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

Not Applicable

Completed

• Conditions: Portal Vein Thrombosis; Bleeding Varices; Decompensated Cirrhosis
• Interventions: Procedure: Transjugular intrahepatic portosystemic shunt (TIPS); Procedure: ET+NSBB

• Registration Number: NCT01326949
• Lead Sponsor: Air Force Military Medical University, China

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2011-03-29
• Study First Submitted QC: 2011-03-30
• Study First Posted: 2011-03-31
• Study Start: 2011-05
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-18
• Last Update Posted: 2017-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TIPS	Transjugular intrahepatic portosystemic shunt (TIPS)	Transjugular intrahepatic portosystemic shunt(TIPS)- TIPS.
ET+NSBB	ET+NSBB	Endoscopic treatment(ET)- Endoscopic variceal ligation (EVL) Non-selective beta blocker(NSBB)-Propranolol. Anticoagulation(AT)- Heparin followed by warfarin.

Primary Outcome Measures

Name	Time	Method
Number of participants with variceal rebleeding	4 years	Variceal rebleeding is the primary endpoint of this study. Cumulative variceal rebleeding rate is compared between the two groups.

Secondary Outcome Measures

Name	Time	Method
Number of participants achieving portal vein recanalization	4 years	Portal vein recanalization is a secondary endpoint of this study. Recanalization rate of thrombosed portal vein is compared between the two groups.
Number of death	4 years	Death is a secondary endpoint of this study. Cumulative survival rate is compared between the two groups.
Changes of degree of PVT in patients without portal vein recanalization	4 years	We also observed changes of degree of portal vein thrombosis in patients without portal vein recanalization.
Number of complications	4 years	Complications include: TIPS-related complications: procedural complications, shunt dysfunction and hepatic encephalopathy.; Complications related to endoscopic and drug treatment.

Trial Locations

Locations (1)

Xijing Hospital of Digestive Diseases, Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China