Association Between Peri-procedural Intravenous Hydration and Post- Endoscopic Retrograde Cholangiopancreatography Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 13,000
- 试验地点
- 1
- 主要终点
- post-ERCP pancreatitis
研究概览
简要总结
Aggressive intravenous hydration has been shown in randomized trials to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP), though studied regimens are often impractical. To date, no studies have prospectively assessed short-term (60-90 minute) aggressive hydration regimens that are feasible for outpatients undergoing ERCP and subsequent discharge. Furthermore, little is known with regard to fluid type, volume, and timing with respect to ERCP. In this study, we will aim to assess whether the amount of peri-procedural intravenous fluid administered around the time of ERCP is associated with the risk of PEP (the primary outcome).
详细描述
- Background and Rationale
While very effective, endoscopic retrograde cholangiopancreatography (ERCP) is widely known to have the highest adverse event (AE) profile among all commonly performed endoscopic procedures, with a collective AE rate of >10%. Common AEs include post-ERCP pancreatitis (PEP), bleeding, cholangitis, cholecystitis, perforation, and cardiopulmonary events. PEP is the most common, with estimated rates of 5-10%. It is noteworthy that both the incidence of PEP and its associated mortality are rising.
It is of critical priority to patients, practitioners, and health administrators to investigate factors associated with all AEs and unplanned healthcare encounters (UHEs) following ERCP, especially given that most ERCPs are performed on an outpatient basis. The per-admission costs of post-ERCP UHEs are substantial, exceeding $10,000 and $70,000 for pancreatitis and cholangitis, respectively. PEP alone accounts for an estimated $200+ million in annual healthcare spending in the United States. Thus, researchers must prioritize the study of ERCP outcomes, striving to both identify and modify factors leading to AEs and UHEs.
Peri-procedural fluid management and its relationship with ERCP outcomes also remains incompletely understood. Aggressive intravenous hydration (AH) has been shown to reduce the risk of PEP compared with standard peri-procedural hydration regimens. However, all AH regimens studied to date involve continuous hydration for 8-24 hours, which is impractical and thus non-generalizable to almost all North American outpatient ERCPs practices. To date, no studies have prospectively assessed short-term (60-90 minute) aggressive hydration regimens that are feasible for outpatients undergoing ERCP and subsequent discharge. Furthermore, little is known with regard to fluid type, volume, and timing with respect to ERCP. 2. Research Question and Objectives
In this study, we will aim to assess whether the amount of peri-procedural intravenous fluid administered around the time of ERCP is associated with the risk of PEP (the primary outcome). 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, regardless of indication;
- •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.
结局指标
主要结局
post-ERCP pancreatitis
时间窗: 30 days
Number of participants with any 2 of: (1) epigastric abdominal pain, (2) serum amylase/lipase \>3x the upper limit of normal, (3) imaging findings consistent with acute pancreatitis
次要结局
未报告次要终点