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

February 7, 2025 updated by: Gang Hou, China-Japan Friendship Hospital

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound-Guided Triamcinolone Injection Treatment Group
Ultrasound-Guided Triamcinolone Injection for the Treatment of Subglottic Stenosis
Procedure: Ultrasound-Guided
Ultrasound-Guided Triamcinolone Injection
Experimental: Translaryngeal Endoscopic Mucosal Injection of Triamcinolone Treatment Group
Translaryngeal Endoscopic Mucosal Injection for the Treatment of Subglottic Stenosis
Procedure: Translaryngeal Endoscopic Mucosal Injection
Translaryngeal Endoscopic Mucosal Injection of Triamcinolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.)
one week after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall medical expenses incurred by patients
Time Frame: one week after intervention
Overall medical expenses incurred
one week after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China-Japan Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2024

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 17, 2024

First Submitted That Met QC Criteria

February 17, 2024

First Posted (Actual)

February 23, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 7, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZRJY2021-BJ08-04-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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