Efficacy and Safety of HANAROSTEN® HOT Plumber™ With Z-EUSIT™ for Pancreatic Pseudocyst Drainage
Recruiting · NCT06855485 · Interventional (participants receive a specific treatment) · Lead sponsor: Asan Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this prospective, single-center observational study is to evaluate the safety and effectiveness of the HANAROSTEN® HOT Plumber™ with Z-EUSIT™ for draining pancreatic pseudocysts. The main questions the study aims to answer are: * Does the device reduce the size of pancreatic pseudocysts by at least 50% and improve associated symptoms within 30 to 60 days? * Can the stent be successfully placed, retained, and removed without complications? Participants will: * Undergo endoscopic ultrasound-guided transgastric or transduodenal drainage of pancreatic pseudocysts using the HANAROSTEN® HOT Plumber™ with Z-EUSIT™. * Be monitored for adverse events such as bleeding, infection, stent migration, or tissue injury. * Return for follow-up visits within 30 or 60 days for stent removal and evaluation of clinical success. The study will: * Enroll 20 adults aged 18 years or older who meet the inclusion criteria. * Conduct follow-up assessments until one month after stent removal.
Who can take part
Inclusion criteria
- Must be 18 years or older
- Diagnosed with pancreatic or peripancreatic pseudocyst or walled-off necrosis (with less than 30% solid components)
- Eligible for endoscopic ultrasound-guided drainage
- Able to provide informed consent and comply with study procedures
Exclusion criteria
- Younger than 18 years old
- Pseudocysts with the following characteristics:
- Immature pseudocyst
- Cystic neoplasm
- Pseudoaneurysm
- Multiple pseudocysts requiring drainage
- Uncontrolled coagulation disorders:
- INR \> 1.5
- Platelet count \< 50,000/mm³
- Other bleeding disorders
- Ineligibility for EUS-guided drainage due to anatomical or technical reasons
- History of anaphylactic reaction to stent materials
- Pregnant or potentially pregnant women
- Current participation in another clinical trial that may affect study outcomes
Where it is running
1 location listed.
- Asan Medical Center - Seoul, Seoul, South Korea