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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Primary Lung Cancer
• Intervention / Treatment: Procedure: ENB guided MWA combined with VATS; Procedure: sequential surgery

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 172
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hecheng Li, PhD, MD; Phone Number: +8613917113402; Email: lihecheng2000@hotmail.com
• Study Contact Backup: Name: Dingpei Han, PhD, MD; Phone Number: _18017420216; Email: dmhan1985@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
      • Contact: Hecheng Li, PhD, MD; Phone Number: +8613917113402; Email: lihecheng2000@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ablation; 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.	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.
Active Comparator: Surgery; 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	During operation

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: Sun Yat-sen University; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Tang-Du Hospital
• Investigators: Principal Investigator: Hecheng Li, PhD, MD, Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: December 14, 2022
• First Posted (Actual): December 22, 2022

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 6, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: microwave ablation; electromagnetic navigation bronchoscopy; sequential surgery
• Other Study ID Numbers: RTS-016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No