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

Официальное название

Clinical Study on Predicting Mediastinal Lymph Node Metastasis in Patients with Lung Cancer by the Predictive Model Based on Clinical Characteristics and Radiomics

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Lymph node dissection based on the guidelines
  During surgery, mediastinal lymph nodes will be dissected based on the NCCN guidelines (2023) .
• Процедура Lymph node dissection based on the model
  During surgery, lymph nodes will be dissected based on the predicted lymph node status by the model.

Первичные конечные точки

• Consistency rate between preoperative prediction results and postoperative pathological results [Срок оценки: 1 week after surgery]

Вторичные конечные точки (7)

• Postoperative complications [Срок оценки: 30 days after surgery]
• Postoperative recurrence rate [Срок оценки: 2 years after surgery]
• Disease-free survival [Срок оценки: 2 years after surgery]
• Overall survival [Срок оценки: 2 years after surgery]
• Intraoperative blood loss [Срок оценки: During the surgery]
• Postoperative drainage volume [Срок оценки: 2 weeks after surgery]
• Postoperative drainage time [Срок оценки: 2 weeks after surgery]

Критерии участия

Критерии включения

• Age range from 18 to 70 years old;
• Chest CT shows a single pulmonary nodule, which may be adenocarcinoma or squamous cell carcinoma;
• Chest CT shows multiple pulmonary nodules, but preoperative evaluation suggests that pulmonary nodules other than the main lesion are benign;
• 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);
• ECOG score 0-1;
• Preoperative lung function FEV1 ≥ 1.0L and actual/expected value ≥ 80%;
• No contraindications for surgery;
• Technically, lobectomy or segmental resection combined with lymph node dissection can be performed;
• Preoperative plain scan and enhanced chest CT examination;
• The interval between surgery and chest CT, lung function, and electrocardiogram examinations is less than or equal to 28 days;
• The patient signs a written informed consent form.

Критерии исключения

• Chest CT suggests multiple primary lung cancer or metastatic cancer;
• Previous history of thoracic surgery;
• Previous history of malignant tumors;
• History of neoadjuvant therapy;
• A history of severe heart failure, myocardial infarction, cerebral infarction, and pneumonia within 6 months prior to surgery;
• Concurrent active bacterial or fungal infections;
• Severe underlying lung diseases such as interstitial lung disease, pulmonary fibrosis, or emphysema are complicated;
• Concomitant mental illness;
• Pregnant/lactating women.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Диагностика

Центры проведения

Китай · 1 центр

• Zhongnan Hospital of Wuhan University — Ухань

Идентификаторы

NCT: NCT06768853 · 20240329

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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