Actively Recruiting
Comparison of Safety and Costs of Translaryngeal Endoscopic Mucosal Injection Versus Ultrasound-Guided Triamcinolone Injection for Subglottic Stenosis
Led by China-Japan Friendship Hospital ยท Updated on 2025-02-10
40
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two different injection methods of triamcinolone to treat patients with subglottic stenosis, a condition that causes narrowing below the vocal cords and leads to symptoms like breathing difficulties and hoarseness. This multicenter, randomized controlled trial compares the safety, therapeutic effects, side effects, treatment costs, and use of hospital resources between translaryngeal endoscopic mucosal injection and ultrasound-guided injection of triamcinolone. The study aims to determine which injection method offers better outcomes for patients. Participants will be randomly assigned to one of two treatment groups: one receiving ultrasound-guided triamcinolone injections and the other receiving translaryngeal endoscopic mucosal injections of triamcinolone. Both are procedural treatments designed to deliver the medication directly to the affected area in the subglottic region. The trial will monitor these treatments over a short-term period to assess differences in effectiveness and safety. During the study, participants will be observed for short-term postoperative complications one week after the intervention. Researchers will also track the overall medical expenses incurred by patients during that time. Safety and cost outcomes will be compared between the two groups to inform future treatment decisions. Participation includes clinical evaluations and follow-up assessments shortly after treatment, with a total study period extending until the end of 2025.
CONDITIONS
Brief Title
Endoscopic Mucosal Injection Versus Ultrasound-Guided Injection of Triamcinolone to Treat Subglottic Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with subglottic stenosis through laryngoscopic examination or imaging such as CT
- Experiencing symptoms related to subglottic stenosis, including breathing difficulties or hoarseness
- Aged between 18 and 65 years
- Able and willing to participate in the study
You will not qualify if you...
- Severe cardiopulmonary dysfunction or inability to tolerate the procedure
- Allergy to lidocaine, midazolam, triamcinolone, or any components of these
- Pregnant or lactating women
- Unstable angina, congestive heart failure, or severe bronchial asthma
- Severe hypertension, arrhythmias, hemodynamic instability, or severe respiratory failure (PaO2 <60mmHg after oxygen therapy or ventilation)
- Known coagulation dysfunction or inability to stop anticoagulants, antiplatelets, aspirin, or NSAIDs before treatment
- Unwillingness to participate in the study
- Participation in other studies within the past 3 months or triamcinolone treatment within 1 month
- Any condition deemed unsuitable for inclusion by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with follow-up for 1 week
Participants receive either Ultrasound-Guided Triamcinolone Injection or Translaryngeal Endoscopic Mucosal Injection of Triamcinolone to treat subglottic stenosis.
1 treatment visit and 1 follow-up visit
Trial Site Locations
Total: 1 location
1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
Research Team
G
Gang Hou, PI
M
Mingming Deng, Phd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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