Liver Cirrhoses
Conditions
Keywords
Liver Cirrhosis, Transjugular Intrahepatic Portosystemic shunt, Refractory ascites
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.
Interventions
PROCEDURETIPS
Transjugular intrahepatic portosystemic shunt with covered PTFE
PROCEDUREparacentesis
paracentasis plus albumine invision
Sponsors
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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 * Pregnant or breast feeding women * Refusal to participate or patient unable to receive informations or to sign written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transplant-free survival | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of paracentesis | 12 months | — |
| Frequency of overt Hepatic Encephalopathy | 12 months | Number of episodes of West Haven grade 2 or greater without precipitating factor |
| Nutritional status | 12 months | — |
| Quality of life | 12 months | — |
| Other Liver Disease Complications (Adverse Events) | 12 months | — |
Countries
China
Contacts
Primary ContactGuohong Han, MD&PhD
Backup ContactHui Chen, MD&PhD
Outcome results
None listed