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

Not Applicable

Recruiting

• Conditions: Subglottic Stenosis
• Interventions: Procedure: Translaryngeal Endoscopic Mucosal Injection; Procedure: Ultrasound-Guided

• Registration Number: NCT06275269
• Lead Sponsor: China-Japan Friendship Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-17
• Study First Submitted QC: 2024-02-17
• Study First Posted: 2024-02-23
• Study Start: 2024-03-10
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-10
• Primary Completion: 2025-10-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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• 8: "Participation in other studies within the last three months and not withdrawn or concluded, or having received triamcinolone treatment less than 1 month ago."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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Translaryngeal Endoscopic Mucosal Injection of Triamcinolone Treatment Group	Translaryngeal Endoscopic Mucosal Injection	Translaryngeal Endoscopic Mucosal Injection for the Treatment of Subglottic Stenosis
Ultrasound-Guided Triamcinolone Injection Treatment Group	Ultrasound-Guided	Ultrasound-Guided Triamcinolone Injection for the Treatment of Subglottic Stenosis

Primary Outcome Measures

Name	Time	Method
Incidence of Short-Term Postoperative Complications	one week after intervention	Follow-up on short-term postoperative complications (including pneumothorax, bleeding, wound infection, pain, fever, etc.)

Secondary Outcome Measures

Name	Time	Method
Overall medical expenses incurred by patients	one week after intervention	Overall medical expenses incurred

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China