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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Transplant-free survival
Timeframe: 12 months
Trial details
NCT IDNCT03172273
SponsorAir Force Military Medical University, China