Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture

Not Applicable

• Conditions: Airway Obstruction
• Interventions: Procedure: cryotherapy; Procedure: argon plasma coagulation; Procedure: stent placement; Procedure: deletion tumor tissue by snare

• Registration Number: NCT02299830
• 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 malignant central airway stricture.

The four techniques are：

* cryotherapy

* argon plasma coagulation

* stent

* snare

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-26
• Status Verified: 2014-11
• Study First Submitted QC: 2014-11-20
• Last Update Submitted: 2014-11-20
• Study First Posted: 2014-11-24
• Last Update Posted: 2014-11-24
• Study Start: 2014-12
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cryotherapy	cryotherapy	give the cases whose central airway stricture were caused by soft neoplasm tissues cryotherapy
argon plasma coagulation	argon plasma coagulation	give the cases whose central airway stricture were caused by hard neoplasm tissues argon plasma coagulation
stent	stent placement	give the cases whose central airway stricture were caused by neoplasm compression stent placement
snare	deletion tumor tissue by snare	give the cases whose central airway stricture were caused by polypoid neoplasm tissues snare

Primary Outcome Measures

Name	Time	Method
percentage of the cases that got Ⅰand Ⅱlevel remission	the next day after the treatment

Secondary Outcome Measures

Name	Time	Method
Karnofsky Physical scales	the next day after the treatment
the values of dyspnea index	the next day after the treatment

Trial Locations

Locations (1)

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