Study of Interventional Pulmonologic Treatment of Benign Central Airway Fibrotic Stricture

November 7, 2014 updated by: Tang-Du Hospital

Prospective, Randomized, Open, Controlled, Multicenter Stucy of Interventional Pulmonologic Treatment of Benign Central Airway Fibrotic Stricture

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Tangdu Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: balloon dilation
give the cases balloon dilation as the intervention
Device: balloon dilation
Experimental: balloon dilation plus cryotherapy
give the cases balloon dilation plus cryotherapy as the intervention
Procedure: cryotherapy
Device: balloon dilation
Experimental: BD plus spiculiform electrosurgery
give the cases balloon dilation plus spiculiform electrosurgery as the intervention
Device: balloon dilation
Procedure: spiculiform electrosurgery
Experimental: BD plus mitomycin C
give the cases Balloon dilation plus mitomycin C as the intervention
Drug: mitomycin C
Device: balloon dilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
percentage of the cases that got Ⅰand Ⅱlevel remission
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
the values of dispnea index
Time Frame: 3 months
3 months
Karnofsky Physical scales
Time Frame: 3 months
3 months

Other Outcome Measures

Outcome Measure
Time Frame
adverse event during the treatment
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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.

Investigators

  • Principal Investigator: Faguang Jin, PhD, Tang-Du Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

October 26, 2014

First Submitted That Met QC Criteria

November 7, 2014

First Posted (Estimate)

November 10, 2014

Study Record Updates

Last Update Posted (Estimate)

November 10, 2014

Last Update Submitted That Met QC Criteria

November 7, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAO-NO.201402024-benign
  • NO.201402024 (Other Grant/Funding Number: Special Fund for Scientific Research in the Public Welfare)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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