A Prospective, Open Label Randomized Controlled Trial of Prophylactic Rectal Indomethacin Versus Combined Pancreatic Duct Stent Placement and Rectal Indomethacin for Prevention of Post-ERCP Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 384
- 试验地点
- 2
- 主要终点
- To compare rectal indomethacin alone versus combined pancreatic duct stent and rectal indomethacin in prevention of post ERCP pancreatitis
研究概览
简要总结
The goal of this clinical trial is to compare rectal indomethacin alone versus combined pancreatic duct stenting and rectal indomethacin in prevention of post ERCP pancreatitis. The main question it aims to answer is: whether rectal indomethacin alone is superior to combination of pancreatic duct stenting and rectal indomethacin in prevention of post ERCP pancreatitis Participants will be patients who give consent to the study and who are required to undergo ERCP as part of their standard care.
If there is a comparison group: Researchers will compare [rectal indomethacin alone versus combined pancreatic duct stenting and rectal indomethacin in prevention of post ERCP pancreatitis.] to see if [whether rectal indomethacin alone is superior to combination of pancreatic duct stenting and rectal indomethacin in prevention of post ERCP pancreatitis].
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected sphincter of Oddi dysfunction
- •History of post ERCP Pancreatitis
- •Pancreatic instrumentation or sphincterotomy.
- •Precut sphincteroyomy
- •Difficult cannulation defined by more than 5 cannulation attempts
- •The use of double wire technique in bile duct access
- •At least 2 of the followings including
- •Female age < 50 year
- •3 pancreatogram
- •Acinarization (Contrast injection to tail of pancreas
- •Normal serum bilirubin
- •Guidewire to the tail of pancreas or secondary branches
排除标准
- •Patient planned for pancreatic stenting
- •Without informed consent
- •Age < 18 years
- •Pregnant women
- •Lactating women
- •Patient with altered anatomy
- •Contraindications to the use of NSAIDS
- •Renal failure
- •Ongoing or recent hospitalisation for acute pancreatitis
- •Allergy to aspirin or NSAIDs
- •known chronic calcific pancreatitis -
研究组 & 干预措施
Rectal indomethacin
干预措施: Rectal Indomethacin (Drug)
Pancreatic duct stent and rectal indomethacin
干预措施: Prophylactic Pancreatic duct stenting (Procedure)
结局指标
主要结局
To compare rectal indomethacin alone versus combined pancreatic duct stent and rectal indomethacin in prevention of post ERCP pancreatitis
时间窗: 24 hour
For comparison between these two arms the investigators will measure serum amylase in U/L value after 6 hour and 24 hour of the ERCP procedure. The investigators will also assess for pain abdomen and vomiting suggestive of acute pancreatitis.
次要结局
未报告次要终点
研究者
Mukti Prakash Meher
Principal investigator
Moti Lal Nehru Medical College