Randomized Trial of Rectal Indomethacin to Prevent Acute Pancreatitis in Patients Undergoing Endoscopic Ultrasound-guided Fine Needle Aspiration of Pancreatic Cysts
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Rate of post-procedure pancreatitis following EUS-guided fine needle aspiration of pancreatic cysts
研究概览
简要总结
The aim of this randomized trial is to compare the rate of post-procedure pancreatitis in patients undergoing EUS-FNA of pancreatic cysts; patients will receive either a single dose of indomethacin or placebo administered rectally, during EUS-FNA.
详细描述
Pancreatic cysts are pre-malignant lesions and are being increasingly diagnosed on cross-sectional imaging. Endoscopic ultrasound (EUS) is performed to further evaluate pancreatic cysts, and fine needle aspiration (FNA) is conducted to obtain a sample of the cystic fluid for analysis and examination for malignant cells. Acute pancreatitis is a complication of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of pancreatic cysts, which can lead to significant morbidity and substantial health care costs. The aim of this randomized trial is to compare the rate of post-procedure pancreatitis in patients undergoing EUS-FNA of pancreatic cysts; patients will receive either a single dose of indomethacin or placebo administered rectally, during EUS-FNA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Age ≥ 18 years
- •Suspected or confirmed pancreatic cyst seen on imaging, requiring EUS-FNA
排除标准
- •Unable to obtain consent from the participant or the participant's legally authorized representative (LAR)
- •Intrauterine pregnancy
- •Hypersensitivity reaction to Aspirin or NSAIDs
- •Patients with known history of chronic pancreatitis
- •Patients with known renal failure
结局指标
主要结局
Rate of post-procedure pancreatitis following EUS-guided fine needle aspiration of pancreatic cysts
时间窗: 30 days
Post-procedure pancreatitis is defined as the development of new or increased abdominal pain consistent with acute pancreatitis, and elevated amylase or lipase at least three times the upper limit of normal .
次要结局
- Rate of procedure-related adverse events(30 days)
- Disease-related adverse events(30 days)
- Rate of mild, moderate and severe pancreatitis post-FNA(30 days)
- Length of hospitalization in any patient hospitalized with any adverse event(30 days)
- Length of hospitalization in any patient hospitalized with acute pancreatitis(30 days)