Dose-escalation of Rectal Indomethacin for Post-ERCP Pancreatitis Prevention in High-risk Patients: Protocol of a Multicentre Randomised Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 1,036
- 试验地点
- 1
- 主要终点
- the incidence and severity of PEP
研究概览
简要总结
Our aim is to compare the efficacy of 100 mg versus 200 mg rectal indometacin in preventing post-ERCP pancreatitis (PEP) among high-risk patients without no pancreatic stenting. The 100 mg versus 200 mg indometacin trial is a multicentre, single-blind, randomized controlled study. High-risk patients for PEP without pancreatic stent insertion will be informed about the opportunity to participate. A total of 1,036 eligible patients will be randomly assigned in a 1:1 ratio to one of two groups: (1) administration of 100 mg rectal indometacin immediately after ERCP (standard-dose group), or (2) administration of 200 mg rectal indometacin immediately after ERCP (high-dose group). The primary outcome is the incidence and severity of PEP. Secondary outcomes include hyperamylasemia and other ERCP-related adverse events (AEs).
详细描述
Evidence suggests that escalating the rectal indometacin dose to 200 mg offers no clear advantage over the standard 100 mg regimen in high-risk patients. However, the majority of participants (76%) had received pancreatic stent placement, raising the possibility that the benefit of the supplementary strategy may have been obscured by the considerable efficacy of pancreatic stenting. Our aim is to compare the efficacy of 100 mg versus 200 mg rectal indometacin in preventing post-ERCP pancreatitis (PEP) among high-risk patients without no pancreatic stenting.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
For enhanced objectivity in data analysis, the project statisticians will be blinded to the arm allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants will be eligible for enrollment if they meet all of the following criteria:
- •age over 18 years;
- •classified as high risk for post-ERCP pancreatitis;
- •provision of signed, written informed consent.
排除标准
- •Participants will be excluded if they meet any of the following conditions:
- •inaccessible major papilla;
- •surgically altered gastrointestinal anatomy;
- •current diagnosis of acute pancreatitis;
- •placement of a pancreatic stent;
- •contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs), including known allergy, renal insufficiency, or active peptic ulcer disease;
- •anticipated low risk of post-ERCP pancreatitis (e.g., patients with chronic calcific pancreatitis, pancreatic head mass, or those undergoing biliary interventions through a pre-existing sphincterotomy); 7.severe active cardiopulmonary disease;
- •pregnancy or breastfeeding;
- •presence of an ampullary tumor.
研究组 & 干预措施
standard-dose group
administration of 100 mg rectal indometacin immediately after ERCP
干预措施: standard-dose group VS high-dose group (Drug)
high-dose group
administration of 200 mg rectal indometacin immediately after ERCP
干预措施: standard-dose group VS high-dose group (Drug)
结局指标
主要结局
the incidence and severity of PEP
时间窗: up to 1 months
Patients were identified as post-ERCPpancreatitis if meeting two out of three criteria: pain consistent with acute pancreatitis; amylase or lipase\>3 times normal limit; characteristic findings on imaging, in according to the Revised Atlanta International consensus.
次要结局
未报告次要终点