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Matrix Biology of Tracheobronchomalacia and Tracheal Stenosis

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ClinicalTrials.gov Identifier: NCT00705848
Recruitment Status : Completed
First Posted : June 26, 2008
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Sidharta Gangadharan, Beth Israel Deaconess Medical Center

Study Description
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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.

Condition or disease
Tracheobronchomalacia Tracheal Stenosis

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 Design
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Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Matrix Biology of Tracheobronchomalacia and Tracheal Stenosis
Study Start Date : July 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

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Groups and Cohorts
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Group/Cohort
1
10 patients with tracheobronchomalacia
2
10 patients with tracheal stenosis
3
10 patients with normal airways (no known airway diseases)


Outcome Measures
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Biospecimen Retention:   Samples With DNA
Airway biopsies and brushings are to be used for staining and culture, respectively

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with tracheobronchomalacia or tracheal stenosis referred to this tertiary care facility
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00705848


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Sidhu Gangadharan, M.D. Beth Israel Deaconess Medical Center
More Information
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Responsible Party: Sidharta Gangadharan, Associate Professor of Surgery, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00705848    
Other Study ID Numbers: 2007P000336
First Posted: June 26, 2008    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sidharta Gangadharan, Beth Israel Deaconess Medical Center:
trachea
malacia
stenosis
Additional relevant MeSH terms:
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Tracheobronchomalacia
Tracheal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Tracheal Diseases
Respiratory Tract Diseases
 Cartilage Diseases
Musculoskeletal Diseases
Bronchial Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities
Connective Tissue Diseases