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

NCT07564557 | Recruiting DMC

• 1 other identifier: IS26028
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid-dominant Lung Cancer; Non-small Cell Lung Cancer; Early-stage Lung Cancer; Deep-seated Lung Nodules

Keywords

Septum-guided Segmentectomy; Intersegmental Septum; VATS Segmentectomy; Precision Surgery; Lung-sparing Surgery; Anatomical Boundary; SGS2512

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (1)

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.

Procedure: Septum-guided Segmentectomy

Interventions

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.

Septum-guided Segmentectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 38969057 BACKGROUND

• 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.

  PMID: 35461558 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Junfeng Gen, MD

CONTACT

+8618017321501; drgengjunfeng@163.com

Qing Wang, MD, PhD

CONTACT

+8618516349006; pillawang@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician, Department of Thoracic Surgery

Model Details: 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 。

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: May 4, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): April 1, 2031
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 6 months and ending 36 months following article publication.
• 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.

Locations

CN (1)