A Prospective, Multicenter, Randomized Study Evaluating Portal Vein Access Sets During Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedures
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 5
- 主要终点
- Number of Participants With Procedural Success
研究概览
简要总结
Creation of the parenchymal tract between the portal vein and the hepatic vein is the most difficult and time consuming step in a TIPS procedure. The purpose of this study is to evaluate portal vein access sets during the TIPS procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •≥ 18 years of age at the time of the TIPS procedure
- •TIPS procedure initiated for refractory variceal bleeding, refractory ascites and/or hydrothorax
- •Willing and able to provide written informed consent and HIPAA (Health Insurance Portability and Accountability Act) authorization
- •Willing and able to comply with the study procedures and follow up schedule
排除标准
- •Known active malignancy
- •MELD score ≥ 18 at time of screening
- •History of polycystic liver disease
- •Active bleeding from any source
- •Pulmonary hypertension, heart failure, severe tricuspid valve dysfunction, right to left cardiopulmonary shunt
- •Chronic, occlusive portal vein thrombosis or complete portal vein thrombosis of the main or target portal vein on prior CT examination
- •Active or uncontrolled hepatic encephalopathy
- •Systemic infection/sepsis
- •Biliary obstruction
- •Uncorrectable coagulopathy
- •Any diminutive or partially thrombosed right portal vein
- •Hepatic vein thrombosis (i.e., no Budd-Chiari syndrome)
- •Known sensitivity to contrast or serious contrast reaction such as anaphylaxis
- •Pregnant women or women who are planning to become pregnant
研究组 & 干预措施
TIPS with Scorpion Portal Vein Access Kit
Scorpion or Scorpion X access set
干预措施: Scorpion Portal Vein Access Kit (Device)
TIPS with Scorpion Portal Vein Access Kit
Scorpion or Scorpion X access set
干预措施: Transjugular Intrahepatic Portosystemic Shunt (TIPS) (Procedure)
TIPS with Cook Transjugular Liver Access Set
Ring or Rosch-Uchida access set
干预措施: Cook Transjugular Liver Access Set (Device)
TIPS with Cook Transjugular Liver Access Set
Ring or Rosch-Uchida access set
干预措施: Transjugular Intrahepatic Portosystemic Shunt (TIPS) (Procedure)
结局指标
主要结局
Number of Participants With Procedural Success
时间窗: TIPS Procedure (Day 0), up to 93 minutes
Creation of the parenchymal tract between the hepatic vein and an intrahepatic branch of the portal vein confirmed by portogram (CO2/contrast).
Composite of Major Complications
时间窗: Through 30 days post-TIPS procedure
Major complications associated with the procedure or study device and defined as complications resulting in an unplanned increase in the level of care, prolonged hospitalization, permanent adverse sequelae, or death.
次要结局
- Portal Vein Access (PVA) Time(TIPS Procedure (Day 0), up to 52 minutes)
- Number of Participants With Technical Success(TIPS Procedure (Day 0), up to 93 minutes)
- Number of Needle Passes(TIPS Procedure (Day 0), up to 93 minutes)
- Procedure Duration(TIPS Procedure (Day 0), up to 93 minutes)
- Fluoroscopy Time(TIPS Procedure (Day 0), up to 31.5 minutes)
- Device-Related Complications(Through 30 days post-TIPS procedure)