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Study of Interventional Pulmonologic Treatment of Benign Central Airway Fibrotic Stricture

Primary Purpose

Obstructive Airway Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
balloon dilation
cryotherapy
spiculiform electrosurgery
mitomycin C
Sponsored by
Tang-Du Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Airway Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Tangdu Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

balloon dilation

balloon dilation plus cryotherapy

BD plus spiculiform electrosurgery

BD plus mitomycin C

Arm Description

give the cases balloon dilation as the intervention

give the cases balloon dilation plus cryotherapy as the intervention

give the cases balloon dilation plus spiculiform electrosurgery as the intervention

give the cases Balloon dilation plus mitomycin C as the intervention

Outcomes

Primary Outcome Measures

percentage of the cases that got Ⅰand Ⅱlevel remission

Secondary Outcome Measures

the values of dispnea index
Karnofsky Physical scales

Full Information

First Posted
October 26, 2014
Last Updated
November 7, 2014
Sponsor
Tang-Du Hospital
Collaborators
Changhai Hospital, The First Affiliated Hospital of Guangzhou Medical University, Xinqiao Hospital of Chongqing, China Meitan General Hospital, Micro-Tech (Nanjing) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02287389
Brief Title
Study of Interventional Pulmonologic Treatment of Benign Central Airway Fibrotic Stricture
Official Title
Prospective, Randomized, Open, Controlled, Multicenter Stucy of Interventional Pulmonologic Treatment of Benign Central Airway Fibrotic Stricture
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tang-Du Hospital
Collaborators
Changhai Hospital, The First Affiliated Hospital of Guangzhou Medical University, Xinqiao Hospital of Chongqing, China Meitan General Hospital, Micro-Tech (Nanjing) Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Airway Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
balloon dilation
Arm Type
Experimental
Arm Description
give the cases balloon dilation as the intervention
Arm Title
balloon dilation plus cryotherapy
Arm Type
Experimental
Arm Description
give the cases balloon dilation plus cryotherapy as the intervention
Arm Title
BD plus spiculiform electrosurgery
Arm Type
Experimental
Arm Description
give the cases balloon dilation plus spiculiform electrosurgery as the intervention
Arm Title
BD plus mitomycin C
Arm Type
Experimental
Arm Description
give the cases Balloon dilation plus mitomycin C as the intervention
Intervention Type
Device
Intervention Name(s)
balloon dilation
Intervention Type
Procedure
Intervention Name(s)
cryotherapy
Intervention Type
Procedure
Intervention Name(s)
spiculiform electrosurgery
Intervention Type
Drug
Intervention Name(s)
mitomycin C
Primary Outcome Measure Information:
Title
percentage of the cases that got Ⅰand Ⅱlevel remission
Time Frame
3 months
Secondary Outcome Measure Information:
Title
the values of dispnea index
Time Frame
3 months
Title
Karnofsky Physical scales
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
adverse event during the treatment
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deguang Mu, PhD
Phone
86-29-84777825
Email
deguang@fmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yandong Nan, MD
Phone
86-29-84717533
Email
nanyandong2008@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faguang Jin, PhD
Organizational Affiliation
Tang-Du Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tangdu Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710038
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deguang Mu, Ph.D
Phone
86-29-84777825
Email
deguang@fmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Deguang Mu, Ph.D

12. IPD Sharing Statement

Learn more about this trial

Study of Interventional Pulmonologic Treatment of Benign Central Airway Fibrotic Stricture

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