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

NCT ID: NCT02853526

Last Updated: 2016-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2018-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TIPS arm

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.

Group Type: EXPERIMENTAL

TIPS

Intervention Type: PROCEDURE

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.

Warfarin

Intervention Type: DRUG

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.

conservative treatment arm

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

Group Type: ACTIVE_COMPARATOR

Propranolol

Intervention Type: DRUG

Propranolol is a kind of non-selective beta blockers, and is used for reducing the portal pressure.

Endoscopic therapy

Intervention Type: PROCEDURE

Endoscopic therapy includes the endoscopic variceal band ligation and sclerotherapy.

Warfarin

Intervention Type: DRUG

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.

Interventions

TIPS

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.

Intervention Type: PROCEDURE

Propranolol

Propranolol is a kind of non-selective beta blockers, and is used for reducing the portal pressure.

Intervention Type: DRUG

Endoscopic therapy

Endoscopic therapy includes the endoscopic variceal band ligation and sclerotherapy.

Intervention Type: PROCEDURE

Warfarin

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.

Intervention Type: DRUG

Other Intervention Names

Transjugular intrahepatic portosystemic shunt

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zaibo Jiang

OTHER

Sponsor Role: lead

Responsible Party

Zaibo Jiang

Head of the intervention and vascular surgery department, the Third Affiliated Hospital, Sun Yat-sen University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Zaibo Jiang

Role: PRINCIPAL_INVESTIGATOR

Department of Intervention and Vascular Surgery, the Third Affiliated Hospital, Sun Yat-sen University

Locations

Department of Radiology

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Tao Pan

Role: CONTACT

pant5@mail2.sysu.edu.cn

8602085252066

Zaibo Jiang

Role: CONTACT

jiangzaibo@aliyun.com

8602085253416

Facility Contacts

Zaibo Jiang, MD.

Role: primary

jiangzaibo@aliyun.com

+86 020 85253416

Other Identifiers

TIPSVRDORNO3HSYSU

Identifier Type: -

Identifier Source: org_study_id