Comparing two surgical approaches for treating multiple 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

This study is testing if a new combined surgery method for treating multiple lung nodules can lead to fewer complications and a better recovery compared to the traditional surgery approach.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 172 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Ruijin Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05662553 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of electromagnetic navigation bronchoscopy (ENB) guided microwave ablation (MWA) combined with video-assisted thoracic surgery (VATS) versus sequential surgery for patients with synchronous bilateral multiple primary lung nodules. Participants will be randomly assigned to one of two treatment groups: one receiving the combined ENB guided MWA and VATS approach, and the other undergoing sequential surgery. The study aims to determine if the combined approach can reduce complications and improve postoperative quality of life compared to traditional sequential surgery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 diagnosed with synchronous bilateral multiple primary lung nodules that can be treated with radical surgery.

Not a fit: Patients with contraindications to surgery or anesthesia, or those unable to undergo bronchoscopy, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a safer and more effective treatment option for patients with multiple primary lung cancer.

How similar studies have performed: Previous studies have shown promising results for similar approaches, indicating potential effectiveness, though this specific combination is being evaluated in a novel context.

Eligibility criteria

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

Where this trial is running

Shanghai, Shanghai

• Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Hecheng LI, PhD, MD — Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
• Study coordinator: Hecheng Li, PhD, MD

Conditions Multiple Primary Lung Cancer; electromagnetic navigation bronchoscopy; microwave ablation; sequential surgery