Study of Interventional Pulmonologic Treatment of Malignant Central Airway 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 malignant central airway stricture. The four techniques are： cryotherapy argon plasma coagulation stent snare

Official Title
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Prospective, Open, Multicenter Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture

Conditions
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Airway Obstruction

Intervention / Treatment
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* Procedure: cryotherapy
* Procedure: argon plasma coagulation
* Procedure: stent placement
* Procedure: deletion tumor tissue by snare


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: malignant neoplasm caused central airway stenosis the degree of stenosis is above 50% estimated survival duration is longer than 3 months received 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 malignant neoplasm caused central airway 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cryotherapy<br>give the cases whose central airway stricture were caused by soft neoplasm tissues cryotherapy | Procedure: cryotherapy<br>* use cryotherapy to delete soft neoplasm tissue in the airway<br>|
| Experimental: argon plasma coagulation<br>give the cases whose central airway stricture were caused by hard neoplasm tissues argon plasma coagulation | Procedure: argon plasma coagulation<br>* use argon plasma coagulation to delete hard neoplasm tissue in the airway<br>|
| Experimental: stent<br>give the cases whose central airway stricture were caused by neoplasm compression stent placement | Procedure: stent placement<br>* use stent placement to open the airway compressed by out neoplasm<br>|
| Experimental: snare<br>give the cases whose central airway stricture were caused by polypoid neoplasm tissues snare | Procedure: deletion tumor tissue by snare<br>* use snare to delete polypoid neoplasm tissue in the airway<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 |  | the next day after the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the values of dyspnea index |  | the next day after the treatment | 
| Karnofsky Physical scales |  | the next day after the treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neoplasm, central airway, obstruction