An exploratory study of the efficacy and safety of polyvinyl alcohol embolization microspheres for bronchial artery chemoembolization in the treatment of lung cancer complicated with hemoptysis
- Conditions
- lung cancer
- Registration Number
- ChiCTR2400088812
- Lead Sponsor
- Cardiolink Science Medical Technology Development Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
(1) Age 18-80 years old, gender is not limited;<br>(2) Patients with lung cancer who refuse standard therapy or do not respond to standard therapy with hemoptysis;<br>(3) CT angiography or angiography shows the presence of bronchial arteries or other systemic arteries involved in the blood supply to the tumor<br>(4) Expected survival > 3 months;<br>(5) ECOG score = 2 points;<br>(6) Patients who agree to participate in this study and voluntarily sign the informed consent form.
(1) Patients with severe pulmonary fibrosis and pulmonary hypertension and those with reduced pulmonary circulation blood supply due to various reasons;<br>(2) Patients with uncontrolled skin infection at the puncture site and inability to change the puncture site, systemic infection, high fever (body temperature > 38.5 °C);<br>(3) extensive and uncontrolled extrapulmonary metastatic disease;<br>(4) Patients with poor control of large pleural effusion and pericardial effusion;<br>(5) Patients with severe liver, kidney, heart and lung insufficiency may have severe dehydration and nutritional and metabolic disorders that cannot be corrected in a short period of time<br>or improver;<br>(6) Those who cannot be intubated beyond the selection of intubation during the operation, and completely avoid dangerous blood vessels such as spinal arteries;<br>(7) Lung damage caused by tuberculosis or other causes;<br>(8) Patients requiring emergency intervention to stop bleeding;<br>(9) Patients with a history of bronchial arterial chemoembolization of the target lesion;<br>(10) Patients who cannot tolerate anesthesia, contraindicated or allergic to surgical drugs;<br>(11) Severe liver impairment (AST or ALT more than 3 times the upper limit of normal) or severe renal impairment (creatinine > 1.5<br>times the upper limit of normal);<br>(12) Patients with severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short period of time (prothrombin time> 18<br>s);<br>(13) Patients with white blood cell < 3.0×10^9/L, neutrophil < 1.5×10^9/L, hemoglobin < 80 g/L, red blood cell < 2.0×10^12/L, platelet count < 50×10^9/L (except for patients with hypersplenism and chemotherapy myelosuppression)<br>(14) Pregnant or lactating females;<br>(15) Those who are participating in clinical trials of other medical devices or drugs<br>(16) Other circumstances judged by the investigator to be unsuitable for participating in this clinical trial.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immediate clinical success rate;
- Secondary Outcome Measures
Name Time Method Technical success rate;Device performance evaluation;