Impact of Transjugular Intrahepatic Portosystemic Shunts on Liver Stiffness
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Decrease in Liver Stiffness
研究概览
简要总结
Pilot study examining changes in liver stiffness measured by ultrasound before and after TIPS creation
详细描述
Single arm pilot study of adults ≥18yo investigating changes in liver stiffness as measured by ultrasound acoustic radiation force impulse (ARFI) before and after creation of TIPS. Duration of participation is 30 days from TIPS creation. TIPS creation with Viatorr stent graft will be in accordance with its FDA-approved indication for symptomatic portal hypertension and per the manufacturer's instructions for use. Liver stiffness will be measured on pre-TIPS and post-TIPS ultrasounds using Phillips Epiq Ultrasound systems equipped with ElastPQ ultrasound shear wave elastography. Both ultrasounds will be performed at times which are standard of care before and after TIPS creation. Primary objectives include liver stiffness as measured by ultrasound acoustic radiation force impulse (ARFI) before and after creation of TIPS. Secondary objectives include change in portosystemic gradient, clinical success as measured by difference in frequency of repeat paracentesis post-TIPS or freedom from recurrence of variceal bleeding and rate of hepatic encephalopathy. Exploratory objectives include serum biomarkers of liver stiffness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic portal hypertension secondary to cirrhosis undergoing elective outpatient TIPS
- •Age >18, Age <80
- •Capable of giving informed consent
排除标准
- •Coagulopathy defined as international normalized ration (INR) >2 which cannot be corrected with fresh frozen plasma
- •Platelet count <50,000/microliter, which cannot be corrected with platelet transfusion
- •BMI >35 and/or cirrhosis due to non-alcoholic steatohepatitis (due to inaccurate elastography measurements in patients with fatty liver)
- •Urgent or emergent TIPS for bleeding
- •Portal vein thrombosis with in the main, 1st, or 2nd order branches of the portal vein
- •Hepatic vein thrombosis (ie no Budd Chiari syndrome)
- •Excessive alcohol use defined as more than 2 oz in 24 hours on any individual day within the last 30 days
- •Inability to provide informed consent
- •Pregnant or nursing women
- •Enrollment in concurrent therapeutic trial for symptomatic portal hypertension
研究组 & 干预措施
Open Label
All enrolled participants will undergo hepatic ultrasound with acoustic radiation force impulse (ARFI) before and 30 days after creation of TIPS.
干预措施: Ultrasound (Diagnostic Test)
结局指标
主要结局
Decrease in Liver Stiffness
时间窗: Pre-TIPS and 30 days Post-TIPS creation
The primary study endpoint will be decrease in liver stiffness following TIPS creation as measured by ARFI using mean propagation velocity values in meters per second. Mean normal values and mean values indicating severe fibrosis range about 0.8-1.7 m/s and about 1-3.4 m/s respectively. We hypothesize TIPS creation will reduce the liver stiffness by \> 50%. Change in liver stiffness will be correlated to change in PSG.
次要结局
- Tissue Inhibitor of Metalloproteinase-1 and ARFI Correlation(Pre-TIPS and 30 days Post-TIPS creation)
- PSG (mm hg) and ARFI (m/s) Correlation(Pre-TIPS and 30 days Post-TIPS creation)
- Frequency of Paracentesis and Recurrence of Variceal Bleeding(30 days Post-TIPS and 12 months Post-TIPS creation)
- Hyaluronic Acid and ARFI Correlation(Pre-TIPS and 30 days Post-TIPS creation)