Study of Mitomycin-C Application in 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.
Drug: Mitomycin -C
Other: Saline application
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized Study of Mitomycin-C Application in the Endoscopic Surgical Treatment of Patients With Laryngotracheal Stenosis|
- Time to repeat surgery [ Time Frame: 24 months ] [ Designated as safety issue: No ]This study will determine if the addition of topical mitomycin-C increases the duration of time to repeat surgery in patients undergoing endoscopic surgical treatment for laryngotracheal stenosis.
- Duration of symptom improvement [ Time Frame: 24 months ] [ Designated as safety issue: No ]The study will determine if the addition of topical mitomycin-C will increase the duration of symptom improvement in patients undergoing endoscopic surgical treatment for laryngotracheal stenosis.
- Peak inspiratory flow measurement [ Time Frame: 24 months ] [ Designated as safety issue: No ]The study will determine if the addition of topical mitomycin-C will increase the duration of PIF improvement in patients undergoing endoscopic surgical treatment for laryngotracheal stenosis.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Patients will undergo standard endoscopic surgical treatment for LTS involving CO2 laser radial incisions and balloon dilation, as well as topical application of MMC in the radial incisions.
Drug: Mitomycin -C
Topical mitomycin-C at a dosage of 0.4mg/ml will be applied to cottonoid pledgets and placed into the radial incisions for 3 minutes.
Placebo Comparator: Saline
Patients will undergo standard endoscopic surgical treatment for LTS involving CO2 laser radial incisions and balloon dilation, as well as topical application of isotonic saline in the radial incisions.
Other: Saline application
Isotonic saline will be applied to cottonoid pledgets and placed into the patient's radial incisions for 3 minutes as the placebo intervention.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01523275
|Contact: Katherine Yung, MDfirstname.lastname@example.org|
|Contact: Theresa Apice, RN||415-353-2870||Theresa.Apice@ucsfmedctr.org|
|United States, California|
|UCSF - Voice and Swallowing Clinic||Recruiting|
|San Francisco, California, United States, 94115|
|Contact: Theresa Apice, RN 415-353-2870 Theresa.Apice@ucsfmedctr.org|
|Principal Investigator: Katherine C Yung, MD|
|Sub-Investigator: Mark S Courey, MD|
|Principal Investigator:||Katherine C Yung, MD||University of California, San Francisco|