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NCT Number: NCT06275269

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location status: Recruiting

Location contact

Mingming Deng

CONTACT

[email protected]

86 18801336854

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • 8: "Participation in other studies within the last three months and not withdrawn or concluded, or having received triamcinolone treatment less than 1 month ago."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

Treatment and study plan

Ultrasound-Guided

Procedure

Ultrasound-Guided Triamcinolone Injection

Translaryngeal Endoscopic Mucosal Injection

Procedure

Translaryngeal Endoscopic Mucosal Injection of Triamcinolone

Primary outcomes

  1. Incidence of Short-Term Postoperative Complications

    Time frame: one week after intervention

    Follow-up on short-term postoperative complications (including pneumothorax, bleeding, wound infection, pain, fever, etc.)

Secondary outcomes

  1. Overall medical expenses incurred by patients

    Time frame: one week after intervention

    Overall medical expenses incurred

Study contacts

Contact information is provided by the study sponsor or research team.

Gang Hou, PI

CONTACT

[email protected]

01084206250

Mingming Deng, Phd

CONTACT

[email protected]

18801336854

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 23, 2024
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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