Inadvertent Pancreatic Duct Cannulation as an Independent Predictor of Post- Endoscopic Retrograde Cholangiopancreatography Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7,461
- 试验地点
- 1
- 主要终点
- post-ERCP pancreatitis
研究概览
简要总结
Intra-procedural guidewire management is a parameter whose impact remains incompletely understood in terms of its association with post- endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). Inadvertent guidewire cannulation of the pancreatic duct (PD) when attempting common bile duct (CBD) cannulation is recognized as a risk factor for PEP. However, to date, no studies have assessed whether a single PD wire cannulation is associated with a higher PEP risk compared to no PD cannulations. Similarly, the relationship between each additional PD cannulation and the incremental magnitude of PEP risk remains unclear. In this study, the investigators will aim to assess whether a single inadvertent PD cannulation (versus no PD cannulation) is associated with an increased 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.
Intra-procedural guidewire management is a parameter whose impact remains incompletely understood. Inadvertent guidewire cannulation of the pancreatic duct (PD) when attempting common bile duct (CBD) cannulation is recognized as a risk factor for PEP. However, as inadvertent PD cannulation is highly correlated with difficult CBD cannulation in general, which itself is a risk factor for PEP, these associations are difficult to separate, even in randomized trials. To date, no studies have assessed whether a single PD wire cannulation is associated with a higher PEP risk compared to no PD cannulations. Similarly, the relationship between each additional PD cannulation and the incremental magnitude of PEP risk remains unclear. 2. Research Question and Objectives
In this study, the investigators will aim to assess whether a single inadvertent PD cannulation (versus no PD cannulation) is associated with an increased 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
- •Previous sphincterotomy or sphincteroplasty
- •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
Defined using a previously published set of a priori criteria by indication (Cotton et al. Gastrointest Endoscopy 2010; 71:446-54).
次要结局
未报告次要终点