Early Use of TIPS With Polytetrafluoroethylene(PTFE) Covered Stents in Cirrhotic Patients With Re… (NCT03172273) | Clinical Trial Compass
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Early Use of TIPS With Polytetrafluoroethylene(PTFE) Covered Stents in Cirrhotic Patients With Refractory Ascites
China180 participantsStarted 2017-06-29
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Transplant-free survival
Timeframe: 12 months
Trial details
NCT IDNCT03172273
SponsorAir Force Military Medical University, China