Clinical trial NCT01523275: Study of Mitomycin-C Application in Laryngotracheal Stenosis
Official title: A Randomized Study of Mitomycin-C Application in the Endoscopic Surgical Treatment of Patients With Laryngotracheal Stenosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Laryngeal Stenosis
Subglottic Stenosis
Tracheal Stenosis
Keywords: mitomycin-C
laryngotracheal stenosis
subglottic stenosis
tracheal stenosis
endoscopic airway surgery
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2012-02-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to Repeat Surgery
timeFrame: 24 months
Secondary outcomes:
measure: Duration of Symptom Improvement
timeFrame: 24 months
measure: Peak Inspiratory Flow Measurement
timeFrame: 3 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF - Voice and Swallowing Clinic
state: California
Study officials:
affiliation: University of California, San Francisco
name: Katherine C Yung, MD
role: PRINCIPAL_INVESTIGATOR
References: