Prevention of Post-ERCP Acute Pancreatitis by Heme-oxygenase Activation Through the Administration of Hemin : a Prospective, Randomized Double Blind Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 284
- 试验地点
- 6
- 主要终点
- Incidence of post-ERCP acute pancreatitis
研究概览
简要总结
ERCP (endoscopic retrograde cholangiopancreatography) has been largely demonstrated to be effective in multiple bilio-pancreatic indications. However, one of the feared complication of this technique is acute pancreatitis, which happens in 5 to 25% of cases. Some patient groups have been demonstrated to present a higher risk linked to individual factors or to the procedure. Some interventions (endoscopic or pharmacologic) have been evaluated to reduce the incidence of this complication but each has his own inconvenient. Recently, the activation of heme oxygenase (HO) by intraperitoneal administration of hemin has been demonstrated to be effective in prevention and treatment of acute pancreatitis mice models. This protective effect has been associated to intrapancreatic HO-1 positive macrophage recruitment activated by hemin. The investigators thus propose to conduct a prospective randomized double blind controlled trial to demonstrate a protective effect of hemin administration against post-ERCP acute pancreatitis in high risk patients.
详细描述
Patients for who a pancreatic stent placement is indicated will be excluded from the study.
The aims of this study are: 1) to study in a pathophysiologic point of view the activation of HO-1 by hemin in human and its protective effect in post-ERCP acute pancreatitis incidence. 2) to use the human situation of post-ERCP acute pancreatitis as early pancreatitis model to study the administration of hemin as treatment of acute pancreatitis in general.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •one or more factors of >10% post-ERCP acute pancreatitis risk:
- •former episode of acute pancreatitis
- •former episode of post-ERCP acute pancreatitis
- •normal bilirubin level
- •main pancreatic duct injection
- •endoscopic biliary sphincteroplasty (balloon dilation of biliary sphincter)
- •precut papillotomy
- •pancreatic sphincterotomy
排除标准
- •patient for whom a pancreatic stent is inserted (Sphincter of Oddi dysfunction, ampullectomy)
- •ongoing acute pancreatitis
- •chronic pancreatitis (Cremer classification >=2)
- •age < 18 y/o
- •pregnancy
- •hemin allergy
- •severe renal failure (MDRD<30ml/min/1.73m2)
研究组 & 干预措施
Hemin
A peripheral perfusion of 4mg/kg of hemin (Normosang) diluted in 100mL NaCL (sodium chloride) 0.9% will be administered in 30-60minutes as soon as possible after the end of the ERCP, followed by 100mL of NacL 0.9% to flush the vein
干预措施: Hemin (Drug)
Placebo
The same amount of NaCl 0.9% (100 ML followed by a flushing perfusion of 100mL) will be perfused to the patient as soon as possible after the end of the ERCP
干预措施: placebo (Drug)
结局指标
主要结局
Incidence of post-ERCP acute pancreatitis
时间窗: at day 1 post-ERCP
Post-ERCP acute pancreatitis is defined by an abdominal pain compatible with pancreatitis and the elevation of seric lipases more than 3 times the upper limit of normal on days 1 post-ERCP.
次要结局
- length of stay(during the hospitalization (up to 2 months))
- safety of hemin administration(within 7 days)
- severity of post-ERCP acute pancreatitis(during the hospital stay (up to 2 months))
研究者
Lemmers Arnaud
MD, PhD
Erasme University Hospital