NCT03172273
Recruiting
Not Applicable
Early Use of Transjugular Intrahepatic Portosystemic Shunt（TIPS）With Polytetrafluoroethylene(PTFE) Covered Stents in Cirrhotic Patients With Refractory Ascites
Air Force Military Medical University, China2 sites in 1 country180 target enrollmentJune 29, 2017
ConditionsLiver Cirrhoses
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Liver Cirrhoses
- Sponsor
- Air Force Military Medical University, China
- Enrollment
- 180
- Locations
- 2
- Primary Endpoint
- Transplant-free survival
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
This multicenter RCT is designed to investigate if TIPS with covered stents improves transplant-free survival for cirrhotic patients with early stage of refractory ascites compared to LVP+albumin during 1 year follow-up period.
Investigators
Guohong Han
PhD&MD
Xi'an International Medical Center Hospital
Eligibility Criteria
Inclusion Criteria
- •Confirmed diagnosis of liver cirrhosis
- •Recurrent and refractory ascites
- •Patients with an age between 18 and 65 years old
- •Child-Pugh ≤12
- •Absence of hepatic encephalopathy
- •Patient is willing and able to comply with all study protocol requirements, including specified follow-up and testing.
- •Patient, or legal authorized representative, is willing to provide written informed consent prior to enrollment in the study
Exclusion Criteria
- •With more than 6 paracenteses within the last 3 months
- •patients expected to receive transplants within the next 6 months or on waiting list
- •Usual contra-indication for TIPS: congestive heart failure NYHA\>III or medical history of pulmonary hypertension, portal vein thrombosis（\>50%）, hepatic polycystosis, intra-hepatic bile ducts dilatation
- •Patient has had previous TIPS placement
- •Severe liver dysfunction by: Prothrombin index \< 40% or total bilirubin \> 50μmol/l
- •Serum creatinine \>133μmol/l
- •Severe hyponatremia \<125mmol / L
- •Uncontrolled sepsis
- •Gastrointestinal hemorrhage within 6 weeks of randomization
- •Known allergy to albumin
Outcomes
Primary Outcomes
Transplant-free survival
Time Frame: 12 months
Secondary Outcomes
- Frequency of paracentesis(12 months)
- Quality of life(12 months)
- Frequency of overt Hepatic Encephalopathy(12 months)
- Nutritional status(12 months)
- Other Liver Disease Complications (Adverse Events)(12 months)
Study Sites (2)
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