Study of Mitomycin-C Application in Laryngotracheal Stenosis - Full Text View

Purpose

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	Intervention
Laryngeal Stenosis Subglottic Stenosis Tracheal Stenosis	Drug: Mitomycin -C Other: Saline application


Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy

Drug Information available for: Mitomycin

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.


Estimated Enrollment:	60
Study Start Date:	January 2012
Estimated Study Completion Date:	January 2019
Estimated Primary Completion Date:	January 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01523275

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


Responsible Party:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT01523275 History of Changes
Other Study ID Numbers:	Laryngotracheal Stenosis
Study First Received:	January 27, 2012
Last Updated:	May 12, 2016
Health Authority:	United States: Institutional Review Board

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 Mitomycin Mitomycins Alkylating Agents Molecular Mechanisms of Pharmacological Action Antibiotics, Antineoplastic Antineoplastic Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 26, 2016