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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Chest Hospital

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Septum-guided Segmentectomy

    Procedure/Surgery

    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.

Treatment groups

89 Participants
are divided into 1 treatment group
Group A: Septum-guided SegmentectomyExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
3 years post-operation

Secondary outcomes

1

Operation time

The total duration of the surgical procedure, measured from the initial skin incision to the completion of skin closure.

Time frame
During surgery (Day 0)
2

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.

Time frame
During surgery (Day 0)
3

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).

Time frame
From surgery through 30 days post-operation
4

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.

Time frame
During surgery and up to the availability of the final pathology report (typically within 7 days post-operation)

Other outcomes

Sponsors and contacts

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