Evaluation of a new anti-reflux stent for pancreatic pseudocysts
Clinical Evaluation of Enteral-extended Anti-reflux Stents for Pancreatic Pseudocyst
This study is testing a new type of stent for people with pancreatic pseudocysts to see if it can stay clear longer and reduce the need for replacements compared to regular stents.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 12 Years to 90 Years |
| Sex | All |
| Sponsor | Peking University Third Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05716594 on ClinicalTrials.gov |
What this trial studies
This clinical evaluation focuses on the use of enteral-extended anti-reflux stents for the treatment of pancreatic pseudocysts. The study aims to address the common issue of stent blockage caused by the reflux of gastrointestinal contents, which often necessitates frequent stent replacements. By comparing the new anti-reflux stents with traditional stents, the research seeks to determine if the new design can prolong stent patency and reduce complications associated with current treatment methods. The study will involve patients with pancreatic pseudocysts that meet specific criteria, and it will be conducted at Peking University Third Hospital.
Who should consider this trial
Good fit: Ideal candidates include patients with pancreatic pseudocysts larger than 6 cm that are causing obstruction symptoms or have failed conservative treatment.
Not a fit: Patients with wall-off necrosis, immature cyst walls, or serious comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for stent replacements and improve patient outcomes in managing pancreatic pseudocysts.
How similar studies have performed: While the approach of using anti-reflux stents is innovative, similar studies have not been widely reported, making this a potentially novel intervention.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing
- Peking University Third Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Yonghui Huang, archiater — Peking University Third Hospital
- Study coordinator: Yonghui Huang, archiater
- Email: chengzhuopku@163.com
- Phone: 13911765322
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.