NCT06855485招募中不适用
A Prospective Single-Center Observational Study on the Evaluation of Efficacy and Safety of HANAROSTEN® HOT Plumber™ with Z-EUSIT™ for Pancreatic Pseudocysts Drainage
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Clinical Success
研究概览
简要总结
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.
详细描述
Detailed Description
This prospective, single-center observational study aims to evaluate the safety and effectiveness of the HANAROSTEN HOT Plumber with Z-EUSIT for pancreatic pseudocyst drainage. The study will assess clinical success, defined as a reduction of at least 50% in pseudocyst size accompanied by symptom improvement, as well as technical success, device retention, lumen patency, and adverse events. Follow-up will continue until one month after stent removal.
Study Rationale
- Pancreatic pseudocysts develop due to pancreatic duct obstruction or damage caused by inflammation, resulting in fluid accumulation. Symptoms may include abdominal pain, gastric outlet obstruction, early satiety, and weight loss. Drainage is required when pseudocysts become symptomatic, infected, or increase in size.
- Endoscopic ultrasound-guided transgastric or transduodenal drainage is the standard treatment for accessible pseudocysts. Compared to surgical or percutaneous methods, this approach is less invasive and promotes faster recovery.
- The HANAROSTEN HOT Plumber with Z-EUSIT features an electrocautery-enhanced delivery system, eliminating the need for guidewire exchanges and tract dilation. The stent is made of nitinol wire with silicone coating and anti-migration bi-flanges, designed for easy placement and removal.
Study Design
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Clinical Success
时间窗: Within 30 or 60 days after stent placement
Reduction of pancreatic pseudocyst size by at least 50% with improvement in associated symptoms.
次要结局
- Technical Success - Stent Placement(During procedure)
- Technical Success - Stent Removal(Within 30 or 60 days after placement)
- Stent Retention(Within 30 or 60 days after placement)
- Lumen Patency(Within 30 or 60 days after placement)
- Procedure Duration(During procedure)
- Adverse Events(From procedure day until one month after stent removal)
研究者
Tae Jun Song, MD
Professor
Asan Medical Center
研究点 (2)
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