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Search / Trial NCT05662553

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

Launched by RUIJIN HOSPITAL · Dec 14, 2022

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Electromagnetic Navigation Bronchoscopy Microwave Ablation Sequential Surgery

ClinConnect Summary

This clinical trial is looking at two different ways to treat patients with multiple primary lung cancer nodules in both lungs at the same time. One group of participants will receive a treatment called ENB guided MWA combined with VATS, which uses advanced techniques to target the cancer directly. The other group will undergo sequential surgery, meaning they will have surgeries done one after the other. The main goal is to see which method is safer and more effective for treating these lung nodules.

To be eligible for this trial, participants must be between 18 and 80 years old and have been diagnosed with multiple lung nodules through a special type of imaging called HRCT. They should also have at least one nodule that is confirmed to be cancerous and needs surgery. Participants can expect to be closely monitored throughout the study, and they will need to sign a consent form to join. It’s important to note that individuals with certain health conditions or those who have had recent infections or other cancers may not be able to participate.

Gender

ALL

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

About Ruijin Hospital

Ruijin Hospital, affiliated with Shanghai Jiao Tong University School of Medicine, is a leading medical institution in China recognized for its commitment to advancing healthcare through innovative research and clinical trials. With a strong emphasis on patient-centered care, Ruijin Hospital integrates cutting-edge medical practices with rigorous scientific investigation. The hospital's multidisciplinary teams are dedicated to developing new therapeutic approaches, improving patient outcomes, and contributing to global medical knowledge. As a sponsor of clinical trials, Ruijin Hospital ensures adherence to the highest ethical standards and regulatory compliance, fostering an environment of collaboration and excellence in clinical research.

Locations

Shanghai, Shanghai, China

Patients applied

0 patients applied

Trial Officials

Hecheng LI, PhD, MD

Principal Investigator

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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