Study of Interventional Pulmonologic Treatment of Benign Central Airway Fibrotic Stricture

Tang-Du Hospital

Status: Unknown

Conditions: Obstructive Airway Disease

Treatments: Procedure: cryotherapy; Procedure: spiculiform electrosurgery; Drug: mitomycin C; Device: balloon dilation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02287389

CAO-NO.201402024-benign

NO.201402024 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 4 patient groups

balloon dilation

Experimental group

Description:

give the cases balloon dilation as the intervention

Treatment:

Device: balloon dilation

balloon dilation plus cryotherapy

Experimental group

Description:

give the cases balloon dilation plus cryotherapy as the intervention

Treatment:

Device: balloon dilation

Procedure: cryotherapy

BD plus spiculiform electrosurgery

Experimental group

Description:

give the cases balloon dilation plus spiculiform electrosurgery as the intervention

Treatment:

Procedure: spiculiform electrosurgery

Device: balloon dilation

BD plus mitomycin C

Experimental group

Description:

give the cases Balloon dilation plus mitomycin C as the intervention

Treatment:

Drug: mitomycin C

Device: balloon dilation