Matrix Biology of Tracheobronchomalacia and Tracheal Stenosis

Brief Title

Matrix Biology of Tracheobronchomalacia and Tracheal Stenosis

Official Title

Matrix Biology of Tracheobronchomalacia and Tracheal Stenosis

Brief Summary

      It is not clearly understood what causes tracheobronchomalacia (weakening of the windpipe and
      airways) or tracheal stenosis (narrowing of the windpipe). We plan to take biopsies (small
      pieces of tissue) and brushings (to collect the cells that form the lining of the airway)
      from the airways of patients with these diseases and analyze these samples in a laboratory to
      try and determine the mechanism of disease. We will compare the results with that of patients
      with normal airways.
    

Detailed Description

      -  Controlled pilot study to determine whether there exists, at a molecular level, a
           predisposition to the development of tracheomalacia and subglottic stenosis. Thirty
           patients will be divided into 2 groups of 20 patients (study patients) and 10 patients
           (control group). Both groups will undergo bronchoscopy and airway biopsy

        -  The study is a pilot study to evaluate alterations in the airway matrix, growth factor
           levels, and vascular structures.in patients with tracheobronchomalacia and subglottic
           stenosis

        -  Bronchoscopies will be performed in the West Procedure UnitPulmonary Special Procedures
           Unit or in the operating room (depending on the clinical indication and patient
           scheduling) at the BIDMC after informed consent is obtained.

        -  Patients will receive topical upper airway anesthesia with lidocaine and intravenous
           conscious sedation with fentanyl and midazolam as per standard of care

        -  Biopsies will be performed according to standard protocols.

        -  Biopsies will be performed: 2 samples will be sent for pathology as part of clinical
           care and 2-3 samples used for research analysis.
    


Study Type

Observational




Condition

Tracheobronchomalacia


Study Arms / Comparison Groups

 1
Description:  10 patients with tracheobronchomalacia

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

16

Start Date

July 2008

Completion Date

April 2011

Primary Completion Date

April 2011

Eligibility Criteria

        Inclusion Criteria:

          -  (study group): age ≥ 18, willingness and ability to give informed consent, clinical
             indication for bronchoscopy and biopsy, prior bronchoscopic diagnosis of
             tracheobronchomalacia, prior bronchoscopic diagnosis of subglottic stenosis (either
             idiopathic or post-intubation), and smoking cessation for ≥ 4 months. There is no
             gender or racial restriction. Pregnant women will not be included in the study because
             of the potential for hypoxemia (especially fetal) and prolongation of the procedure if
             complications arise. Patients must have family/friends to drive them home following
             the procedure.

          -  (control group): age ≥ 18, willingness and ability to give informed consent, clinical
             indication for bronchoscopy and biopsy, no prior diagnosis of any airway disease of
             any etiology, and smoking cessation for ≥ 4 months. There is no gender or racial
             restriction. Pregnant women will not be included in the study because of the potential
             for hypoxemia (especially fetal) and prolongation of the procedure if complications
             arise. Patients must have family/friends to drive them home following the procedure.

        Exclusion Criteria:

          -  (study group): pre-existing airway disorders other than tracheobronchomalacia or
             subglottic stenosis, etiology of subglottic stenosis other than idiopathic or
             post-intubation, pulmonary vascular disease, inability to tolerate intravenous
             conscious sedation.

          -  (control group): any pre-existing airway disorder, pulmonary vascular disease, and
             inability to tolerate intravenous conscious sedation.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Sidhu Gangadharan, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00705848

Organization ID

2007P000336


Responsible Party

Principal Investigator

Study Sponsor

Beth Israel Deaconess Medical Center


Study Sponsor

Sidhu Gangadharan, M.D., Principal Investigator, Beth Israel Deaconess Medical Center


Verification Date

March 2017