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.
The incidence of portal vein thrombosis (PVT) is about 16% in cirrhotic patients. Chronic PVT often cause two main undesirable consequences: symptomatic portal hypertension (such as variceal bleeding or ascites) and cavernous transformation of portal vein (CPTV). The former could lead to death and the latter increases the difficulty of the transjugular intrahepatic portosystemic shunt (TIPS) treatment, which is considered as a main effective treatment for symptomatic portal hypertension. Some patients with CPTV and variceal bleeding only have to receive conservative treatment (non-selective beta blockers, endoscopic therapy and/or anticoagulation). With advances in technology, modified TIPS procedure could significantly improve the operation success rate of patients with CPTV. To date, the difference in safety and efficacy between TIPS and conservative treatment (non-selective beta blockers, endoscopic therapy and/or anticoagulation) in patients with PVT and CPTV is still unclear.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Transjugular intrahepatic portosystemic shunt(TIPS)- TIPS was performed in a conventional fashion or in combination of percutaneous transhepatic or transsplenic approach (p-TIPS). Oral warfarin was used for six months to one year prescribed at dosages to achieve an international normalized ratio (INR) of up to two times the upper limit of normal for the prevention of shunt dysfunction.
Propranolol is a kind of non-selective beta blockers, and is used for reducing the portal pressure.
Endoscopic therapy includes the endoscopic variceal band ligation and sclerotherapy.
Department of Radiology
Guangzhou, Guangdong, China
RECRUITINGVariceal rebleeding
Variceal rebleeding rate in 3 years
Time frame: 3 years
Overall survival time
Time frame: 3 years
Variceal rebleeding-related death rate
Time frame: 3 years
Treatment-related complications
Incidence of treatment-related complications
Time frame: 3 years
Transjugular intrahepatic portosystemic shunt success rate
Technical success rate of transjugular intrahepatic portosystemic shunt
Time frame: 3 years
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Oral warfarin was used for six months to one year prescribed at dosages to achieve an international normalized ratio (INR) of up to two times the upper limit of normal.