Endoscopic Pancreatic Duct Stent Placement Versus Conventional Approach in the Treatment of Early Phase Acute Pancreatitis: International Multicenter Controlled Randomized Prospective Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- Mortality rate
研究概览
简要总结
The planned multicenter randomized study is aimed to assess the efficacy and safety of endoscopic pancreatic duct stenting in adult patients with acute pancreatitis. It is planned to include patients with early-stage nonbiliary pancreatitis in the study.
详细描述
Endoscopic pancreatic duct stent placement is used to treat a variety of pancreatic diseases, including chronic pancreatitis, Wirsung duct strictures, pseudocysts in disconnected duct syndrome and as a preventive measure after endoscopic retrograde cholangiopancreatography. Despite the obvious progress, the greatest number of unsolved problems remain in the issues of using this manipulation in patients with acute pancreatitis. In particular, the perspectives of the pancreatic duct stent placement in treatment of acute pancreatitis early stages remain controversial.
On the one hand, the installation of a stent in the early acute pancreatitis stages helps to normalize the outflow of pancreatic juice from the pancreas and reduce intraductal pressure, leading to a beneficial effect, as evidenced by a number of researchers. On the other hand, stent placement may partially block the second-order pancreatic ducts or increase the risk of sterile pancreatitis contamination due to the development of reflux. In addition, one should not forget about a number of post-manipulation complications inherent in this procedure, including bleeding from the area of the major duodenal papilla, perforation of the duodenum, progression of pancreatic necrosis and cholangitis. Finally, the timing and indications for early endoscopic stenting of the pancreatic duct are not currently standardized, largely due to the fact that acute pancreatitis is a pathological condition that is difficult to predict.
Thus, although this manipulation seems perspective, due to the lack of evidence base, it is currently difficult to recommend it for use in wide clinical practice.
The planned multicenter randomized study is aimed to assess the efficacy and safety of endoscopic pancreatic duct stenting in adult patients with acute pancreatitis. It is planned to include patients with early-stage nonbiliary pancreatitis in the study.
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
- None
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
- •Diagnosis of acute pancreatitis confirmed on the basis of at least 2 of the 3 diagnostic criteria according to the revised Atlanta classification
- •Presence of organ failure signs (moderate and severe pancreatitis)
- •Informed consent of the patient
排除标准
- •Presence of other indications for endoscopic intervention on the major duodenal papilla (biliary pancreatitis with cholangitis, calculus of the major duodenal papilla, stenosis of the major duodenal papilla, etc.)
- •Previous surgical interventions on the major duodenal papilla
- •Diverticula of the major duodenal papilla
- •Coagulopathy (INR>1.5, blood platelets < 50*109/l
研究组 & 干预措施
Сomparison group
Treatment measures will be performed in accordance with clinical guidelines and will include infusion therapy, pain relief, and nutritional support. Surgical interventions will also be performed based on estimated indications.
干预措施: Conventional treatment of acute pancreatitis in early phase (Drug)
Study group
Along with the generally accepted complex of therapeutic measures, endoscopic pancreatic duct stent placement will be performed
干预措施: Endoscopic pancreatic duct stent placement (Procedure)
结局指标
主要结局
Mortality rate
时间窗: From enrollment to the end of treatment at 3 months
Data will be tabulated and statistically analyzed in terms of percentages
次要结局
- Average Balthazar computed tomography severity index (0-10)(From enrollment to the 7th day of treatment)
- Number of participants with manifestation of diabetes mellitus(From enrollment to the end of treatment at 3 months)
- Length of hospital stay(From date of hospitalization until the date of discharge, assessed up to 3 months)
- Average SOFA (Sequential Organ Failure Assessment Score) score (0-24)(From enrollment to the 7th day of treatment)
- Incidence of other surgical interventions(From enrollment to the end of treatment at 3 months)
- Incidence of complications associated with endoscopic pancreatic duct stent placement(From endoscopic pancreatic duct stent placement to 3 months)
- Number of participants with other surgical interventions(From enrollment to the end of treatment at 3 months)
- Rate of different pancreatic necrosis models(From enrollment to the 7th day of treatment)
研究者
Kotkov Pavel
MD, associate professor of the General Surgery Department Almazov National Medical Research Centre
Almazov National Medical Research Centre