Non-Small Cell Lung Cancer (NSCLC) Clinical Trials

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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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Shanghai Chest Hospital
RECRUITING
Shanghai
Contact Information
Primary
Junfeng Gen, MD
drgengjunfeng@163.com
+8618017321501
Backup
Qing Wang, MD, PhD
pillawang@163.com
+8618516349006
Time Frame
Start Date: 2026-04-01
Estimated Completion Date: 2031-04-01
Participants
Target number of participants: 89
Treatments
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.
Sponsors
Leads: Shanghai Chest Hospital

This content was sourced from clinicaltrials.gov