ENB Guided MWA Combined With VATS Versus Sequential Surgery for Synchronous Bilateral Multiple Pr… (NCT05662553) | Clinical Trial Compass
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ENB Guided MWA Combined With VATS Versus Sequential Surgery for Synchronous Bilateral Multiple Primary Lung Nodules
China172 participantsStarted 2023-02-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Aged ≥18 years and ≤80 years;
✓. The subjects are diagnosed synchronous bilateral multiple primary lung nodules by HRCT
✓. The primary nodule is diagnosed as lung cancer by preoperative puncture or multidisciplinary discussion, which can be treated with radical surgery.
✓. At least one secondary lesion (6mm≤diameter≤20mm, CTR\<0.5) is contralateral to the primary nodule，which need treatment after multidisciplinary discussion
✓. The ipsilateral secondary lesions can be treated by sublobar resection at the same time
✓. ECOG PS score 0-1
✓. The subjects participate voluntarily and sign a written informed consent;
Exclusion criteria
✕. Patients have contraindications of surgery or anesthesia
✕. Patients are unable to undergo bronchoscopy
✕. A contralateral secondary lesion is unreachable during ENB planning
✕. There are large blood vessels 2 mm near the contralateral secondary lesion
✕. Patients have severe bleeding tendency and coagulation dysfunction which cannot be improved in a short time
✕. Patients have interstitial pneumonia, pulmonary fibrosis, or severe emphysema
What they're measuring
1
Total perioperative complication rates
Timeframe: From the time of treatment to one month after operation
✕. Patients have diseases,like severe anemia, dehydration, severe nutritional and metabolic disorders, which cannot be cured or improved in a short time
✕. Patients have severe systemic infection and fever (\>38.5°C)