Diclofenac for the Prevention of Post-ERCP Pancreatitis in Higher Risk Patients: A Prospective, Randomized, Double Blind, Placebo Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- post-ercp pancreatitis
研究概览
简要总结
Inflammation of the pancreas (pancreatitis) is an uncommon but potentially serious complication of endoscopic retrograde cholangiopancreatography (ERCP), a specialized endoscopic examination of the ducts draining the liver and pancreas. Although many different strategies have been tried and studied in attempts to reduce this risk, few have been shown to make a significant difference. Those that have are either very expensive, difficult to administer, or both.
Diclofenac, an anti-inflammatory medication most often used to treat arthritis, has shown potential to decrease the risk of post-ERCP pancreatitis. It can be given after the procedure to patients at most risk for the complication, and has few side effects. This study will randomize people in the study to placebo or active medication, to determine if Diclofenac reduces the incidence of pancreatitis.
详细描述
Hypothesis:
Diclofenac, when administered immediately post ERCP in patients at higher risk of developing post-ERCP pancreatitis, will significantly reduce the incidence of this complication.
Intervention:
All patients undergoing ERCP not having exclusion criteria will be approached for participation prior to the procedure. At the end of the procedure, prior to transfer from the endoscopy suite, within 15 minutes of the end of the procedure, if the patient meets inclusion criteria, a study suppository will be administered.
The suppositories will be prepared by a study pharmacist according to a randomization list prepared by an independent biostatistician. They will be randomized using a permuted block design, in blocks of 20. The placebo is inert, and identical to the study medication, a 100 mg diclofenac rectal suppository. The code will not be broken until enrolment of patients is complete.
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
- 否
入选标准
- •These were chosen based on a review of the major studies evaluating risk factors for post-ERCP pancreatitis. Any of the following factors placing a patient at high risk (>10%) of post ERCP pancreatitis:
- •Patient characteristics: Prior history of post-ERCP pancreatitis, prior history of acute pancreatitis, suspected Sphincter of Oddi dysfunction, or normal bilirubin;
- •Procedure related factors: Moderate (6-15 attempts) and difficult (>15 attempts) bile duct cannulation, balloon dilation of the biliary sphincter, pre-cut papillotomy, pancreatic sphincterotomy.
排除标准
- •Ongoing acute or chronic pancreatitis;
- •Previous biliary sphincterotomy;
- •Contra-indications to non-steroidal anti-inflammatory medications (allergy, reduced renal function, recent upper gastrointestinal bleeding);
- •Ingestion of an NSAID ( nonsteroidal anti-inflammatory drug) in the previous 7 days.
研究组 & 干预措施
placebo suppository
干预措施: placebo (Drug)
diclofenac suppository
干预措施: diclofenac (Drug)
结局指标
主要结局
post-ercp pancreatitis
时间窗: 24 hours
次要结局
- severity of pancreatitis, side effects(30 days)
研究者
Dr. Lawrence Hookey
Principal Investigator
Queen's University