malignant central airway stenosis
Conditions
Interventions
test group:The stent was implanted with a soft bronchoscope
Control group: The stent is implanted through the guide wire
Sponsors
the First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 year men and women; 2. The participants or legal authorized person known the purpose and procedure of the clinical trial and voluntarily signed the informed consent; 3. the participants diagnosed malignant central airway obstraction, which airway stensis is more than 50% by CT scan and need to be treatment by implanting with airway stent; 4. Female participants in the screening visit is not in the lactation period, beyond 1 year without breastfeeding and pregnancy plan after surgery; 5. Don't tolerate surgery or want surgery.
Exclusion criteria
Exclusion criteria: 1. lesions are near the carina and need implant Y -stent therapy; 2. the diameter of normal airway is more than 20mm; 3. Treated without subjective intention; 4. the distal stenosis condition can not be projected,doctor think the effective of stent treatment is not good; 5. Don't cooperate with surgery or signed preoperative informed consent; 6. Severe arrhythmia, acute myocardial ischemia, uncontrollable hypertensive crisis; 7. Coagulation dysfunction(PT>2N or PLT <50×10^9/L); 8. Severe organ dysfunction (Shock, severe liver and kidney dysfunction, upper gastrointestinal bleeding, DIC, massive hemoptys); 9. Allergy to narcotic drugs; 10. Pregnancy woman.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Operation time of airway stent implantation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effective rate of clinical treatment of airway stenosis;The success rate of the release of the stent once;to evaluate the safety of the stent; | — |
Countries
China
Contacts
Public ContactJian'an Huang
the First Affiliated Hospital of Soochow University
Outcome results
None listed