Clinical trial NCT06768853: The Accuracy of Targeted Lymph Node Dissection of Non-small Cell Lung Cancer Patients According to Predictive Models
Official title: Clinical Study on Predicting Mediastinal Lymph Node Metastasis in Patients with Lung Cancer by the Predictive Model Based on Clinical Characteristics and Radiomics
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Non-small Cell Lung Cancer
Keywords: lung cancer
mediastinal lymph node
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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 outcomes:
measure: Consistency rate between preoperative prediction results and postoperative pathological results
timeFrame: 1 week after surgery
Secondary outcomes:
measure: Postoperative complications
timeFrame: 30 days after surgery
measure: Postoperative recurrence rate
timeFrame: 2 years after surgery
measure: Disease-free survival
timeFrame: 2 years after surgery
measure: Overall survival
timeFrame: 2 years after surgery
measure: Intraoperative blood loss
timeFrame: During the surgery
measure: Postoperative drainage volume
timeFrame: 2 weeks after surgery
measure: Postoperative drainage time
timeFrame: 2 weeks after surgery
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Zhongnan Hospital
name: Hexiao Tang, PhD
role: STUDY_CHAIR
References: