Comparison of Success Rate and Complication Between Conventional Angiocatheter Versus New Anchoring Device (KARAHOC) Used for Paracentesis in Cirrhotic Patients With Ascites
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Comparison of success rate between conventional angiocatheter versus KARAHOC device used for paracentesis
研究概览
简要总结
Comparison of success rate and complication between conventional angiocatheter versus new anchoring device (KARAHOC) used for paracentesis in cirrhotic patients with ascites.
详细描述
This study is a multi-center, prospective, interventional study, in which subjects who meet the selection criteria are registered at each institution during the study period from the date of research approval. Regardless of the order, paracentesis using KARAHOC and conventional angiocatheter will be performed once in all patients. The criteria for successful paracentesis is set as 3L or more of ascites drainage. During paracentesis, albumin will be infused in all patients. Heart rate and blood pressure will be measured before the procedure and right after the completion of drainage, and 30 minutes later. The incidence of complications will be compared between two methods. In addition, patient and operator satisfaction will be investigated using a visual analogue scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult over the age of 19
- •Patients with pathological or clinical diagnosis of liver cirrhosis
- •Patients with Grade 2 or higher grade of ascites as a complication due to portal hypertension
- •Patients requiring periodic paracentesis
- •Patients consent to this study
排除标准
- •(If at least one of the following conditions apply)
- •Patients with ascites due to peritoneal metastasis due to malignant tumor
- •Patients with high bleeding risk (PT INR>3, PLT<30,000/mm3) difficult to perform ascites puncture
- •Patients with hepatic encephalopathy or hepatorenal syndrome(HRS)
- •Patients with severe cardiovascular disease, lung disease, or DIC
- •Patients refusing paracentesis
- •Patients who can control ascites using diuretics
- •Pregnancy
结局指标
主要结局
Comparison of success rate between conventional angiocatheter versus KARAHOC device used for paracentesis
时间窗: through study completion, an average of 1 year
The criterion for successful paracentesis is defined as drainage of 3L or more at an initial attempt.
次要结局
- operator satisfaction for each procedure(through study completion, an average of 1 year)
- Number of Participants with repeated paracentesis(through study completion, an average of 1 year)
- comparison of complication rate(through study completion, an average of 1 year)
- patient satisfaction for each procedure(through study completion, an average of 1 year)
研究者
Sang Gyune Kim
Professor
Soonchunhyang University Hospital