Prevention of Acute Pancreatitis After Endoscopic Interventions
试验速览
- 阶段
- 1 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in the level of inflammation and pain, assessment of severity according to the Ranson scale and Krasnogorov at 1 week
研究概览
简要总结
The aim of the study is to develop a method for the prevention of acute pancreatitis after minimally invasive interventions of the bile ducts using a drug regimen.
详细描述
A prospective, randomized, single-center study is planned to identify the most effective drug regimen in order to prevent the development of acute pancreatitis after transpapillary interventions of the bile ducts.
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 (Participant, Investigator)
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
- •Patients with cholangiolithiasis.
- •Patients with benign formations of the bile ducts.
- •Patients with malignant formations of the bile ducts.
- •Patients with extrahepatic bile duct cysts.
- •Patients with biliary hypertension of unknown etiology.
- •Patients with cholangitis.
- •Patients with extrahepatic bile duct strictures.
- •Patients suffering from oncopathology of the head of the pancreas, complicated by obstructive jaundice.
- •Patients with malignant pathology of the pancreas.
- •Patients with benign pancreatic pathology.
排除标准
- •ASA scale> III (severe concomitant cardiovascular pathology)
- •Severe pathology of the respiratory system.
- •Acute period of myocardial infarction.
- •Acute period of cerebral infarction.
研究组 & 干预措施
Meksibel
Intravenous 0.1 30 minutes before the procedure and 0.1 once a day for 3 days after the procedure
干预措施: Meksibel (Drug)
Indometacin
Into the rectum 1 hour before the procedure and 1 candle 1 time a day for 3 days after the procedure
干预措施: Meksibel (Drug)
Meloksicam
Intravenous 15 mg 30 minutes before the procedure and 15 mg once a day for 3 days after the procedure
干预措施: Meksibel (Drug)
Oktride
Intravenous 3 ml 30 minutes before the procedure and 3 ml once a day for 3 days after the procedure
干预措施: Meksibel (Drug)
结局指标
主要结局
Change in the level of inflammation and pain, assessment of severity according to the Ranson scale and Krasnogorov at 1 week
时间窗: 1 week
Summ points 0 - pancreatitis, 1 - mild pancreatitis, 2 - severe pancreatitis
次要结局
未报告次要终点