Study of Interventional Pulmonologic Treatment of Benign Central Airway Fibrotic Stricture

Not Applicable

• Conditions: Obstructive Airway Disease
• Interventions: Device: balloon dilation; Drug: mitomycin C; Procedure: spiculiform electrosurgery; Procedure: cryotherapy

• Registration Number: NCT02287389
• Lead Sponsor: Tang-Du Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-26
• Status Verified: 2014-11
• Study First Submitted QC: 2014-11-07
• Last Update Submitted: 2014-11-07
• Study First Posted: 2014-11-10
• Last Update Posted: 2014-11-10
• Study Start: 2014-12
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BD plus mitomycin C	mitomycin C	give the cases Balloon dilation plus mitomycin C as the intervention
BD plus mitomycin C	balloon dilation	give the cases Balloon dilation plus mitomycin C as the intervention
balloon dilation	balloon dilation	give the cases balloon dilation as the intervention
BD plus spiculiform electrosurgery	spiculiform electrosurgery	give the cases balloon dilation plus spiculiform electrosurgery as the intervention
balloon dilation plus cryotherapy	cryotherapy	give the cases balloon dilation plus cryotherapy as the intervention
balloon dilation plus cryotherapy	balloon dilation	give the cases balloon dilation plus cryotherapy as the intervention
BD plus spiculiform electrosurgery	balloon dilation	give the cases balloon dilation plus spiculiform electrosurgery as the intervention

Primary Outcome Measures

Name	Time	Method
percentage of the cases that got Ⅰand Ⅱlevel remission	3 months

Secondary Outcome Measures

Name	Time	Method
the values of dispnea index	3 months
Karnofsky Physical scales	3 months

Trial Locations

Locations (1)

Tangdu Hospital; 🇨🇳 Xi'an, Shaanxi, China