Status:
NOT_YET_RECRUITING
A Look Back at How Well Interventional Treatments Work for Bronchopleural Fistulas in Patients With Lung Metastases From Osteosarcoma
Lead Sponsor:
Ruijin Hospital
Conditions:
Osteosarcoma Metastatic
Eligibility:
All Genders
Up to 75 years
Brief Summary
Patients with pulmonary metastasis of osteosarcoma complicated with BPF often suffer from massive hemoptysis, refractory pneumothorax and difficult fistula healing due to tumor erosion of bronchial ar...
Eligibility Criteria
Inclusion
- The patient was diagnosed with osteosarcoma by histology or cytology, and pulmonary metastasis with bronchopleural fistula (BPF) was confirmed by imaging (CT/PET-CT);
- Present with clinical symptoms associated with BPF (e.g., hemoptysis, pneumothorax, persistent pleural infection, etc.) that are ineffective or poorly responded to traditional treatments (pharmacologic hemostasis, closed thoracic drainage);
- Angiographically confirmed abnormal bronchial or intercostal artery blood supply to the fistula and anatomy suitable for NBCA with coil embolization;
- Age ≤75 years, ECOG performance status ≤2, and predicted survival ≥3 months.
- Coagulation function was basically normal.
Exclusion
- Had a history of severe allergy or contraindication to NBCA glue, iodine contrast agent or coil materials;
- Severe cardiopulmonary dysfunction (e.g., NYHA class III-IV, FEV1 \< 30% predicted, uncontrolled pulmonary hypertension);
- Angiographic abnormalities of the target vessel anatomy (e.g., severe tortuosity, stenosis, or occlusion) prevented the catheter from safely reaching the target embolization site;
- Active systemic infection (e.g., sepsis, active tuberculosis) or uncontrolled local infection;
- Other major organ failure (Child-Pugh C cirrhosis, eGFR \< 30 mL/min/1.73m²);
- Women who are pregnant or lactating or plan to become pregnant during the study.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06927596
Start Date
May 1 2025
End Date
December 31 2026
Last Update
April 15 2025
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