Matrix Biology of Tracheobronchomalacia and Tracheal Stenosis

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

Study Description

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

• 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

Groups and Cohorts

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

Biospecimen Retention:   Samples With DNA

Airway biopsies and brushings are to be used for staining and culture, respectively

Eligibility Criteria

• 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

Locations

United States, Massachusetts

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators

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

More Information

• Responsible Party: Sidharta Gangadharan, Associate Professor of Surgery, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT00705848 History of Changes
• Other Study ID Numbers: 2007P000336
• First Posted: June 26, 2008
• 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:

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