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

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Peking University Third Hospital
RECRUITING
Beijing
Contact Information
Primary
Yonghui Huang, archiater
chengzhuopku@163.com
13911765322
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 52
Treatments
Experimental: Enteral-extended Anti-reflux Stents Group
Patients are going to implant enteral-extended anti-reflux stents
Active_comparator: Traditional Stents Group
Patients are going to implant traditional stents
Related Therapeutic Areas
Sponsors
Leads: Peking University Third Hospital

This content was sourced from clinicaltrials.gov