Obstructive Airway Disease
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of four interventional pulmonology techniques for the treatment of fibrotic central airway stricture. The four techniques are： * balloon dilation * balloon dilation plus cryotherapy * balloon dilation plus spiculiform electrosurgery * balloon dilation plus mitomycin C injection
Interventions
Sponsors
Changhai Hospital
The First Affiliated Hospital of Guangzhou Medical University
Xinqiao Hospital of Chongqing
China Meitan General Hospital
Micro-Tech (Nanjing) Co., Ltd.
Tang-Du Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* tracheal incision,intubation or bronchial tuberculosis caused central airway fibrotic stenosis * the degree of stenosis is above 50% * estimated survival duration is longer than 3 months * recieved no treatment one month before * can understand the statement informed consent * agree to enroll in the study
Exclusion criteria
* older than 70 years or younger than 18 years * not fibrotic stenosis * not central airway stenosis * existence of lumina collapse or twisting * severe arrhythmia, myocardial ischemia or hypertensive crisis * coagulation disorders * existence of severe organ disfunction * allergic to anesthesia drugs * refuse to participate the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| percentage of the cases that got Ⅰand Ⅱlevel remission | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| the values of dispnea index | 3 months |
| Karnofsky Physical scales | 3 months |
Other
| Measure | Time frame |
|---|---|
| adverse event during the treatment | 3 months |
Countries
China
Contacts
Primary ContactDeguang Mu, PhD
Backup ContactYandong Nan, MD
Outcome results
None listed