Randomized Trial Examining the Impact of Pancreatic Duct Stent Placement in Patients With Acute Necrotizing Pancreatitis in the Prevention of Walled-off Necrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AdventHealth
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Incidence of WON between the PD stent and no PD stent groups
研究概览
简要总结
The research design is a randomized prospective clinical study comparing the incidence of Walled Off Necrosis (WON) in patients with acute necrotizing pancreatitis.
详细描述
This is a randomized trial comparing the incidence of WON in patients with acute necrotizing pancreatitis, according to the placement or non-placement of an Advanix or a Cook Pancreatic Duct (PD) stent during Endoscopic Retrograde Cholangiopancreatography (ERCP) within 1-2 week of symptom onset. Patients will be randomly allocated to either treatment arm i.e. to either PD stent placement or no PD placement in a 1:1 ratio. The type of stent to be placed is at the discretion of the physician based on the clinical needs and presentation of the patient at the time of procedure. This is based on factors such as the size of the WON, the patient's anatomy, and other variables. Patients will be assessed at 4-6 weeks post-ERCP for the primary outcome measure, which is the incidence of WON on contrast-enhanced CT.
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
- Single (Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 19 years
- •The subject (or when applicable the subject's LAR) is capable of understanding and complying with protocol requirements.
- •The subject (or when applicable the subject's LAR) is able to understand and willing to sign an informed consent form prior to the initiation of any study procedures.
- •All patients with acute necrotizing pancreatitis and bedside index for severity in acute pancreatitis (BISAP) score of ≥ 3, who have been referred to Florida Hospital for Percutaneous endoscopy gastrojeunostomy (PEG-J) tube placement and/or ERCP for assessment of the PD
- •Absence of pancreatic fluid collection (defined as those > 3cm in size located along the course of the main PD on cross-sectional imaging) at the time of study enrollment
- •No disconnected pancreatic duct syndrome (DPDS) on cross-sectional imaging or ERCP
排除标准
- •Age <19 years
- •Unable to obtain consent for the procedure from either the patient or LAR
- •Patients with acute interstitial pancreatitis, without pancreatic necrosis
- •Patients with BISAP score ≤ 2
- •Patients with pancreatic fluid collection > 3cm in size located along the course of the main PD on cross-sectional imaging prior to the initial ERCP
- •Patients with DPDS on cross-sectional imaging or ERCP
- •Unable to safely undergo ERCP for any reason
- •Failed cannulation during ERCP
结局指标
主要结局
Incidence of WON between the PD stent and no PD stent groups
时间窗: 4-6 weeks post-index ERCP
The primary aim of the study is to compare the incidence of WON between the PD stent and no PD stent groups at 4-6 weeks post-index ERCP.
次要结局
- Rates of WON Intervention(6 weeks)
- Rates of DPDS(6 weeks)
- Number of patients with Adverse events(6 weeks)
- Number of patients with Local complications(6 weeks)
- Number of patients with Systemic complications(6 weeks)
- Length of stay(6 weeks)
- Cost(6 weeks)
- Rates of additional interventions resulting from complications(6 weeks)
- Number of patients with Acute pancreatitis(6 weeks)