Central airway space-occupying lesion
Conditions
Interventions
test group:Receive super-selective arterial embolization (BAE) + endobronchial treatment (argon knife, electric snare ligation, etc.)
control group:Receive simple endobronchial treatment (argon gas knife, electric snare ligation, etc.)
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) A single airway occupying space that is confirmed by chest imaging or conventional bronchoscopy and requires endobronchial endobronchoscopy, and there is a solid tumor with arterial blood supply; 2) Patients who have no indications for surgery or who refuse surgery and who can undergo bronchoscopic interventional treatment after evaluation; 3) Age: 18-80 years old, male or female; 4) Hematology, biochemistry and organ function: absolute neutrophil count (ANC) =1.5 x 109/L, platelets =100 x 109/L, hemoglobin =90 g/L. International normalized ratio (INR) or prothrombin time (PT) =1.5 ULN. Activated partial thromboplastin time (aPTT) =1.5 ULN. Serum total bilirubin =1.5 ULN. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5 ULN; 5) Expected survival = 6 months; 6) Subjects voluntarily join this study, sign informed consent, have good compliance, and cooperate with follow-up visits
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating women; 2) After CT enhancement, it can be seen that the lesion is of vascular origin or there are aneurysm-like changes inside and outside the lesion, or there is no obvious arterial blood supply after CT enhancement; 3) The patient has contraindications to bronchoscopy or general anesthesia; 4) Anyone with severe allergies to research embolization materials or contrast media; 5) Creatinine clearance <45mL/min; 6) Patients with active viral hepatitis who need treatment as determined by the researcher. Severe chronic or active infections that require systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection; 7) Patients who are currently participating in or participated in other clinical trials within 4 weeks before surgery; 8) Patients who, according to the researcher's judgment, have concomitant diseases that seriously endanger patient safety or affect the patient's completion of the study; 9) Patients with mental illness or history of psychotropic drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of severe bleeding events during endobronchial endobronchial treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of bleeding events during endobronchial endobronchial treatment (incidence of = grade 2 bleeding events);Operation time of endobronchial endobronchial treatment;Changes in the dosage of anesthetics and hemostatic drugs during surgery;Incidence of short-term and long-term postoperative bleeding events;Improvement of airway stenosis (1 month, 3 months, 6 months) and dyspnea; | — |
Countries
China
Contacts
Public ContactSen Jiang
Shanghai Pulmonary Hospital
Outcome results
None listed