Study of Mitomycin-C Application in Laryngotracheal Stenosis
| Status: | Recruiting |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2012 |
| End Date: | January 2017 |
| Contact: | Katherine Yung, MD |
| Email: | kyung@ohns.ucsf.edu |
| Phone: | 415-353-7323 |
A Randomized Study of Mitomycin-C Application in the Endoscopic Surgical Treatment of Patients With Laryngotracheal Stenosis
This is a randomized, prospective, double-blind, placebo-controlled clinical trial of the
use of mitomycin-C topical application as an adjunctive treatment in the endoscopic surgical
treatment of patients with laryngotracheal stenosis. We hypothesize that the use of
mitomycin-C improves patient outcome in the endoscopic surgical treatment of laryngotracheal
stenosis.
use of mitomycin-C topical application as an adjunctive treatment in the endoscopic surgical
treatment of patients with laryngotracheal stenosis. We hypothesize that the use of
mitomycin-C improves patient outcome in the endoscopic surgical treatment of laryngotracheal
stenosis.
Obstruction of the upper airway caused by laryngotracheal stenosis (LTS) often results in
severe morbidity and even mortality. Treatment of LTS continues to present a challenge and a
wide array of surgical techniques have been employed. Despite multiple endoscopic and/or
open reconstructive procedures, patients often experience restenosis as a result of the
abnormal wound-healing process that initially instigated the airway obstruction. The high
rate of stenosis relapse has therefore motivated researchers to find new methods to modulate
and control the wound-healing process of the airway. Although other adjuvant treatments such
as steroids and antibiotics have been investigated in LTS, much attention in recent years
has turned to the use of topical mitomycin-C (MMC). As a topical application, MMC has been
shown to inhibit fibroblast proliferation in wound-healing processes. The use of MMC in the
treatment of airway stenosis was first reported in 1998 and is now routinely used in the
endoscopic management of LTS. However, despite numerous animal and human studies, the
benefit of MMC in LTS patients remains questionable. While previously published
retrospective data suggest that the addition of MMC improves outcome, there have been no
prospective studies to directly address the efficacy of MMC in endoscopic LTS surgery. This
study will be the first randomized, prospective, double-blind, placebo controlled clinical
trial designed to investigate the efficacy of MMC as an adjunctive therapy to endoscopic
surgical treatment in patients with LTS. In addition, the study will investigate the
relationship between patient symptoms and objective pulmonary function measurements.
Ultimately, the results of this study may influence the treatment and evaluation of patients
with laryngotracheal stenosis.
severe morbidity and even mortality. Treatment of LTS continues to present a challenge and a
wide array of surgical techniques have been employed. Despite multiple endoscopic and/or
open reconstructive procedures, patients often experience restenosis as a result of the
abnormal wound-healing process that initially instigated the airway obstruction. The high
rate of stenosis relapse has therefore motivated researchers to find new methods to modulate
and control the wound-healing process of the airway. Although other adjuvant treatments such
as steroids and antibiotics have been investigated in LTS, much attention in recent years
has turned to the use of topical mitomycin-C (MMC). As a topical application, MMC has been
shown to inhibit fibroblast proliferation in wound-healing processes. The use of MMC in the
treatment of airway stenosis was first reported in 1998 and is now routinely used in the
endoscopic management of LTS. However, despite numerous animal and human studies, the
benefit of MMC in LTS patients remains questionable. While previously published
retrospective data suggest that the addition of MMC improves outcome, there have been no
prospective studies to directly address the efficacy of MMC in endoscopic LTS surgery. This
study will be the first randomized, prospective, double-blind, placebo controlled clinical
trial designed to investigate the efficacy of MMC as an adjunctive therapy to endoscopic
surgical treatment in patients with LTS. In addition, the study will investigate the
relationship between patient symptoms and objective pulmonary function measurements.
Ultimately, the results of this study may influence the treatment and evaluation of patients
with laryngotracheal stenosis.
Inclusion Criteria:
- Patients with laryngotracheal stenosis, including subglottic stenosis or tracheal
stenosis
- Patients with disease amenable to treatment with endoscopic CO2 laser radial
incisions and balloon dilation
- Age greater than or equal to 18 years
Exclusion Criteria:
- Age less than 18 years
- Pregnancy
- Patients with glottic and supraglottic stenosis
- Patients with disease not amenable to treatment with endoscopic CO2 laser radial
incisions and balloon dilation
- Patients with cartilaginous subglottic or tracheal stenosis
We found this trial at
1
site
San Francisco, California 94115
Principal Investigator: Katherine C Yung, MD
Phone: 415-353-2870
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