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Topical Mitomycin Application After Laryngotracheal Reconstruction
A Randomized, Double-blind, Placebo-Controlled Trial
Christopher J. Hartnick, MD;
Benjamin E. J. Hartley, MD;
Peter D. Lacy, MD;
James Liu, MD;
Judy A. Bean, PhD;
J. Paul Willging, MD;
Charles M. Myer III, MD;
Robin T. Cotton, MD
Arch Otolaryngol Head Neck Surg. 2001;127:1260-1264.
Objective To explore the effect of mitomycin treatment on the pediatric airway
following laryngotracheal reconstruction.
Design Randomized, double-blind, placebo-controlled trial.
Patients Children aged 2 to 17 years with subglottic or upper tracheal stenosis
undergoing laryngotracheal reconstruction at a single, tertiary care, children's
hospital.
Intervention At the time of extubation or stent removal, the children underwent bronchoscopy
and 0.4 mg/mL (2 mL of a 0.2-mg/mL solution of either mitomycin or an equal
volume of isotonic sodium chloride was directly applied to the subglottic
region for a single application of 2 minutes. These children then underwent
interval endoscopy at 2 weeks, 6 weeks, and 3 months postoperatively for assessment
of their airways.
Results Granulation tissue was graded on a scale of 0 (none) to 4 (near-total
or total occlusion). Videotapes of endoscopies were independently observed
and graded by 3 pediatric otolaryngology fellows with a subsequent interobserver
agreement of 91.6%. The results were then dichotomized to represent 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 Monitoring Committee.
At this time, 13 children had been randomized to the mitomycin-treated arm
of the study and 11 children to the placebo-treated arm. A 2-tailed Fisher
exact test revealed a value of 1.00. The Data Monitoring and Safety Committee
advised that the trial should be stopped because the 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.
From the Departments of Pediatric Otolaryngology (Drs Harnick, Hartley,
Lacy, Liu, Willging, Myer, and Cotton) and Biostatistics (Dr Bean), Children's
Hospital Medical Center, Cincinnati, Ohio. Dr Hartnick is now with Harvard
Medical School, Department of Otolaryngology, Massachusetts Eye and Ear Infirmary,
Boston.
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Arch Otolaryngol Head Neck Surg. 2001;127(10):1289-1291.
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