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.
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
Younger than 18 years old
Immature pseudocyst
Cystic neoplasm
Pseudoaneurysm
Asan Medical Center
Lead sponsor
M.I.Tech Co., Ltd.
Collaborator