Study of Interventional Pulmonologic Treatment of Benign Central Airway Fibrotic Stricture
NCT ID: NCT02287389
Last Updated: 2014-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
160 participants
INTERVENTIONAL
2014-12-31
2017-12-31
Brief Summary
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The four techniques areļ¼
* balloon dilation
* balloon dilation plus cryotherapy
* balloon dilation plus spiculiform electrosurgery
* balloon dilation plus mitomycin C injection
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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balloon dilation
give the cases balloon dilation as the intervention
balloon dilation
balloon dilation plus cryotherapy
give the cases balloon dilation plus cryotherapy as the intervention
balloon dilation
cryotherapy
BD plus spiculiform electrosurgery
give the cases balloon dilation plus spiculiform electrosurgery as the intervention
balloon dilation
spiculiform electrosurgery
BD plus mitomycin C
give the cases Balloon dilation plus mitomycin C as the intervention
balloon dilation
mitomycin C
Interventions
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balloon dilation
cryotherapy
spiculiform electrosurgery
mitomycin C
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
The First Affiliated Hospital of Guangzhou Medical University
OTHER
Xinqiao Hospital of Chongqing
OTHER
China Meitan General Hospital
OTHER
Micro-Tech (Nanjing) Co., Ltd.
INDUSTRY
Tang-Du Hospital
OTHER
Responsible Party
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Principal Investigators
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Faguang Jin, PhD
Role: PRINCIPAL_INVESTIGATOR
Tang-Du Hospital
Locations
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Tangdu Hospital
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NO.201402024
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CAO-NO.201402024-benign
Identifier Type: -
Identifier Source: org_study_id