跳至主要内容
临床试验/NCT05716594
NCT05716594招募中2 期

Clinical Evaluation of Enteral-extended Anti-reflux Stents for Pancreatic Pseudocyst

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
入组人数
52
试验地点
1
主要终点
Disappearance rate of pseudocyst(PDR) after stent implantation

研究概览

简要总结

At present, endoscopic therapy is the preferred method to solve biliary or pancreatic diseases. And EUS-guided stent implantation and drainage of pancreatic pseudocyst is the main method in Endoscopic treatment of pancreatic pseudocyst. However, blockage of stent is a problem that has puzzled endoscopists for a long time. The mechanism of stent blockage is related to the reflux of gastrointestinal contents into the stent. Although plastic stents are widely used in patients who needed drainage. However, the average free time for stent is only 77 to 126 days, leading to the need for stent replacement in most patients within 3 months. As one end of the double pigtail stent used for drainage of pancreatic pseudocyst may be located in the stomach, it may cause the stent to be blocked by the contents of the stomach. Therefore, multiple stents or additional stents or drainage tube are often needed to further strengthen the drainage.

It seems that the mechanism of stent blockage are associated with gastrointestinal contents reflux. And stents required be replaced again by endoscopic approach when jamming. However, EUS and ERCP are difficult, costly, and may be with complications. Additional operations will increase the risks and costs. Therefore, a stent that can effectively prevent reflux, solve clinical problems, and effectively prolong stent patency time is urgently needed.

详细描述

At present, endoscopic therapy is the preferred method to solve biliary or pancreatic diseases. And EUS-guided stent implantation and drainage of pancreatic pseudocyst is the main method in Endoscopic treatment of pancreatic pseudocyst. However, blockage of stent is a problem that has puzzled endoscopists for a long time. The mechanism of stent blockage is related to the reflux of gastrointestinal contents into the stent. Although plastic stents are widely used in patients who needed drainage. However, the average free time for stent is only 77 to 126 days, leading to the need for stent replacement in most patients within 3 months. As one end of the double pigtail stent used for drainage of pancreatic pseudocyst may be located in the stomach, it may cause the stent to be blocked by the contents of the stomach. Therefore, multiple stents or additional stents or drainage tube are often needed to further strengthen the drainage.

It seems that the mechanism of stent blockage are associated with gastrointestinal contents reflux. And stents required be replaced again by endoscopic approach when jamming. However, EUS and ERCP are difficult, costly, and may be with complications. Additional operations will increase the risks and costs. Therefore, a stent that can effectively prevent reflux, solve clinical problems, and effectively prolong stent patency time is urgently needed.

The extended enteral anti-reflux stent developed by our research team has potential advantages in prolonging the patency period of the stent and preventing secondary infection of pseudocysts. In this study, we aim to evaluate the effect of the stent on the drainage of pancreatic pseudocyst.

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 (Participant, Investigator)

入排标准

年龄范围
12 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pancreatic pseudocyst by a variety of causes, including acute pancreatitis, chronic pancreatitis, drug-induced pancreatitis
  • Pseudocyst compressed gastrointestinal or bile duct and causes obstruction symptoms or causes other symptoms
  • Diameter of pseudocyst >6 cm with no compression symptoms, but progressively increases and is failed to conservatively treat

排除标准

  • Wall-off necrosis with liquidation mimics pseudocyst
  • Pseudocyst formation ≤8 weeks, cyst wall is immature
  • Cannot puncture by EUS-guided approach for any reason
  • Patients with serious cardiovascular or cerebrovascular diseases or other diseases which are not fitted to anaesthetize
  • Severe coagulopathy or thrombocytopenia

结局指标

主要结局

Disappearance rate of pseudocyst(PDR) after stent implantation

时间窗: in 6 months

PDR=1-(Postoperative pseudocyst area/Preoperative pseudocyst area)×100%

次要结局

  • Time of disappearance of pseudocyst after stent implantation(in 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Huang Yonghui

Chief Physician

Peking University Third Hospital

研究点 (1)

Loading locations...

相似试验

Clinical Evaluation of Enteral-extended Anti-reflux... | 临床试验