Comparing two methods of injecting triamcinolone to treat subglottic stenosis

Comparison of the Safety and Economics of Translaryngeal Endoscopic Mucosal Injection Versus Ultrasound-Guided Injection of Triamcinolone for the Treatment of Subglottic Stenosis: a Multicenter, Randomized Controlled Study.

This study is testing two different ways to inject a medication for people with subglottic stenosis to see which method works better and is safer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: China-Japan Friendship Hospital (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06275269 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multicenter, randomized controlled trial that aims to compare the effectiveness and safety of two different injection techniques for treating subglottic stenosis: translaryngeal endoscopic mucosal injection and ultrasound-guided injection of triamcinolone. Patients diagnosed with subglottic stenosis will be randomly assigned to one of the two treatment groups. The study will evaluate various outcomes, including therapeutic effects, adverse reactions, treatment costs, and hospital resource utilization, to determine which method is superior. The goal is to provide evidence-based recommendations for the best treatment approach for this condition.

Who should consider this trial

Good fit: Ideal candidates for this study are patients diagnosed with subglottic stenosis who are experiencing related symptoms such as breathing difficulties or hoarseness.

Not a fit: Patients with severe cardiopulmonary dysfunction or those who are unable to tolerate the procedure will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from subglottic stenosis.

How similar studies have performed: While there have been studies on triamcinolone injections for various conditions, this specific comparison of injection techniques for subglottic stenosis is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 1: "Diagnosed with subglottic stenosis through laryngoscopic examination or imaging studies such as CT."
* 2: "Experiencing symptoms related to subglottic stenosis, such as breathing difficulties, hoarseness, etc."

Exclusion Criteria:

* 1: "Severe cardiopulmonary dysfunction, patients extremely debilitated and unable to tolerate the procedure."
* 2: "Patients allergic to lidocaine, midazolam, triamcinolone, or any of their components."
* 3: "Pregnant or lactating women."
* 4: "Unstable angina, congestive heart failure, severe bronchial asthma."
* 5: "Severe hypertension and arrhythmias, hemodynamically unstable, and severe respiratory failure (PaO2 \<60mmHg after oxygen therapy or mechanical ventilation)."
* 6: "Known coagulation dysfunction, inability to stop anticoagulants, antiplatelet agents, aspirin, or nonsteroidal anti-inflammatory drugs before treatment."
* 7: "Patients do not agree to participate in this study."
* 8: "Participation in other studies within the last three months and not withdrawn or concluded, or having received triamcinolone treatment less than 1 month ago."
* 9: "Researchers believe there are any circumstances making the patient unsuitable for inclusion."

Where this trial is running

Beijing, Beijing Municipality

• China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Gang Hou, PI

Conditions: Subglottic Stenosis, Triamcinolone, Translaryngeal Endoscopic Mucosal Injection, Ultrasound-Guided Injection