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

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02853526
• Other study ID #: TIPSVRDORNO3HSYSU
• Status: Recruiting
• Phase: Phase 3
• First received: July 24, 2016
• Last updated: July 29, 2016
• Start date: July 2015
• Est. completion date: December 2018

Study information

• Verified date: July 2016
• Source: Sun Yat-sen University
• Contact: Tao Pan
• Phone: 8602085252066
• Email: pant5[@]mail2.sysu.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bleeding Esophageal Varices
• Esophageal and Gastric Varices
• Gastrointestinal Hemorrhage
• Hypertension, Portal
• Liver Cirrhosis
• Portal Vein Thrombosis
• Portal Vein, Cavernous Transformation of
• Thrombosis
• Venous Thrombosis

Intervention

Procedure:
• 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.

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

Procedure:
• Endoscopic therapy
Endoscopic therapy includes the endoscopic variceal band ligation and sclerotherapy.

Drug:
• 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.

Locations

Country	Name	City	State
China	Department of Radiology	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zaibo Jiang

Country where clinical trial is conducted

China, 

Outcome

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