Septum-guided Segmentectomy for Deep Early-stage Lung Cancer (SGS2512) (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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-small Cell Lung Cancer; Early-stage Lung Cancer; Deep-seated Lung Nodules; Solid-dominant Lung Cancer
• Intervention / Treatment: Procedure: Septum-guided Segmentectomy

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).

• Study Type: Interventional
• Enrollment (Estimated): 89
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Junfeng Gen, MD; Phone Number: +8618017321501; Email: drgengjunfeng@163.com
• Study Contact Backup: Name: Qing Wang, MD, PhD; Phone Number: +8618516349006; Email: pillawang@163.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200030
      • Recruiting
      • Shanghai Chest Hospital
      • Contact: Qing Wang; Phone Number: 18516349006; Email: pillawang@163.com
      • Contact: Junfeng Geng, MD; Phone Number: +8618017321501; Email: drgengjunfeng@163.com
      • Principal Investigator: Junfeng Geng, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Procedure: Septum-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): April 1, 2031

Study Registration Dates

• First Submitted: April 12, 2026
• First Submitted That Met QC Criteria: April 26, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 26, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Septum-guided Segmentectomy; Intersegmental Septum; VATS Segmentectomy; Precision Surgery; Lung-sparing Surgery; Anatomical Boundary; SGS2512
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: IS26028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning 6 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: Proposals should be directed to the corresponding author (Junfeng Geng). To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No