Endoscopic Mucosal Injection Versus Ultrasound-Guided Injection of Triamcinolone to Treat Subglottic Stenosis

China-Japan Friendship Hospital

Status: Enrolling

Conditions: Subglottic Stenosis

Treatments: Procedure: Ultrasound-Guided; Procedure: Translaryngeal Endoscopic Mucosal Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06275269

ZRJY2021-BJ08-04-02

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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• 8: "Participation in other studies within the last three months and not withdrawn or concluded, or having received triamcinolone treatment less than 1 month ago."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."

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Ultrasound-Guided Triamcinolone Injection Treatment Group

Experimental group

Description:

Ultrasound-Guided Triamcinolone Injection for the Treatment of Subglottic Stenosis

Treatment:

Procedure: Ultrasound-Guided

Translaryngeal Endoscopic Mucosal Injection of Triamcinolone Treatment Group

Experimental group

Description:

Translaryngeal Endoscopic Mucosal Injection for the Treatment of Subglottic Stenosis

Treatment:

Procedure: Translaryngeal Endoscopic Mucosal Injection