 6 months, and 12 months post-operation |
| Local Recurrence Rate | Incidence of recurrence occurring at the surgical margin, the remaining ipsilateral lung lobe, or the ipsilateral intrathoracic lymph nodes. | Up to 3 years post-operation |
| Saji H, Okada M, Tsuboi M, Nakajima R, Suzuki K, Aokage K, Aoki T, Okami J, Yoshino I, Ito H, Okumura N, Yamaguchi M, Ikeda N, Wakabayashi M, Nakamura K, Fukuda H, Nakamura S, Mitsudomi T, Watanabe SI, Asamura H; West Japan Oncology Group and Japan Clinical Oncology Group. Segmentectomy versus lobectomy in small-sized peripheral non-small-cell lung cancer (JCOG0802/WJOG4607L): a multicentre, open-label, phase 3, randomised, controlled, non-inferiority trial. Lancet. 2022 Apr 23;399(10335):1607-1617. doi: 10.1016/S0140-6736(21)02333-3. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |