An interventional study of Mitomycin -C and Saline application in Laryngeal Stenosis, Subglottic Stenosis and Tracheal Stenosis, sponsored by University of California, San Francisco. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-22.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
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.
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.
42 studies on the registry are indexed under Tracheal Stenosis; 11 are open to participants now.
This study's enrollment of 15 is below the median of 22 across 24 interventional studies indexed under Tracheal Stenosis.
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Exclusion Criteria:
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
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
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.
Isotonic saline will be applied to cottonoid pledgets and placed into the patient's radial incisions for 3 minutes as the placebo intervention.
Time to Repeat Surgery
Length of time between surgeries for laryngotracheal stenosis during the study
Time frame: 24 months
Duration of Symptom Improvement
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
Time frame: 24 months
Peak Inspiratory Flow Measurement
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.
Time frame: 3 months
Recruited from the UCSF Voice and Swallowing Center clinic from August 1, 2012 to February 1, 2018
| Milestone | Mitomycin C | Saline |
|---|---|---|
| Started | 6 | 9 |
| Completed | 4 | 7 |
| Not completed | 2 | 2 |
| Withdrew: Lost to follow-up | 1 | 2 |
| Withdrew: Withdrawal by subject | 1 | 0 |
Length of time between surgeries for laryngotracheal stenosis during the study
| Months | Saline | Mitomycin-C |
|---|---|---|
| Time to Repeat Surgery | 17.9 ± 15.7 | 17.4 ± 12.8 |
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
| Months | Saline | Mitomycin-C |
|---|---|---|
| Duration of Symptom Improvement | 4.1 ± 6.7 | 6.0 ± 6.4 |
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.
| Liters per second | Saline | Mitomycin-C |
|---|---|---|
| Peak Inspiratory Flow Measurement | 1.1 ± 1.5 | 1.3 ± 0.96 |
Collected over Adverse event data was collected through study completion, which was on average of 2.3 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Saline | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Mitomycin-C | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Categorical(Participants) | Saline | Mitomycin-C | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 6 | 11 |
| >=65 years | 4 | 0 | 4 |
| Age, Continuous(Years of age) | Saline | Mitomycin-C | Total |
|---|---|---|---|
| Mean | 57.1 ± 12.4 | 48 ± 8.3 | 53 ± 11.6 |
| Sex: Female, Male(Participants) | Saline | Mitomycin-C | Total |
|---|---|---|---|
| Female | 9 | 4 | 13 |
| Male | 0 | 2 | 2 |
| Ethnicity (NIH/OMB)(Participants) | Saline | Mitomycin-C | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 2 | 3 |
| Not Hispanic or Latino | 8 | 4 | 12 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Saline | Mitomycin-C | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 8 | 4 | 12 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 2 | 3 |
| Age of Onset(Years) | Saline | Mitomycin-C | Total |
|---|---|---|---|
| Mean | 52.2 ± 13.5 | 44.2 ± 9.2 | 49 ± 12.3 |
| Etiology(Participants) | Saline | Mitomycin-C | Total |
|---|---|---|---|
| Idiopathic | 6 | 5 | 11 |
| Granulomatosis with Polyangiitis | 2 | 1 | 3 |
| Post-Intubation | 1 | 0 | 1 |
| Site(Participants) | Saline | Mitomycin-C | Total |
|---|---|---|---|
| Subglottis | 8 | 5 | 13 |
| Trachea | 1 | 0 | 1 |
| Subglottis and Trachea | 0 | 1 | 1 |
4 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
This study is terminated, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mitomycin
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