Liver Cirrhosis Clinical Trial
Official title:
Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Variceal Rebleeding in Cirrhotic Patients With Occlusive Portal Vein Thrombosis (PVT) and Cavernous Transformation of the Portal Vein (CTPV)
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 14 Years to 75 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Department of Radiology | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Zaibo Jiang |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Variceal rebleeding | Variceal rebleeding rate in 3 years | 3 years | No |
Secondary | Overall survival time | 3 years | No | |
Secondary | Variceal rebleeding-related death rate | 3 years | No | |
Secondary | Treatment-related complications | Incidence of treatment-related complications | 3 years | Yes |
Secondary | Transjugular intrahepatic portosystemic shunt success rate | Technical success rate of transjugular intrahepatic portosystemic shunt | 3 years | No |
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