RecruitingNot ApplicableNCT06275269

Endoscopic Mucosal Injection Versus Ultrasound-Guided Injection of 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.


Sponsor

China-Japan Friendship Hospital

Enrollment

40 participants

Start Date

Mar 10, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria2

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

Exclusion Criteria9

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  • : "Participation in other studies within the last three months and not withdrawn or concluded, or having received triamcinolone treatment less than 1 month ago."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

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Interventions

PROCEDUREUltrasound-Guided

Ultrasound-Guided Triamcinolone Injection

PROCEDURETranslaryngeal Endoscopic Mucosal Injection

Translaryngeal Endoscopic Mucosal Injection of Triamcinolone


Locations(1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

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NCT06275269


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