Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture

Tang-Du Hospital

Status: Unknown

Conditions: Airway Obstruction

Treatments: Procedure: stent placement; Procedure: deletion tumor tissue by snare; Procedure: argon plasma coagulation; Procedure: cryotherapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02299830

NO.201402024 (Other Grant/Funding Number)

CAO-NO.201402024-malignant1

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 malignant central airway stricture.

The four techniques are：

• cryotherapy
• argon plasma coagulation
• stent
• snare

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

cryotherapy

Experimental group

Description:

give the cases whose central airway stricture were caused by soft neoplasm tissues cryotherapy

Treatment:

Procedure: cryotherapy

argon plasma coagulation

Experimental group

Description:

give the cases whose central airway stricture were caused by hard neoplasm tissues argon plasma coagulation

Treatment:

Procedure: argon plasma coagulation

stent

Experimental group

Description:

give the cases whose central airway stricture were caused by neoplasm compression stent placement

Treatment:

Procedure: stent placement

snare

Experimental group

Description:

give the cases whose central airway stricture were caused by polypoid neoplasm tissues snare

Treatment:

Procedure: deletion tumor tissue by snare