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Study of Mitomycin-C Application in Laryngotracheal Stenosis

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ClinicalTrials.gov Identifier: NCT01523275
Recruitment Status : Terminated (Due to poor patient accrual, the study was closed prior to reaching the desired study size)
First Posted : February 1, 2012
Results First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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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)
Actual Enrollment : 15 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
Actual Study Start Date : August 2012
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

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Arms and Interventions
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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 ]
    Length of time between surgeries for laryngotracheal stenosis during the study


Secondary Outcome Measures :
  1. Duration of Symptom Improvement [ Time Frame: 24 months ]
    Symptom improvement was measured using the Clinical COPD Questionnaire, a 10-point patient reported symptom score. Duration of symptom improvement was defined as the time from surgery to the time that symptoms to worsened beyond a CCQ score of 1 or the time to the subsequent surgery if CCQ never exceeded 1

  2. Peak Inspiratory Flow Measurement [ Time Frame: 3 months ]
    Change in maximum inspiratory air flow from preoperative value to highest postoperative value within 3 months of surgery. Calculation details: Highest postoperative value within 3 months of surgery minus preoperative value.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01523275


Locations
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United States, California
UCSF - Voice and Swallowing Clinic
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Katherine C Yung, MD University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Study Protocol and Statistical Analysis Plan  [PDF] December 27, 2018

More Information
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01523275    
Other Study ID Numbers: Laryngotracheal Stenosis
First Posted: February 1, 2012    Key Record Dates
Results First Posted: May 22, 2019
Last Update Posted: May 22, 2019
Last Verified: April 2019
Keywords provided by University of California, San Francisco:
mitomycin-C
laryngotracheal stenosis
subglottic stenosis
tracheal stenosis
endoscopic airway surgery
Additional relevant MeSH terms:
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Tracheal Stenosis
Laryngostenosis
Constriction, Pathologic
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