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Clinical Trials/NCT02299830
NCT02299830
Unknown
Not Applicable

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

Tang-Du Hospital1 site in 1 country200 target enrollmentDecember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Airway Obstruction
Sponsor
Tang-Du Hospital
Enrollment
200
Locations
1
Primary Endpoint
percentage of the cases that got Ⅰand Ⅱlevel remission
Last Updated
11 years ago

Overview

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
Registry
clinicaltrials.gov
Start Date
December 2014
End Date
December 2017
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Tang-Du Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

percentage of the cases that got Ⅰand Ⅱlevel remission

Time Frame: the next day after the treatment

Secondary Outcomes

  • Karnofsky Physical scales(the next day after the treatment)
  • the values of dyspnea index(the next day after the treatment)

Study Sites (1)

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