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

Not Applicable

Not yet recruiting

• Conditions: Non-small Cell Lung Cancer

• Registration Number: NCT06768853
• Lead Sponsor: Zhongnan Hospital

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-12-29
• Study Start: 2025-01-01
• Study First Submitted QC: 2025-01-06
• Last Update Submitted: 2025-01-06
• Study First Posted: 2025-01-10
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-03-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Postoperative complications	30 days after surgery	Observation of complications within 30 days after surgery
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
Intraoperative blood loss	During the surgery	Record intraoperative blood loss
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

Trial Locations

Locations (1)

Zhongnan Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China