Topical mitomycin application after laryngotracheal reconstruction - A randomized, double-blind, placebo-controlled trial

Objective: To explore the effect of mitomycin treatment on the pediatric ai rway following laryngotracheal reconstruction. Design: Randomized, double-blind, placebo-controlled trial. Patients: Children aged 2 to 17 years with subglottic or upper tracheal ste nosis undergoing laryngotracheal reconstruction at a single, tertiary care, children's hospital. Intervention: At the time of extubation or stent removal, the children unde rwent bronchoscopy and 0.4 mg/mL (2 mL of a 0.2-mg/mL solution of either mi tomycin or an equal volume of isotonic sodium chloride was directly applied to the subglottic region for a single application of 2 minutes. These chil dren then underwent interval endoscopy at 2 weeks, 6 weeks, and 3 months po stoperatively for assessment of their airways. Results: Granulation tissue was graded on a scale of 0 (none) to 4 (near-to tal or total occlusion). Videotapes of endoscopies were independently obser ved and graded by 3 pediatric otolaryngology fellows with a subsequent inte robserver agreement of 91.6%. The results were then dichotomized to represe nt a single cohort in which further surgical intervention would be required and another separate cohort in which further surgery would not be required . At the 1-year mark, interim analysis was performed by a Data Safety and M onitoring Committee. At this time, 13 children had been randomized to the m itomycin-treated arm of the study and I I children to the placebo-treated a rm. A 2-tailed Fisher exact test revealed a value of 1.00, The Data Monitor ing and Safety Committee advised that the trial should be stopped because t he distributions between the 2 populations were almost identical. Conclusion: We cannot reject the null hypothesis that a single topical dose of mitomycin exerts an equal benefit as does isotonic sodium chloride when applied to the pediatric airway after laryngotracheal reconstruction.