Impact of Pinaverium Bromide on Bile Duct and Pancreatic Duct Cannulation During Endoscopic Retrograde Cholangiopancreatography
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- cannulation time for deep bile duct cannulation and pancreatic duct cannulation
研究概览
简要总结
Pinaverium bromide can be used to treat symptoms related to irritable bowel syndrome (IBS) and functional disorders of the biliary tract. In this study, pinaverium bromide was compared with Vitamin C for the facilitation of bile duct and pancreatic duct cannulation in patients. The primary outcome was successful deep bile duct cannulation and pancreatic duct canulation. The second outcome was the major papillary orifice,bile juice flow from the papilla, time to achieve deep bile duct cannulation, fluoroscopy time for deep bile duct cannulation,the appearance of the major and minor papillary orifice, pancreatic juice flow from the papilla, time to achieve deep pancreatic duct cannulation, and fluoroscopy time for deep pancreatic duct cannulation in the pinaverium bromide group versus Vitamin C group.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •those with intact native papilla,
- •who underwent endoscopic retrograde choledochopancreatography for bile duct,
- •age≥18 years, ≤80years, and
- •agreement to participate in the study.
排除标准
- •a previous sphincterotomy,
- •previous attempted or unsuccessful endoscopic retrograde choledochopancreatography with papillary manipulation,
- •indwelling biliary or pancreatic stent(s),
- •active acute pancreatitis,
- •active acute pancreatitis
- •altered/postsurgical anatomy,
- •history of gastroparesis,
- •endoscopic retrograde choledochopancreatography for sphincter of Oddi's sphincter(SO) manometry,
- •known tumor of the major duodenal papilla, and
- •patients with any medication probably affecting SO motility
结局指标
主要结局
cannulation time for deep bile duct cannulation and pancreatic duct cannulation
时间窗: 2 days
次要结局
- appearance of the major papillary orifice(2 days)
- bile juice flow from the major papilla and pancreatic juice flow from the major papilla(2 days)
研究者
Zhaoshen Li
Head of Digestive Endoscopy Center
Changhai Hospital