NCT02853526

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

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)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Zaibo Jiang · Academic / Other
• Sex: All
• Age: 14 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-12-01
• Completion: 2018-12-01
• First posted: 2016-08-03
• Last updated: 2016-08-03

Locations

1 site across 1 country: China