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

Subglottic Stenosis Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06275269
• Other study ID #: ZRJY2021-BJ08-04-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 10, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: China-Japan Friendship Hospital
• Contact: Gang Hou, PI
• Phone: 01084206250
• Email: hougangcmu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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."

Related Conditions & MeSH terms

• Constriction, Pathologic
• Laryngostenosis
• Subglottic Stenosis

Intervention

Procedure:
• Ultrasound-Guided
Ultrasound-Guided Triamcinolone Injection
• Translaryngeal Endoscopic Mucosal Injection
Translaryngeal Endoscopic Mucosal Injection of Triamcinolone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Short-Term Postoperative Complications	Follow-up on short-term postoperative complications (including pneumothorax, bleeding, wound infection, pain, fever, etc.)	one week after intervention
Secondary	Overall medical expenses incurred by patients	Overall medical expenses incurred	one week after intervention