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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pancreatic Pseudocyst

Intervention / Treatment
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* Combination Product: Plant enteral-extended anti-reflux stents
* Combination Product: Plant traditional stents


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enteral-extended Anti-reflux Stents Group<br>Patients are going to implant enteral-extended anti-reflux stents | Combination Product: Plant enteral-extended anti-reflux stents<br>* Plant enteral-extended anti-reflux stents in EUS-guided drainage of pancreatic pseudocysts<br>|
| Active Comparator: Traditional Stents Group<br>Patients are going to implant traditional stents | Combination Product: Plant traditional stents<br>* Plant traditional stents in EUS-guided drainage of pancreatic pseudocysts<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disappearance rate of pseudocyst（PDR） after stent implantation | PDR=1-(Postoperative pseudocyst area/Preoperative pseudocyst area)×100% | in 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of disappearance of pseudocyst after stent implantation | Time of disappearance of pseudocyst after stent implantation | in 6 months |