Efficacy and Safety of HANAROSTEN® HOT Plumber™ With Z-EUSIT™ for Pancreatic Pseudocyst Drainage

Summary

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.

Eligibility

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

Conditions2

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