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| Name | Class |
|---|---|
| Sun Yat-sen University | OTHER |
| Tang-Du Hospital | OTHER |
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
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The goal of this clinical trial is to evaluate the safety and efficacy of ENB guided MWA combined with VATS versus sequential surgery for synchronous bilateral multiple primary lung nodules. Participants will be divided into two group.One group will accepte treatment of ENB guided MWA combined with VATS,another will accepted sequential surgery.
Lung cancer is one of the most common cancers and the leading cause of cancer-related death worldwide. With the improvement of people's health awareness and the wide application of LDCT and HRCT, the incidence of multiple primary lung cancer is increasing, especially the synchronous bilateral multiple primary pulmonary nodules are the difficulties in the treatment of pulmonary nodules. Bilateral sequential surgery is associated with higher intraoperative risks, higher rates of postoperative complications, and lower postoperative quality of life. At present, a small number of recent retrospective studies have shown that microwave ablation(MWA) guided by electromagnetic navigation bronchoscopy(ENB) combined with video-assisted thoracic surgery(VATS) treatment can effectively treat bilateral multiple primary pulmonary nodules, which not only has a low complication rate, but also can avoid secondary surgery.
Based on previous studies, the research plans to conduct a prospective, multi-center, randomized controlled study to evaluate the safety and efficacy of ENB guided MWA combined with VATS versus sequential surgery for synchronous bilateral multiple primary lung nodules, as well as its potential value as a new treatment option for these participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ablation | Experimental | After randomization, the enrolled patients in this arm should be performed path simulation under ENB with preoperative CT. On the operation day, single-cavity intubation will be carried out first, and the secondary lesion will be reached through the planned path. After that,the biopsy tissue of the lesion will be sent to ROSE for detection. If malignant,the ablation will be performed,and the location, energy and ablation time will be adjusted according to intraoperative CT. After ablation, radical surgery will be performed on the primary lesion. |
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| Surgery | Active Comparator | The control group will undergo VATS treatment on the primary lesion on the day of operation, and will be re-admitted to the hospital after discharge and recovery (3-4 months) for contralateral secondary lesion surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENB guided MWA combined with VATS | Procedure | ENB guide MWA combine ENB, microwave ablation and 3D reconstruction technology, and guide the probe in the airway to the target lesion for ablation therapy, which is safe and effective. For patients with synchronous bilateral multiple primary pulmonary nodules, ENB guide MWA combined with VATS treatment can not only avoid the risk of bilateral surgery, but also complete the "one-stop" treatment, which is a new treatment mode. |
| Measure | Description | Time Frame |
|---|---|---|
| Total perioperative complication rates | Complications refer to operation-related adverse events during and after the operation according to the Clavien-Dindo Classification, including pulmonary infection, Broncho-pulmonary hemorrhage, respiratory failure, pleural effusion, pneumothorax, persistent lung leak, arrhythmia, wound infection, death. | From the time of treatment to one month after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) | Objective response rate(ORR)is the proportion of patients with complete responses and partial responses. | One and three months after ablation |
| Treatment-related side effects |
| Measure | Description | Time Frame |
|---|---|---|
| Biopsy success rate | The percentage of people with successful biopsy. | During operation |
| Biopsy positive rate | The proportion of patients with malignant biopsies in the overall population |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hecheng Li, PhD, MD | Contact | +8613917113402 | lihecheng2000@hotmail.com | |
| Dingpei Han, PhD, MD | Contact | _18017420216 | dmhan1985@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hecheng LI, PhD, MD | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| ID | Term |
|---|---|
| D020775 | Thoracic Surgery, Video-Assisted |
| ID | Term |
|---|---|
| D013906 | Thoracoscopy |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
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| sequential surgery | Procedure | Bilateral surgery is a traditional treatment, but it will lead to increased intraoperative risk and postoperative complication rate, and more likely to lead to postoperative complications such as decreased quality of life and cardiopulmonary dysfunction. |
|
Number of participants with treatment-related adverse events as assessed by CTCAE 5.0.
| From the time of treatment to one month after operation |
| The operation time | the duration of the operation in minutes. | During operation |
| The intraoperative blood loss | the volume of blood loss in ml. | During operation |
| Postoperative hospital stay (days) | The time of hospitalization in days. | One months after treatment |
| Postoperative extubation time (days) | The duration of chest drainage in days. | One months after treatment |
| Mortality within 30 days after surgery | number of death within 30 days after surgery. | One month after treatment |
| Complications (grade ≥3) | complications above grade 3 that need to be treated during and after the operation according to the Clavien-Dindo Classification. | One and three months after treatment |
| Life expectancy(EORTC QLQ-LC29) | patients' quality of life by questionnaires according to EORTC QLQ-LC29. | One and three months and every year after treatment |
| Lung function | forced expiratory volume in one second(FEV1). | One and three months and every year after treatment |
| 3-year disease-free survival(DFS) | DFS : the time from surgical resection to clinically confirmed local recurrence, distant metastasis, second primary tumor diagnosis, or patient death (control group since the second operation). | A follow-up period of 3 years |
| The proportion of completed two operations | the patients in control group complete two operations | During operation, an average of 4 months |
| The overall cost of treatment | The overall cost of treatment include direct and indirect costs. Additional costs for hospitalization and surgery. | During hospitalization, an average of 2 weeks |
| During operation |
| D003933 | Diagnosis |
| D020535 | Video-Assisted Surgery |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019616 | Thoracic Surgical Procedures |