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Trial Title:
Clinical Evaluation of Enteral-extended Anti-reflux Stents for Pancreatic Pseudocyst
NCT ID:
NCT05716594
Condition:
Pancreatic Pseudocyst
Conditions: Official terms:
Pancreatic Pseudocyst
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Combination Product
Intervention name:
Plant enteral-extended anti-reflux stents
Description:
Plant enteral-extended anti-reflux stents in EUS-guided drainage of pancreatic
pseudocysts
Arm group label:
Enteral-extended Anti-reflux Stents Group
Intervention type:
Combination Product
Intervention name:
Plant traditional stents
Description:
Plant traditional stents in EUS-guided drainage of pancreatic pseudocysts
Arm group label:
Traditional Stents Group
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
12 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University Third Hospital
Address:
City:
Beijing
Zip:
100101
Country:
China
Status:
Recruiting
Contact:
Last name:
Yonghui Huang, archiater
Phone:
13911765322
Email:
chengzhuopku@163.com
Start date:
March 1, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Peking University Third Hospital
Agency class:
Other
Source:
Peking University Third Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05716594
