Study of Mitomycin-C Application in Laryngotracheal Stenosis

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Laryngeal Stenosis; Subglottic Stenosis; Tracheal Stenosis	Drug: Mitomycin -C; Other: Saline application	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, 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
Study Start Date :	January 2012
Estimated Primary Completion Date :	January 2018
Estimated Study Completion Date :	January 2019

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Mitomycin-C; 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.

Outcome Measures

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Primary Outcome Measures :

1. Time to repeat surgery [ Time Frame: 24 months ]
   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.

Secondary Outcome Measures :

1. Duration of symptom improvement [ Time Frame: 24 months ]
   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.
2. Peak inspiratory flow measurement [ Time Frame: 24 months ]
   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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Katherine Yung, MD	415-353-7323	kyung@ohns.ucsf.edu
Contact: Theresa Apice, RN	415-353-2870	Theresa.Apice@ucsfmedctr.org

Locations

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

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator:	Katherine C Yung, MD	University of California, San Francisco

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT01523275 History of Changes
Other Study ID Numbers:	Laryngotracheal Stenosis
First Posted:	February 1, 2012
Last Update Posted:	May 16, 2016
Last Verified:	May 2016

Keywords provided by University of California, San Francisco:

mitomycin-C; laryngotracheal stenosis; subglottic stenosis; tracheal stenosis; endoscopic airway surgery

Additional relevant MeSH terms:

Constriction, Pathologic; Tracheal Stenosis; Laryngostenosis; Pathological Conditions, Anatomical; Tracheal Diseases; Respiratory Tract Diseases; Laryngeal Diseases; Otorhinolaryngologic Diseases; Respiratory System Abnormalities	Congenital Abnormalities; Mitomycins; Mitomycin; Antibiotics, Antineoplastic; Antineoplastic Agents; Alkylating Agents; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors