Prevention of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) - Induced Pancreatitis Using Aggressive Lactated Ringer's Infusion and/or Rectal Indomethacin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- The Number of Participants With Acute Pancreatitis After ERCP as Assessed by Worsening Abdominal Pain Plus Either Elevated Amylase or Lipase 3 x Upper Limit of Normal
研究概览
简要总结
Post-ERCP pancreatitis is a well-known and sometimes life-threatening complication of ERCP. Both LR and rectal indomethacin have shown benefit in preventing post-ERCP pancreatitis. Despite this, no study to date has evaluated both of these measures for preventing post-ERCP pancreatitis. It is our hope to evaluate the combination of these two modalities for preventing post-ERCP pancreatitis compared with either modality alone.
详细描述
Endoscopic retrograde cholangiopancreatography (ERCP) is commonly used diagnostic and therapeutic intervention used in Gastroenterology. At Cooper University Hospital (CUH), we perform approximately 700 ERCPs per year. A known complication of ERCP is post-ERCP pancreatitis. The incidence of post-ERCP pancreatitis has been cited at anywhere from 2.6-3.5% of cases. Also, severe acute pancreatitis has been cited at rates of 0.32-0.4% and death 0.11%.
Recent literature has cited the use of several modalities useful in preventing post-ERCP pancreatitis. Among the modalities evaluated non-steroidal anti-inflammatory drugs (NSAIDS), specifically rectal indomethacin, have demonstrated benefit in preventing post-ERCP. In particular Elmunzer et al demonstrated a benefit in those with sphincter of oddi dysfunction (SOD) and those deemed "high risk" for post-ERCP pancreatitis. Other medication such at octreotoide and corticosteroid have shown mixed results.
Additionally, recent studies have demonstrated the use of lactated ringer's solution (LR) in lieu of normal saline (NS) in patient's with acute pancreatitis. Due to this thought process a recent study evaluated the use of LR in preventing post-ERCP pancreatitis. The results of this study showed that no patients who received aggressive LR hydration developed post-ERCP pancreatitis.
As rectal indomethacin and LR infusion appear to have the most definitive evidence for preventing post-ERCP pancreatitis, it is our hope to evaluate the combination of these two therapies for the prevention of post-ERCP pancreatitis.
This is a double blinded, randomized prospective cohort study involving 4 treatment groups undergoing ERCP.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- 是
入选标准
- •1 Subjects who are undergoing endoscopic retrograde cholangiopancreatography (ERCP)
- •Age > 18 years
- •Non-pregnant
- •Non-prisoners
- •Subjects who can sign informed consent
- •Serum Creatinine < 1.2 milligrams/deciliter (mg/dL)
- •Subjects without renal failure (acute or chronic)
- •Subjects without congestive heart failure (ejection fraction < 40%)
- •Subjects without cirrhosis of the liver
- •Subjects without allergy to aspirin or non-steroidal anti-inflammatory drugs (NSAIDS)
- •Subjects not on non-steroidal anti-inflammatory drugs NSAIDS prior to enrollment
排除标准
- •Subjects who are not undergoing ERCP
- •Age < 18 years
- •Pregnancy
- •Prisoners
- •Subjects lacking the capacity to consent for themselves
- •Serum Creatinine > 1.2 milligrams/deciliter (mg/dL)
- •Subjects with renal failure (acute and chronic)
- •Subjects with congestive heart failure (ejection fraction < 40%)
- •Subjects with cirrhosis of the liver
- •Subjects with allergy to aspirin or non-steroidal anti-inflammatory drugs (NSAIDS)
- •Subjects with gastrointestinal hemorrhage
- •Subjects on chronic non-steroidal anti-inflammatory drugs NSAIDS
- •Subjects with acute pancreatitis the day of their procedure (CITE 1-3)(APPENDIX 1)
研究组 & 干预措施
A (NS+Placebo)
Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure )
干预措施: Normal Saline (Drug)
A (NS+Placebo)
Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure )
干预措施: Placebo (Drug)
B (NS+IND)
Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure )
干预措施: Indomethacin (Drug)
B (NS+IND)
Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure )
干预措施: Normal Saline (Drug)
C (LR+Placebo)
Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure)
干预措施: Lactated Ringer's Solution (Drug)
C (LR+Placebo)
Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure)
干预措施: Placebo (Drug)
D (LR+IND)
Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure)
干预措施: Indomethacin (Drug)
D (LR+IND)
Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure)
干预措施: Lactated Ringer's Solution (Drug)
结局指标
主要结局
The Number of Participants With Acute Pancreatitis After ERCP as Assessed by Worsening Abdominal Pain Plus Either Elevated Amylase or Lipase 3 x Upper Limit of Normal
时间窗: 30 days after ERCP
amylase or lipase
The Number of Participants With Acute Pancreatitis After ERCP as Assessed by Worsening Abdominal Pain Plus Imaging Suggestive of Acute Pancreatitis
时间窗: 30 days after ERCP
Imaging may include Computer Tomography
次要结局
- The Number of Participants With Acute Respiratory Distress Syndrome (ARDS) After ERCP as Assessed by ARDSnet Criterion (Below)(30 days after ERCP)
- The Length of Stay (LOS) of Participants After ERCP if Medical Care is Sought as Assessed in Days(30 days after ERCP)
- The Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) After ERCP as Assessed by the SIRS Criterion (Below)(30 days after ERCP)
- The Number of Participants With Pancreatic Pseudocyst After ERCP as Assessed by Abdominal Imaging Suggestive of Pseudocyst(30 days after ERCP)
- The Number of Participants With Sepsis After ERCP as Assessed by Infectious Source Defined by Positive Microbiology Culture(30 days after ERCP)
- The Number of Participants With Multiple Organ Failure (MOF) After ERCP as Assessed by Elevated Creatinine Blood Test(30 days after ERCP)
- The Number of Participants With Multiple Organ Failure (MOF) After ERCP as Assessed by Elevated International Normalized Ratio (INR)(30 days after ERCP)
- The Number of Participants With Pancreatic Abscess After ERCP as Assessed by Abdominal Imaging Suggestive of Pancreatic Abscess(30 days after ERCP)
- The Number of Participants With Perforation After ERCP as Assessed by Abdominal Imaging Suggestive of Perforation(30 days after ERCP)
- The Number of Participants Who Undergo Surgery After ERCP, as Assessed by Surgical Operative Report(30 days after ERCP)
- The Number of Participants With Mortality After ERCP as Assessed by Medical Record Reporting(30 days after ERCP)
- The Number of Participants With Post-procedural Medical Care (ED Visit, Urgent Care, Hospitalization) as Assessed by Medical Record and Patients Self-reporting(30 days after ERCP)
- The Number of Participants Who Were Readmitted After ERCP as Assessed by Medical Record and Patients Self-reporting(30 days after ERCP)
研究者
Shaffer R S Mok
Clinical Instructor
The Cooper Health System