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

NCT05716594 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-02-08

No results posted yet for this study

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.

Conditions

  • Pancreatic Pseudocyst

Interventions

COMBINATION_PRODUCT

Plant enteral-extended anti-reflux stents

Plant enteral-extended anti-reflux stents in EUS-guided drainage of pancreatic pseudocysts

COMBINATION_PRODUCT

Plant traditional stents

Plant traditional stents in EUS-guided drainage of pancreatic pseudocysts

Sponsors & Collaborators

  • Peking University Third Hospital

    lead OTHER

Principal Investigators

  • Yonghui Huang, archiater · Peking University Third Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2025-07-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05716594 on ClinicalTrials.gov