Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Primary Lung Cancer | Malignant Neoplasm of Lung - Multiple Primary Sites | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ENB guided MWA combined with VATS | Procedure | — | UNRESOLVED |
| sequential surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ablation
- description
- 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.
- interventionNames
- Procedure: ENB guided MWA combined with VATS
- type
- ACTIVE_COMPARATOR
- label
- Surgery
- description
- 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.
- interventionNames
- Procedure: sequential surgery
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
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