Study of Mitomycin-C Application in Laryngotracheal Stenosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01523275
First received: January 27, 2012
Last updated: April 24, 2014
Last verified: April 2014
  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:


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 2017
Estimated Primary Completion Date: January 2016 (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
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

No publications provided

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: April 24, 2014
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
Laryngostenosis
Tracheal Stenosis
Congenital Abnormalities
Laryngeal Diseases
Otorhinolaryngologic Diseases
Pathological Conditions, Anatomical
Respiratory System Abnormalities
Respiratory Tract Diseases
Tracheal Diseases
Mitomycin
Mitomycins
Alkylating Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014