Effectiveness, Adverse Event Rates and Patient Tolerability of ERCP With Conscious Sedation Versus Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,174
- 试验地点
- 1
- 主要终点
- procedural success of ERCP
研究概览
简要总结
Studies directly comparing EDCS with AAS during ERCP are scarce, varying widely in their designs and reaching conflicting conclusions regarding safety and effectiveness. The investigators will assess, via a multi-center prospective study, the success, adverse event rates, and patient tolerability of ERCP when performed under AAS versus EDCS.
详细描述
- Background and Rationale
Endoscopic retrograde cholangiopancreatography (ERCP) is critical in the diagnosis and therapy of pancreatico-biliary conditions. In contrast to routine upper and lower gastrointestinal (GI) endoscopic procedures, ERCP has several unique characteristics that require consideration when formulating a sedation plan. Factors such as patient comorbidities, positioning, airway issues, and longer procedure times collectively contribute to a high risk of sedation-related adverse events (SRAEs) during ERCP.
In contrast to the United States (US), where anesthetist-administered sedation (AAS) for ERCP is the norm, endoscopist-directed conscious sedation (EDCS) remains the primary method of sedation for ERCP in the United Kingdom (UK), Canada, and other countries with publicly funded national healthcare systems. This practice is largely driven by resource availability and cost limitations. AAS typically involves either general endotracheal anesthesia (GEA) or deep sedation without an endotracheal tube, often referred to as monitored anesthesia care (MAC).
Studies directly comparing EDCS with AAS during ERCP are scarce, varying widely in their designs and reaching conflicting conclusions regarding safety and effectiveness. Furthermore, little is known regarding the sedation method as it relates to procedure-related adverse events (AEs). Finally, patient-reported experience measures (PREMs) in this field have been insufficiently studied to date. The heterogenous nature and inconsistent findings of existing studies comparing AAS and EDCS necessitate further study with data of higher quality and granularity. 2. Research Question and Objectives
The investigators will assess, via a multi-center prospective study, the success, adverse event rates, and patient tolerability of ERCP when performed under AAS versus EDCS. 3. Methods
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
- •Subject referred for ERCP for biliary indication;
- •Subject has not undergone prior ERCP, sphincterotomy, and/or sphincteroplasty;
- •Subject age 18 years or older;
- •Subject able to give informed consent to involvement be included.
排除标准
- •Subject has a standard contraindication to ERCP;
- •Subject or surrogate unable or unwilling to provide informed consent;
- •Subject age < 18 years;
- •Pancreatic indication for ERCP;
- •Morbid obesity;
- •Known history of difficult sedation and/or failed medical procedure(s), endoscopy or other, using EDCS;
- •Planned cholangioscopy.
结局指标
主要结局
procedural success of ERCP
时间窗: 1 day
Defined using a previously published set of a priori criteria by indication (Forbes et al. BMC Gastroenterology 2020; 20:64).
次要结局
- post-ERCP pancreatitis(30 days)
- post-ERCP bleeding(30 days)
- patient tolerability(1 day)
- post-ERCP cholangitis(30 days)