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 range14 Years – 75 Years
SexALL
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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.