Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Prevention of Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis

Air Force Military Medical University of People's Liberation Army

Status: Completed

Conditions: Decompensated Cirrhosis; Bleeding Varices; Portal Vein Thrombosis

Treatments: Procedure: ET+NSBB; Procedure: Transjugular intrahepatic portosystemic shunt (TIPS)

Study type: Interventional

Funder types: Other

Identifiers

NCT01326949

1PVT-TIPS

Details and patient eligibility

About

Portal vein thrombosis (PVT) refers to an obstruction in the trunk of the portal vein. It can extend downstream to the portal branches, or upstream to the splenic and/or the mesenteric veins. The prevalence of PVT is 10-25% and incidence is about 16% in cirrhotic patients. Recent studies demonstrate that the presence of PVT is not only an independent predictor of failure to control active variceal bleeding and prevent variceal rebleeding, but also significantly associated with increased mortality in patients with liver cirrhosis.

However, in recent American Association of the Study of Liver Disease (AASLD) practice guidelines and Baveno V consensus, no treatment strategies in cirrhotic patients with PVT was clearly recommended due to the absence of randomized controlled trials.

Full description

Usually, cirrhotic patients with PVT are submitted to variceal rebleeding prophylaxis with endoscopic band ligation combined with non-selective beta-blockers and, when necessary, the anticoagulation is started after the varices eradication.

TIPS is just regarded as the second-line therapy for the secondary prophylaxis of variceal bleeding in cirrhotic patients. However, this indication might be changed in the setting of PVT. Indeed, the risk to benefit ratio of TIPS in cirrhotic patients with PVT for the prevention of recurrent variceal bleeding has never been evaluated.

The aim of this study is to compare the efficacy and safety of TIPS and endoscopic band ligation + propranolol in decompensated cirrhosis patients with PVT and a history of variceal bleeding in the past 6 weeks.

Enrollment: 52 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent
• Liver cirrhosis
• Portal vein thrombosis (degree of vessel obstruction > 50%)
• History of variceal hemorrhage in the past 6 weeks (recent variceal bleeding has been controlled for at least 120 hours)

Exclusion criteria

• Uncontrolled active variceal bleeding
• Fibrotic cord of the portal vein
• Prior history of TIPS placement or shunt surgery or endoscopic ban ligation +NSBB
• Concomitant renal insufficiency
• Severe cardiopulmonary diseases
• Uncontrolled systemic infection or sepsis
• Malignancy or other serious medical illness which may reduce the life expectancy
• Contraindications for propranolol, such as asthma, insulin-dependent diabetes (with episodes of hypoglycemia), and peripheral vascular disease
• Contraindications for heparin or warfarin
• Contraindications for TIPS

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

ET+NSBB

Active Comparator group

Description:

Endoscopic treatment(ET)- Endoscopic variceal ligation (EVL) Non-selective beta blocker(NSBB)-Propranolol. Anticoagulation(AT)- Heparin followed by warfarin.

Treatment:

Procedure: ET+NSBB

TIPS

Active Comparator group

Description:

Transjugular intrahepatic portosystemic shunt(TIPS)- TIPS.

Treatment:

Procedure: Transjugular intrahepatic portosystemic shunt (TIPS)