TIPS for Variceal Rebleeding in Cirrhotic Patients With Occlusive Portal Vein Thrombosis and CTPV (NCT02853526) | Clinical Trial Compass
UnknownPhase 3
TIPS for Variceal Rebleeding in Cirrhotic Patients With Occlusive Portal Vein Thrombosis and CTPV
China100 participantsStarted 2015-07
Plain-language summary
To date, there is no treatment strategies for these patients according to American Association of the Study of Liver Disease (AASLD) practice guidelines and Baveno V consensus. Thus, we aim to compare the safety and efficacy of TIPS and conservative treatment (non-selective beta blockers, endoscopic therapy and/or anticoagulation) in patients with PVT and CPTV.
Who can participate
Age range
14 Years – 75 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:
* All patients diagnosis with portal vein thrombosis and cavernous transformation of portal vein and portal hypertension by contrast enhanced CT or MRI.
* History of variceal bleeding.
* Liver cirrhosis.
* Neutrophilous counts≥ 1.5×109/L, Platelet counts ≥ 50 × 109/L, Hemoglobin≥ 85g/L.
* Albumin ≥2.8 g/dL, total bilirubin \<51.3 umol/L; alanine aminotransferase (ALT) and aspartate transaminase（AST）\<5 times of upper limit.
* PT(Prothrombin time)-INR(international normalized ratio) \< 1.7.
Exclusion Criteria:
* Thrombosis involve superior mesenteric vein, splenic vein, or the whole portal vein system. Not suitable for TIPS (judged by principal investigator).
* Company with malignant tumors in liver or other organs.
* Patients with known severe dysfunction of heart, lung, brain or kidney.
* Active bleeding.
* Not eligible for anticoagulation therapy,non-selective beta blockers or endoscopic therapy.
* Uncontrolled infection.
* Pregnancy and breastfeeding.
* HIV infection.
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.