Study of Interventional Pulmonologic Treatment of Benign Central Airway Fibrotic Stricture

Study Overview
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Brief Summary
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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

Official Title
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Prospective, Randomized, Open, Controlled, Multicenter Stucy of Interventional Pulmonologic Treatment of Benign Central Airway Fibrotic Stricture

Conditions
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Obstructive Airway Disease

Intervention / Treatment
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* Device: balloon dilation
* Procedure: cryotherapy
* Procedure: spiculiform electrosurgery
* Drug: mitomycin C


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: balloon dilation<br>give the cases balloon dilation as the intervention | Device: balloon dilation<br> <br> |
| Experimental: balloon dilation plus cryotherapy<br>give the cases balloon dilation plus cryotherapy as the intervention | Device: balloon dilation<br> <br> Procedure: cryotherapy<br> <br> |
| Experimental: BD plus spiculiform electrosurgery<br>give the cases balloon dilation plus spiculiform electrosurgery as the intervention | Device: balloon dilation<br> <br> Procedure: spiculiform electrosurgery<br> <br> |
| Experimental: BD plus mitomycin C<br>give the cases Balloon dilation plus mitomycin C as the intervention | Device: balloon dilation<br> <br> Drug: mitomycin C<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of the cases that got Ⅰand Ⅱlevel remission |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the values of dispnea index |  | 3 months | 
| Karnofsky Physical scales |  | 3 months |