Does Glyceryl Nitrate Prevent Post-Endoscopic Retrograde Cholangiopancreaticography (ERCP) Pancreatitis?
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,600
- 试验地点
- 24
- 主要终点
- acute pancreatitis within 7 days after the ERCP procedure. (An independent committee at each center will retrospectively judge whether patients have had post-ERCP pancreatitis or not in respect to a specific definition.)
研究概览
简要总结
Post-ERCP pancreatitis can be a serious complication to ERCP. Two studies have shown a promising preventive effect of glyceryl nitrate. This study should provide a final answer to the clinical question: Does glyceryl nitrate prevent post-ERCP pancreatitis? The study is a prospective, randomized, double blind, placebo-controlled multicenter trial. The investigators intend to include 1600 patients from Norway, Sweden, Denmark, and France.
The patients will receive either placebo or a glyceryl nitrate patch (15 mg/24 hours). Follow-up will occur after 7 days. The primary outcome measure will be post-ERCP pancreatitis, and secondary outcome measures will be mild, moderate and severe pancreatitis; post procedure pancreatitis-related mortality; and adverse events.
详细描述
Project:
This study will compare glyceryl nitrate (GN) treatment to non-active treatment for the prevention of post-ERCP acute pancreatitis, which is an inflammation of the pancreas that can occur after a procedure known as ERCP.
Background:
ERCP (endoscopic retrograde cholangiopancreaticography) is an examination of the pancreas by which it is possible to perform therapeutic measures such as stone removal from the common bile duct and visualisation of the pancreas. Inflammation of the pancreas after the ERCP procedure (called: post-ERCP pancreatitis) is the most feared and common complication of the ERCP. It occurs in 1-40% of patients, with rates of 5% or more being more typical. Currently, the background of post-ERCP pancreatitis is poorly known.
Attempts at preventing post-ERCP pancreatitis have been carried out through a change to low-risk techniques, by avoiding high-risk patients, and by use of pharmacological prophylaxis.
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
- Double
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
- •All patients (men and women) more than 18 years old who are going to have an ERCP procedure performed at the different centers from September 1, 2004 to about January 31, 2005 will be included.
排除标准
- •Before the study: active acute pancreatitis (defined as: acute upper abdominal pain and S-amylases x 3 upper normal limit OR upper abdominal pain + radiological findings [CAT-/MR-scan] consistent with acute pancreatitis OR pathoanatomical findings consistent with acute pancreatitis by surgery)
- •Known previous sphincterotomy
- •Chronic pancreatitis with known calcifications
- •Hypotension (definition: systolic blood pressure < 100 mmHg)
- •Anemia, men/women (hemoglobin < 6 mmol/l or <9.7 g/dl)
- •Constrictive pericarditis
- •Pericardial tamponade
- •Hypertrophic obstructive cardiomyopathy, aortic stenosis
- •Mitral stenosis sildenafil within 24 hours before the ERCP procedure and 24 hours after the procedure
- •Hypersensibility to nitroglycerine
- •Hypersensibility to the applied glue on the patch
- •Known untreated hypothyroidism
- •Pregnancy or a potential to become pregnant, i.e. those who are not using safe contraception (intrauterine device [IUD] or oral contraception)
- •Included earlier in the study
- •Exchange of stent
结局指标
主要结局
acute pancreatitis within 7 days after the ERCP procedure. (An independent committee at each center will retrospectively judge whether patients have had post-ERCP pancreatitis or not in respect to a specific definition.)
次要结局
- post procedure pancreatitis-related mortality
- mild, moderate, and severe pancreatitis as a criterion proposed by Cotton et al [12]
- adverse events (severe and non-severe such as headache, dizziness, hypotension, hypersensibility, and others)