About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-80 years
Clinical stage IA (cT1a-bN0M0)
tumor diameter ≤ 2 cm
Pathological feature: Solid-dominant lesion (CTR > 0.5)
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Septum-guided Segmentectomy
Procedure/SurgeryThis 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Operation time
The total duration of the surgical procedure, measured from the initial skin incision to the completion of skin closure.
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.
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).
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.
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