Non-small Cell Lung Cancer
Conditions
Keywords
lung cancer, mediastinal lymph node
Brief 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.
Detailed description
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. Investigators will randomly divide all enrolled patients into an experimental group and a control group. 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 will calculate the consistency between preoperative prediction results and postoperative pathological results to verify the accuracy of the model. And investigators will evaluate the impact of this new lymph node dissection method on prognosis by comparing the intraoperative blood loss, postoperative complications, disease-free survival, and overall survival between the two groups of patients. Investigators expect that performing lymph node dissection according to the predictive model can lead to better prognosis for patients.
Interventions
PROCEDURELymph node dissection based on the guidelines
During surgery, mediastinal lymph nodes will be dissected based on the NCCN guidelines (2023) .
PROCEDURELymph node dissection based on the model
During surgery, lymph nodes will be dissected based on the predicted lymph node status by the model.
Sponsors
Zhongnan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Consistency rate between preoperative prediction results and postoperative pathological results | 1 week after surgery | Compare postoperative lymph node pathology results with preoperative prediction results |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative recurrence rate | 2 years after surgery | Observe for recurrence within 2 years after surgery |
| Disease-free survival | 2 years after surgery | Follow up after surgery to determine if there is any recurrence or metastasis, and calculate disease-free survival |
| Overall survival | 2 years after surgery | Follow up after surgery to determine if there is death, and calculate overall survival |
| Postoperative complications | 30 days after surgery | Observation of complications within 30 days after surgery |
| Postoperative drainage volume | 2 weeks after surgery | Record postoperative drainage volume |
| Postoperative drainage time | 2 weeks after surgery | Record the time from the end of the surgery to the removal of the drain tube |
| Intraoperative blood loss | During the surgery | Record intraoperative blood loss |
Countries
China
Contacts
Primary ContactHexiao Tang, PhD
Outcome results
None listed