Intramuscular Diclofenac vs. Placebo in a Randomized Double Blind Controlled Trial, In Post ERCP Pancreatitis.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- prevention of pancreatitis,
研究概览
简要总结
- The most common complication of endoscopic retrograde cholangio-pancreaticography (ERCP) is pancreatitis.
- Several studies showed that non-steroidal anti-inflammatory drugs (NSAIDs) can prevent the post ERCP pancreatitis, the investigators used diclofenac vs placebo.
- The effect of diclofenac in prevention of that complication, was measured by the number of patients who developed pancreatitis, and compare it with the placebo.
- The investigators collected 199 patients, 17 excluded, 182 completed the study, all of them underwent the intervention called "ERCP", and randomized to have either Diclofenac or Placebo before the procedure.
详细描述
- All patients signed informed consents for the procedure, and the participation in the study.
- Between June 2012 and June 2013, 199 patients fulfilled the inclusion criteria, 182 of whom were included in the final analysis.
- Patients were excluded from study participation if they had a contraindication for diclofenac, including patients with recently diagnosed peptic ulcer disease, renal failure, those who developed acute pancreatitis during the two weeks before ERCP, those with a history of chronic pancreatitis, and those who did not agree to participate in the study.
- A placebo-controlled trial was conducted in 182 patients who underwent ERCP.
- Preoperative, the patients received 75 mg intramuscular(IM) diclofenac or IM normal saline as placebo. At the end of each procedure, the investigators recorded the details of the maneuvers performed, including:
- the total time of the procedure,
- the number of attempts at cannulation,
- the number of pancreatic duct cannulation,
- the final diagnosis by ERCP,
- whether a sphincterotomy, a needle-knife papillotomy, or stent placement were performed.
-
Serum amylase was determined 12 hours after ERCP.
-
If the 12-hours serum amylase level was > 3 times the upper normal limit and the patient exhibited pain or nausea and vomiting, then the patient had pancreatitis.
-
Acute pancreatitis was defined as serum amylase > 3 times the upper limit of normal and associated with epigastric pain, back pain, and epigastric tenderness.
-
Statistical analysis:
- Randomization was done by the GI nurse, concealed envelop
- Data were summarized by descriptive statistics.
- The Chi square was used to compare categorical patient data.
- The Student's t test was used to compare continuous variables.
- Two-tailed P < 0.05 was considered to indicate significance.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 16 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •any patient above the age of 16, referred for ERCP
排除标准
- •1.could not reach the ampulla due to: A. Pyloric stenosis B. Ampullary tumor C. Diverticula
- •ERCP done recently
- •Stent replacement
- •Congestive Heart Failure(CHF)
研究组 & 干预措施
Diclofenac,75 mg, 3 ml,
patients were given Diclofenac IM before ERCP.
干预措施: ERCP (Procedure)
Diclofenac,75 mg, 3 ml,
patients were given Diclofenac IM before ERCP.
干预措施: Diclofenac hydroxyethylpyrrolidine (Drug)
Normal Saline, 3ml, IM
patients were given normal saline 3 ml before ERCP
干预措施: ERCP (Procedure)
Normal Saline, 3ml, IM
patients were given normal saline 3 ml before ERCP
干预措施: Normal Saline (Drug)
结局指标
主要结局
prevention of pancreatitis,
时间窗: within a week after procedure
1. Patients with epigastric pain, back pain, and epigastric tenderness, 2. And all had serum amylase measured after the procedure, if elevated more than 3 folds of normal, the patient was diagnosed to have post ERCP pancreatitis,
次要结局
未报告次要终点
研究者
Yasser Abu-Safieh
Associate Prof, MD, AGAF
Specialized Arab Hospital