Comparing two surgical approaches for treating multiple lung nodules

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: lihecheng2000@hotmail.com
• Phone: +8613917113402

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.