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  • Title: A randomized controlled trial of adjuvant mitomycin-c in endoscopic surgery for laryngotracheal stenosis.
    Author: Yung KC, Chang J, Courey MS.
    Journal: Laryngoscope; 2020 Mar; 130(3):706-711. PubMed ID: 31022311.
    Abstract:
    OBJECTIVES/HYPOTHESIS: Topical mitomycin-C (MMC) application is a commonly accepted adjuvant therapy in the surgical treatment for laryngotracheal stenosis (LTS). However, the efficacy of MMC has not been examined in a prospective, randomized clinical trial in humans. We aimed to examine the efficacy of MMC in the treatment of LTS patients as compared to a placebo-controlled group. STUDY DESIGN: Prospective, randomized, double-blind, placebo-controlled clinical trial. METHODS: Fifteen patients with LTS were enrolled in a 24-month trial and randomized into one of two groups: 1) endoscopic surgical treatment with topical application of MMC or 2) endoscopic surgical treatment with topical application of saline. Postoperatively, patients were evaluated at standardized intervals with a symptom questionnaire and spirometry. Subsequent surgery was performed as needed based on relapse of stenosis on exam and patient-reported symptom severity. RESULTS: The average interval between surgical treatments was 17.9 months in the placebo group and 17.4 months in the MMC group (P = .95). There was no difference in magnitude of peak inspiratory flow (PIF) improvement between groups. The average magnitude of PIF change was 1.3 L/sec and 1.1 L/sec for the placebo and MMC groups, respectively (P = .64). Similarly, there was no difference in magnitude of symptom improvement or duration of symptom improvement between the two groups. CONCLUSIONS: This prospective, randomized. double-blind. placebo-controlled trial suggests that the use of MMC as a topical adjuvant therapy has no additional benefit in the endoscopic surgical management of LTS. Further study is needed. LEVEL OF EVIDENCE: 1b Laryngoscope, 130:706-711, 2020.
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