Malignant Airway Obstruction
Conditions
Interventions
experimental group:Precut (except photodynamic therapy and intracavitary radiotherapy) + airway cryotherapy system (Ningbo Senscure Biotechnology Co., Ltd.)
control group:Precut (except photodynamic therapy and intracavitary radiotherapy) + ERBOKRYO CA (ERBE Electromedicine Co., Ltd.)
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years; 2. Above 50% malignant ariway stenosis, or high-risk lesion, or symptoms of airway obstruction (cough, dyspnea, etc.) requiring interventional therapy; 3. Intracavitary or mixed type of stenosis; 4. Subject (or his/her custodian) being able to understand the objective of this study and agree to participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Airway stenosis induced by non-malignant tumor; 2. External compressive stenosis requiring stent implantation as evaluated by investigators; 3. Stenosis at multiple sites; 4. Having received radiotherapy for the stenosis site within 3 months prior to enrollment; 5. Subjects concurrently receiving EGFR, ALK, and ROS1 targeted therapies (excluding those who have developed resistance); 6. Trachea in a diameter of less than 4 mm at the stenosis site; 7. Contraindications for Anesthetics and Sedatives; 8. Contraindications for anticoagulation therapy or history of hemorrhagic disease within 6 months; 9. Serious arrhythmia, serious organ dysfunction leading to inability to tolerate surgical treatment; 10. Having systemic infection; 11. Pregnant or lactating women as well as those preparing for conception; 12. Combined with other serious diseases with expected lifespan < 3 months; 13. Having participated or participating in other drug or device clinical study within 3 months prior to enrollment; 14. Other conditions evaluated by investigators as unsuitable for inclusion in this study, e.g., unsuitable anatomical structure, mental or psychological disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| patency rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Medical Research Council, mMRC;Borg index;Karnofsky score;cryotherapy time; | — |
Countries
China
Contacts
Public ContactYuanlin Song
Zhongshan Hospital, Fudan University
Outcome results
None listed