Safety and Efficacy of Endoscopic Ultrasound-guided Gallbladder Drainage Under Endoscopist-directed Conscious Sedation: a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Number of participants with sedation-related adverse events during EUS-guided gallbladder drainage
研究概览
简要总结
This prospective single-center study was designed by the investigators to evaluate the feasibility, safety, and efficacy of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) performed under endoscopist-directed conscious sedation in elderly, high-risk patients with acute cholecystitis. The study aims to assess whether conscious sedation represents a viable alternative to deep sedation or general anesthesia in this fragile patient population.
详细描述
Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) has emerged as an effective minimally invasive treatment for acute cholecystitis in patients who are poor surgical candidates. Although the procedure is commonly performed under deep sedation or general anesthesia, many patients eligible for EUS-GBD are elderly and have significant comorbidities, making anesthesia management particularly challenging. Data regarding the use of endoscopist-directed conscious sedation for EUS-GBD remain limited.
The investigators designed this prospective single-center study to evaluate the feasibility, safety, and efficacy of EUS-GBD performed under endoscopist-directed conscious sedation in a cohort of elderly, high-risk patients with acute cholecystitis. The study focuses on procedural outcomes and sedation management, with particular attention to ketamine-based conscious sedation as a potential strategy for minimizing anesthesia-related risks in this vulnerable population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute cholecystitis in patients considered unfit for surgery according to ASA Physical Status classification and clinical judgment.
排除标准
- •age <18 years
- •patients with acute cholecystitis fit for surgery
结局指标
主要结局
Number of participants with sedation-related adverse events during EUS-guided gallbladder drainage
时间窗: from April 2022 to April 2028
Sedation-related adverse events occurring during or immediately after the procedure, including oxygen desaturation (SpO₂ \<90%), hypotension requiring intervention, bradycardia, need for airway support, unplanned conversion to deep sedation or general anesthesia, and procedure interruption due to sedation-related complications.
次要结局
- Number of participants with procedure-related adverse events(April 2022-2028)
研究者
Anna Cominardi
Principal Investigator
Azienda Unita Sanitaria Locale di Piacenza