Endoscopic Mucosal Injection Versus Ultrasound-Guided Injection of Triamcinolone to Treat Subglottic Stenosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultrasound-Guided, Translaryngeal Endoscopic Mucosal Injection.
- Who it may be relevant to
- Registry conditions: Subglottic Stenosis. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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.
Overview
This study employs a multicenter, randomized controlled trial method, where patients meeting the inclusion criteria for subglottic stenosis are randomly divided into two groups. These groups are respectively undergoing translaryngeal endoscopic mucosal injection and ultrasound-guided injection of triamcinolone treatment. The comparison will focus on various indicators such as therapeutic effect, incidence of adverse reactions, treatment costs, and hospital resource utilization between the two groups. The safety and effectiveness will be compared to determine the relative merits of the two treatment methods.
Interventions
- Procedure Ultrasound-Guided
Ultrasound-Guided Triamcinolone Injection - Procedure Translaryngeal Endoscopic Mucosal Injection
Translaryngeal Endoscopic Mucosal Injection of Triamcinolone
Primary outcome measures
- Incidence of Short-Term Postoperative Complications [Time frame: one week after intervention]
Secondary outcome measures (1)
- Overall medical expenses incurred by patients [Time frame: one week after intervention]
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."
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- China-Japan Friendship Hospital — Beijing
Identifiers
NCT: NCT06275269 · ZRJY2021-BJ08-04-02