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

NCT ID: NCT06768853

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2026-12-31

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Model group

During surgery, lymph nodes predicted to be metastatic will be dissected based on the predicted results of the model.

Group Type: EXPERIMENTAL

Lymph node dissection based on the model

Intervention Type: PROCEDURE

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

Guideline group

During surgery, lymph nodes will be dissected based on the NCCN guidelines (2023).

Group Type: ACTIVE_COMPARATOR

Lymph node dissection based on the guidelines

Intervention Type: PROCEDURE

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

Interventions

Lymph node dissection based on the guidelines

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

Intervention Type: PROCEDURE

Lymph node dissection based on the model

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongnan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hexiao Tang, PhD

Role: STUDY_CHAIR

Zhongnan Hospital

Locations

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Countries

China

Central Contacts

Hexiao Tang, PhD

Role: CONTACT

thx1245@sina.com

15102723563 ext. +86

Facility Contacts

Hexiao Tang, PhD

Role: primary

thx1245@sina.com

15102723563 ext. +86

Other Identifiers

20240329

Identifier Type: -

Identifier Source: org_study_id