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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of Short-Term Postoperative Complications
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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."
排除标准
- •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- •8: "Participation in other studies within the last three months and not withdrawn or concluded, or having received triamcinolone treatment less than 1 month ago."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."
结局指标
主要结局
Incidence of Short-Term Postoperative Complications
时间窗: one week after intervention
Follow-up on short-term postoperative complications (including pneumothorax, bleeding, wound infection, pain, fever, etc.)
次要结局
- Overall medical expenses incurred by patients(one week after intervention)
研究者
Gang Hou
Principal Investigator
China-Japan Friendship Hospital