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Recruiting NCT05716594

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

Conditions: Pancreatic Pseudocyst

Sex: All
Ages: 12 Years – 90 Years
Phase: PHASE2
Enrollment: 52
Sponsor: Peking University Third Hospital

Location: China

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.

Eligibility Criteria

Inclusion Criteria:Pancreatic pseudocyst by a variety of causes, including acute pancreatitis, chronic pancreatitis, drug-induced pancreatitisPseudocyst compressed gastrointestinal or bile duct and causes obstruction symptoms or causes other symptomsDiameter of pseudocyst >6 cm with no compression symptoms, but progressively increases and is failed to conservatively treatExclusion Criteria:Wall-off necrosis with liquidation mimics pseudocystPseudocyst formation ≤8 weeks, cyst wall is immatureCannot puncture by EUS-guided approach for any reasonPatients with serious cardiovascular or cerebrovascular diseases or other diseases which are not fitted to anaesthetizeSevere coagulopathy or thrombocytopenia

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05716594). StuddyBuddy aggregates publicly available trial information.