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The Accuracy of Targeted Lymph Node Dissection of Non-small Cell Lung Cancer Patients According to Predictive Models

NCT06768853 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2025-01-01
Last updated
2025-01-10

Condition(s) studied

Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Lymph node dissection based on the guidelinesLymph node dissection based on the model

Lymph node dissection based on the guidelines: During surgery, mediastinal lymph nodes will be dissected based on the NCCN guidelines (2023) .

Lymph node dissection based on the model: During surgery, lymph nodes will be dissected based on the predicted lymph node status by the model.

Study summary

Investigators combined the clinical and radiomics characteristics of resectable non-small cell lung cancer patients to construct an accurate model for preoperative prediction of mediastinal lymph node status. For the patients in the experimental group, lymph nodes will be dissected based on the predicted lymph node status by the model, while in the control group, the lymph nodes will be dissected according to the NCCN guidelines (2023). Investigators expect that performing lymph node dissection according to the predictive model can lead to better prognosis for patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age range from 18 to 70 years old; 2. Chest CT shows a single pulmonary nodule, which may be adenocarcinoma or squamous cell carcinoma; 3. Chest CT shows multiple pulmonary nodules, but preoperative evaluation suggests that pulmonary nodules other than the main lesion are benign; 4. Preoperative auxiliary examination evaluates the patient as clinically resectable lung adenocarcinoma or squamous cell carcinoma in stages I, II, or IIIA (UICC-TNM 9th edition); 5. ECOG score 0-1; 6. Preoperative lung function FEV1 ≥ 1.0L and actual/expected value ≥ 80%; 7. No contraindications for surgery; 8. Technically, lobectomy or segmental resection combined with lymph node dissection can be performed; 9. Preoperative plain scan and enhanced chest CT examination; 10. The interval between surgery and chest CT, lung function, and electrocardiogram examinations is less than or equal to 28 days; 11. The patient signs a written informed consent form. Exclusion Criteria: 1. Chest CT suggests multiple primary lung cancer or metastatic cancer; 2. Previous history of thoracic surgery; 3. Previous history of malignant tumors; 4. History of neoadjuvant therapy; 5. A history of severe heart failure, myocardial infarction, cerebral infarction, and pneumonia within 6 months prior to surgery; 6. Concurrent active bacterial or fungal infections; 7. Severe underlying lung diseases such as interstitial lung disease, pulmonary fibrosis, or emphysema are complicated; 8. Concomitant mental illness; 9. Pregnant/lactating women.

Primary outcome measure(s)

  • Consistency rate between preoperative prediction results and postoperative pathological results — 1 week after surgery
    Compare postoperative lymph node pathology results with preoperative prediction results

Trial sites (1)

FacilityCityRegionStatus
Zhongnan Hospital of Wuhan University Wuhan Hubei
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06768853 on ClinicalTrials.gov ↗ ← All trials in China