Septum-guided segmentectomy for deep early-stage lung cancer
Official title: 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
Run by Shanghai Chest Hospital · NCT07564557 · Data updated 2026-11-12
This trial tests a precise septum-guided, lung-sparing surgery to remove small, deep early-stage non-small cell lung cancers in adults while preserving more healthy lung tissue.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 89 (estimated) |
| Sponsor | Shanghai Chest Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | April 1, 2026 |
| Main results expected | April 1, 2031 |
| Study ends | April 1, 2031 |
| Registry record updated | May 4, 2026 |
| Trial ID | NCT07564557 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–80 with clinical stage IA (cT1a-bN0M0), a solid-dominant tumor ≤2 cm located deep in the lung (inner two-thirds), ECOG 0–1, and adequate FEV1 and DLCO (≥60% predicted) are ideal candidates.
✕Probably not a fit
Patients with multiple pulmonary nodules, confirmed lymph node or distant metastasis, prior ipsilateral lung surgery, recent other malignancies, severe cardiovascular/cerebrovascular disease, pregnancy/breastfeeding, or insufficient pulmonary function are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, prospective, single-arm trial uses a septum-guided segmentectomy technique to treat deep-seated, solid-dominant early-stage NSCLC while maximizing lung preservation. Surgeons identify intersegmental veins and the surrounding septa via single-port VATS or robot-assisted thoracic surgery to define precise resection boundaries. An intraoperative second registration with frozen section permits conversion to lobectomy if lymph node metastasis or unsuitable anatomy is found. Participants are followed with scheduled chest CTs, tumor markers, and pulmonary function tests for three years to monitor recurrence and functional outcomes.
Why it matters
Potential benefit: If successful, the technique could remove cancer with safety comparable to lobectomy while preserving more lung function and potentially improving postoperative quality of life.
How similar studies have gone: Segmentectomy has been shown comparable to lobectomy for small peripheral NSCLC, but using intersegmental septum guidance for deep lesions is relatively novel and has limited prior clinical evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Junfeng Gen, MD
- Email: drgengjunfeng@163.com
- Phone: +8618017321501
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.