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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
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.
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.
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|