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

Phase 3

• Conditions: Portal Vein Thrombosis; Liver Cirrhosis; Portal Vein, Cavernous Transformation of; Bleeding Esophageal Varices
• Interventions: Procedure: TIPS; Drug: Propranolol; Procedure: Endoscopic therapy; Drug: Warfarin

• Registration Number: NCT02853526
• Lead Sponsor: Zaibo Jiang

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-07
• Status Verified: 2016-07
• Study First Submitted: 2016-07-24
• Study First Submitted QC: 2016-07-29
• Last Update Submitted: 2016-07-29
• Study First Posted: 2016-08-03
• Last Update Posted: 2016-08-03
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TIPS arm	TIPS	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.
conservative treatment arm	Endoscopic therapy	Conservative treatment including endoscopic therapy，non-selective beta blockers (propranolol)and anticoagulation therapy (warfarin).
TIPS arm	Warfarin	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.
conservative treatment arm	Propranolol	Conservative treatment including endoscopic therapy，non-selective beta blockers (propranolol)and anticoagulation therapy (warfarin).
conservative treatment arm	Warfarin	Conservative treatment including endoscopic therapy，non-selective beta blockers (propranolol)and anticoagulation therapy (warfarin).

Primary Outcome Measures

Name	Time	Method
Variceal rebleeding	3 years	Variceal rebleeding rate in 3 years

Secondary Outcome Measures

Name	Time	Method
Overall survival time	3 years
Transjugular intrahepatic portosystemic shunt success rate	3 years	Technical success rate of transjugular intrahepatic portosystemic shunt
Treatment-related complications	3 years	Incidence of treatment-related complications
Variceal rebleeding-related death rate	3 years

Trial Locations

Locations (1)

Department of Radiology; 🇨🇳 Guangzhou, Guangdong, China