TIPS for Variceal Rebleeding in Cirrhotic Patients With Occlusive Portal Vein Thrombosis and CTPV

Zaibo Jiang

Status and phase: Unknown; Phase 3

Conditions: Liver Cirrhosis; Bleeding Esophageal Varices; Portal Vein Thrombosis; Portal Vein, Cavernous Transformation of

Treatments: Procedure: TIPS; Drug: Warfarin; Drug: Propranolol; Procedure: Endoscopic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02853526

TIPSVRDORNO3HSYSU

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 14 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

TIPS arm

Experimental group

Description:

Transjugular intrahepatic portosystemic shunt(TIPS) is an artificial channel within the liver that establishes communication between the inflow portal vein and the outflow hepatic vein. It is used to treat portal hypertension.TIPS was performed in a conventional fashion or in combination of percutaneous transhepatic or transsplenic approach (also called p-TIPS or modified 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.

Treatment:

Drug: Warfarin

Procedure: TIPS

conservative treatment arm

Active Comparator group

Description:

Conservative treatment including endoscopic therapy，non-selective beta blockers (propranolol)and anticoagulation therapy (warfarin).

Treatment:

Drug: Propranolol

Drug: Warfarin

Procedure: Endoscopic therapy