Early Versus Late Pancreatic Stent Placement for Preventing Post-ERCP Pancreatitis: a Multicentre, Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 768
- 试验地点
- 2
- 主要终点
- The incidence and severity of post-ERCP pancreatitis
研究概览
简要总结
Our aim is to compare early versus late pancreatic stent placement in preventing PEP among patients with naive papilla. The EVL trial will provide essential answers regarding the optimal timing of prophylactic pancreatic stent placement in PEP prevention.All patients with difficult biliary cannulation undergoing endoscopic retrograde cholangiopancreatography (ERCP) with pancreatic guidewire-assisted technique for biliary access will be told about the opportunity to participate in EVL research. In total, 768 patients will be randomly assigned (1:1) to two arms: (1) early pancreatic stent placement (EPSP) (a pancreatic stent will be placed immediately after endoscopic retrograde cholangiography (ERC) or endoscopic sphincterotomy (EST)) and (2) late pancreatic stent placement (LPSP) (a pancreatic stent will be placed after all completion of therapeutic biliary procedures, e.g. biliary stone removal or drainage).The primary outcome is the rate and severity of PEP. The secondary outcomes are hyperamylasemia, the rate of stenting success, and other ERCP-related adverse events (AEs).
详细描述
Patients with challenging biliary access using pancreatic guidewire-assisted method will be enrolled in the study. Recruitment will take place among individuals referred to the four participating centers for therapeutic biliary procedures. After obtaining signed consent forms, participants who meet all the inclusion criteria and have no exclusion criteria will be randomly grouped (with a 1:1 ratio) into EPSP and LPSP
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
- 否
入选标准
- •Participants who fulfill all the below criteria will be enrolled:
- •with naive papilla;
- •over 18 years;
- •undergoing ERCP with pancreatic guidewire-assisted technique for biliary access;
- •providing a signed, written informed consent.
排除标准
- •Participants who meet any of the following criteria will be excluded:
- •unreachable main papillae;
- •surgically altered gastrointestinal anatomy;
- •concurrent acute pancreatitis;
- •biliary cannulation over pancreatic duct stent after precut sphincterotomy or wire-guided method (native early attribute);
- •failed biliary cannulation;
- •severe active cardiopulmonary disease;
- •breastfeeding or pregnancy;
- •ampullary tumour.
结局指标
主要结局
The incidence and severity of post-ERCP pancreatitis
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
- the incidence of hyperamylasemia(up to 1 months)
- the incidence of other ERCP-related adverse events(within 30 days after ERCP)
- the rate of stenting success(Intra-procedure)