Study of Mitomycin-C Application in Laryngotracheal Stenosis
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ClinicalTrials.gov Identifier: NCT01523275 |
Recruitment Status :
Terminated
(Due to poor patient accrual, the study was closed prior to reaching the desired study size)
First Posted : February 1, 2012
Results First Posted : May 22, 2019
Last Update Posted : May 22, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Laryngeal Stenosis Subglottic Stenosis Tracheal Stenosis | Drug: Mitomycin -C Other: Saline application | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Study of Mitomycin-C Application in the Endoscopic Surgical Treatment of Patients With Laryngotracheal Stenosis |
Actual Study Start Date : | August 2012 |
Actual Primary Completion Date : | February 2018 |
Actual Study Completion Date : | February 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: 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 MMC in the radial incisions.
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Drug: Mitomycin -C
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. |
Placebo Comparator: Saline
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.
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Other: Saline application
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 [ Time Frame: 24 months ]Length of time between surgeries for laryngotracheal stenosis during the study
- Duration of Symptom Improvement [ Time Frame: 24 months ]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
- Peak Inspiratory Flow Measurement [ Time Frame: 3 months ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01523275
United States, California | |
UCSF - Voice and Swallowing Clinic | |
San Francisco, California, United States, 94115 |
Principal Investigator: | Katherine C Yung, MD | University of California, San Francisco |
Documents provided by University of California, San Francisco:
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT01523275 |
Other Study ID Numbers: |
Laryngotracheal Stenosis |
First Posted: | February 1, 2012 Key Record Dates |
Results First Posted: | May 22, 2019 |
Last Update Posted: | May 22, 2019 |
Last Verified: | April 2019 |
mitomycin-C laryngotracheal stenosis subglottic stenosis tracheal stenosis endoscopic airway surgery |
Tracheal Stenosis Laryngostenosis Constriction, Pathologic Pathological Conditions, Anatomical Tracheal Diseases Respiratory Tract Diseases Laryngeal Diseases Otorhinolaryngologic Diseases Respiratory System Abnormalities |
Congenital Abnormalities Mitomycins Mitomycin Antibiotics, Antineoplastic Antineoplastic Agents Alkylating Agents Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors |