ENB Guided MWA Combined With VATS Versus Sequential Surgery for Synchronous Bilateral Multiple Primary Lung Nodules

Multiple Primary Lung Cancer Clinical Trial

Official title:

A Prospective, Multi-center, Randomized Controlled Clinical Study of ENB Guided MWA Combined With VATS Versus Sequential Surgery for Synchronous Bilateral Multiple Primary Lung Nodules

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05662553
• Other study ID #: RTS-016
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2023
• Source: Ruijin Hospital
• Contact: Hecheng Li, PhD, MD
• Phone: +8613917113402
• Email: lihecheng2000[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 172
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Aged =18 years and =80 years;

2. The subjects are diagnosed synchronous bilateral multiple primary lung nodules by HRCT

3. The primary nodule is diagnosed as lung cancer by preoperative puncture or multidisciplinary discussion, which can be treated with radical surgery.

4. At least one secondary lesion (6mm=diameter=20mm, CTR<0.5) is contralateral to the primary nodule,which need treatment after multidisciplinary discussion

5. The ipsilateral secondary lesions can be treated by sublobar resection at the same time

6. ECOG PS score 0-1

7. The subjects participate voluntarily and sign a written informed consent;

Exclusion Criteria:

1. Patients have contraindications of surgery or anesthesia

2. Patients are unable to undergo bronchoscopy

3. A contralateral secondary lesion is unreachable during ENB planning

4. There are large blood vessels 2 mm near the contralateral secondary lesion

5. Patients have severe bleeding tendency and coagulation dysfunction which cannot be improved in a short time

6. Patients have interstitial pneumonia, pulmonary fibrosis, or severe emphysema

7. Patients have diseases,like severe anemia, dehydration, severe nutritional and metabolic disorders, which cannot be cured or improved in a short time

8. Patients have severe systemic infection and fever (>38.5°C)

9. Patients have other malignant tumors

10. Patients have participated in other clinical trials

11. Investigators consider the patient do not fit for the study

Related Conditions & MeSH terms

• Multiple Primary Lung Cancer

Intervention

Procedure:
• ENB guided MWA combined with VATS
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.
• sequential surgery
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.

Locations

Country	Name	City	State
China	Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Ruijin Hospital	Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Sun Yat-sen University, Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biopsy success rate	The percentage of people with successful biopsy.	During operation
Other	Biopsy positive rate	The proportion of patients with malignant biopsies in the overall population	During operation
Primary	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
Secondary	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
Secondary	Treatment-related side effects	Number of participants with treatment-related adverse events as assessed by CTCAE 5.0.	From the time of treatment to one month after operation
Secondary	The operation time	the duration of the operation in minutes.	During operation
Secondary	The intraoperative blood loss	the volume of blood loss in ml.	During operation
Secondary	Postoperative hospital stay (days)	The time of hospitalization in days.	One months after treatment
Secondary	Postoperative extubation time (days)	The duration of chest drainage in days.	One months after treatment
Secondary	Mortality within 30 days after surgery	number of death within 30 days after surgery.	One month after treatment
Secondary	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
Secondary	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
Secondary	Lung function	forced expiratory volume in one second(FEV1).	One and three months and every year after treatment
Secondary	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
Secondary	The proportion of completed two operations	the patients in control group complete two operations	During operation, an average of 4 months
Secondary	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