Post ERCP Pancreatitis Prophylaxis, Effectiveness of Rectal Indomethacin vs Intravenous Ketorolac in the Pediatric Population
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Post-ERCP Pancreatitis
研究概览
简要总结
Endoscopic retrograde cholangiopancreatography (ERCP) is an essential procedure that can be complicated by post-ERCP pancreatitis (PEP). Indomethacin and ketorolac are two medications used to prevent PEP. The main reason for this research study is to compare the effectiveness these drugs at reducing rates of PEP. There have been no studies comparing the effectiveness of these medications in preventing PEP in pediatric patients. You are being asked to take part in this research study because you are scheduled to have an ERCP as part of your medical care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Months 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient undergoing ERCP (diagnostic or therapeutic with cannulation of the major or minor papilla)
- •Age 6 month- 21 years old
- •Does not meet
排除标准
- •Exclusion Criteria:
- •Low risk subgroup: Biliary indication with history of prior biliary sphincterotomy.
- •High risk for bleeding (Example: Planned liver biopsy)
- •Gastrointestinal bleeding in previous 3 days
- •Acute pancreatitis (within 3 days) at the time of ERCP
- •Use of NSAIDs in the previous 5 days
- •Peptic ulcer disease
- •Acute kidney Injury or Known Chronic Kidney Disease per KDIGO
- •Pregnancy (Pregnancy tests are administered prior to ERCP as standard of care)
- •Lithium therapy
- •Allergy to ketorolac or indomethacin
- •Organ Dysfunction or SIRS
研究组 & 干预措施
Rectal indomethacin
Dosage based on subject's weight:
>=50 kg, 100 mg; 30-49 kg, 50 mg; 10-29 kg, 25 mg
干预措施: Rectal indomethacin (Drug)
IV ketorolac
Dosage based on subject's weight: 0.5 mg/kg (maximum: 15 mg)
干预措施: IV ketorolac (Drug)
结局指标
主要结局
Post-ERCP Pancreatitis
时间窗: 2 weeks
Below is the number of participants within the rectal indomethacin and IV ketorolac cohorts who developed Post-ERCP Pancreatitis- Post ERCP Pancreatitis: A patient must have at least 2 of the following to establish a diagnosis of post ERCP pancreatitis: 1. Characteristic physical exam findings- pain worse than admission per pain scales (please see point 2) and/or nausea 2. Amylase (unit/L) or lipase(unit/L) greater than 3 times the age appropriate upper limit of normal. * Normal range of amylase (15-127 unit/L) * Normal range of lipase (12-50 unit/L) 3. Confirmatory imaging (Ultrasound, CT or MRI) that suggests or demonstrates pancreatic inflammation
Post-ERCP Pancreatitis: Pancreatic Duct Injections
时间窗: 2 weeks
86 participants from the rectal indomethacin cohort and 83 from IV ketorolac received pancreatic duct injections during their ERCP. Below we describe the outcome measure of post-ERCP pancreatitis vs. no pancreatitis for those who received pancreatic duct injections.
Post-ERCP Pancreatitis: Native Papilla
时间窗: 2 weeks
36 participants from the rectal indomethacin cohort and 33 from IV ketorolac had a native papilla for their ERCP. Below we describe the outcome measure of post-ERCP pancreatitis vs. no pancreatitis for those who had a native papilla.
Post-ERCP Pancreatitis: Pancreatic Sphincterotomy
时间窗: 2 weeks
25 participants from the rectal indomethacin cohort and 19 from IV ketorolac received pancreatic sphincterotomies during their ERCP. Below we describe the outcome measure of post-ERCP pancreatitis vs. no pancreatitis for those who received pancreatic sphincterotomies.
Post-ERCP Pancreatitis: Opti-Ray Amount
时间窗: 2 weeks
83 participants from the rectal indomethacin cohort and 84 from IV ketorolac received various amounts of Opti-Ray during their ERCP. Below we describe the outcome measure of post-ERCP pancreatitis vs. no pancreatitis for those who received Opti-Ray.
Post-ERCP Pancreatitis: Therapeutic Pancreatic Duct Stent Placed
时间窗: 2 weeks
51 participants from the rectal indomethacin cohort and 53 from IV ketorolac received a therapeutic pancreatic duct stent during their ERCP. Below we describe the outcome measure of post-ERCP pancreatitis vs. no pancreatitis for those who received therapeutic pancreatic duct stents.
Post-ERCP Pancreatitis: Prophylactic Pancreatic Duct Stent Placed
时间窗: 2 weeks
11 participants from the rectal indomethacin cohort and 11 from IV ketorolac received a prophylactic pancreatic duct stent during their ERCP. Below we describe the outcome measure of post-ERCP pancreatitis vs. no pancreatitis for those who received prophylactic pancreatic duct stents.
次要结局
- Pain Assessed by FLACC or NRS Scoring Post ERCP: PACU(2 weeks)
- Pain Assessed by FLACC or NRS Scoring Post ERCP: Evening(2 weeks)
- Pain Assessed by FLACC or NRS Scoring Post ERCP: Morning(2 weeks)
- Laboratory Markers Associated With PEP ( Lipase)(2 weeks)
- Laboratory Markers Associated With PEP (Amylase)(2 weeks)
- Length of Stay(2 weeks)
- Severity of Pancreatitis (Mild, Moderately Severe, Severe)(2 weeks)
研究者
David Vitale MD
Assistant Professor
Children's Hospital Medical Center, Cincinnati