Study of Mitomycin-C Application in Laryngotracheal Stenosis

NCT01523275 | Terminated Results

• 1 other identifier: Laryngotracheal Stenosis
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Laryngeal Stenosis; Subglottic Stenosis; Tracheal Stenosis

Keywords

mitomycin-C; laryngotracheal stenosis; subglottic stenosis; tracheal stenosis; endoscopic airway surgery

Outcome Measures

Primary Outcomes (1)

• Time to Repeat Surgery

  Length of time between surgeries for laryngotracheal stenosis during the study

  24 months

Secondary Outcomes (2)

• Duration of Symptom Improvement

  24 months

• Peak Inspiratory Flow Measurement

  3 months

Study Arms (2)

Mitomycin-C

EXPERIMENTAL

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

Saline

PLACEBO COMPARATOR

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

Interventions

Mitomycin -C DRUG

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.

Mitomycin-C

Saline application OTHER

Isotonic saline will be applied to cottonoid pledgets and placed into the patient's radial incisions for 3 minutes as the placebo intervention.

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF - Voice and Swallowing Clinic

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Laryngostenosis; Tracheal Stenosis

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiratory System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Tracheal Diseases

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Jolie Chang
• Organization: University of California, San Francisco

jolie.chang@ucsf.edu

415-353-2203

Study Officials

• Katherine C Yung, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2012
• First Posted: February 1, 2012
• Study Start: August 1, 2012
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: May 22, 2019
• Results First Posted: May 22, 2019

Record last verified: 2019-04

Locations

US (1)