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

Phase 2

Recruiting

• Conditions: Pancreatic Pseudocyst
• Interventions: Combination Product: Plant enteral-extended anti-reflux stents; Combination Product: Plant traditional stents

• Registration Number: NCT05716594
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-29
• Study First Submitted QC: 2023-01-29
• Last Update Submitted: 2023-01-29
• Study First Posted: 2023-02-08
• Last Update Posted: 2023-02-08
• Study Start: 2023-03-01
• Primary Completion: 2025-07-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enteral-extended Anti-reflux Stents Group	Plant enteral-extended anti-reflux stents	Patients are going to implant enteral-extended anti-reflux stents
Traditional Stents Group	Plant traditional stents	Patients are going to implant traditional stents

Primary Outcome Measures

Name	Time	Method
Disappearance rate of pseudocyst（PDR） after stent implantation	in 6 months	PDR=1-(Postoperative pseudocyst area/Preoperative pseudocyst area)×100%

Secondary Outcome Measures

Name	Time	Method
Time of disappearance of pseudocyst after stent implantation	in 6 months	Time of disappearance of pseudocyst after stent implantation

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China