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

Decompensated Cirrhosis Clinical Trial

Official title:

Transjugular Intrahepatic Portosystemic Shunt Versus Endoscopic Treatment Combined With Propranolol for Prevention of Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01326949
• Other study ID #: 1PVT-TIPS
• Status: Completed
• Phase: N/A
• First received: March 29, 2011
• Last updated: May 18, 2017
• Start date: May 2011
• Est. completion date: January 2016

Study information

• Verified date: May 2017
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bleeding Varices
• Decompensated Cirrhosis
• Liver Cirrhosis
• Portal Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Procedure:
• Transjugular intrahepatic portosystemic shunt (TIPS)
Transjugular intrahepatic portosystemic shunt(TIPS)- TIPS was performed in a conventional fashion or in combination of percutaneous transhepatic or transsplenic approach. Postoperatively, intravenous heparin (8,000-12,000 u/d) for five days, warfarin for six months were given.
• ET+NSBB
ET-Esophageal varices was treated by endoscopic variceal ligation (EVL). EVL was repeated at intervals of 1-2 weeks until the varices were obliterated or reduced to grade-I size. NSBB-Propranolol started at a dose of 20mg twice a day. The dose is adjusted to the maximal tolerated doses to heart rate (HR) of 55 bpm or to decrease the HR 25% from baseline. AT-A continuously intravenous infusion of unfractionated heparin followed by oral warfarin is employed. Initially, heparin is administered intravenously for 5 days. Subsequently, oral warfarin is prescribed at the dosage of 2.5 mg/d for 6 months or until complete portal vein recanalization and adjusted to maintain the INR at a target of 2.5 (range 2.0-3.0).

Locations

Country	Name	City	State
China	Xijing Hospital of Digestive Diseases, Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

Han G, Qi X, He C, Yin Z, Wang J, Xia J, Yang Z, Bai M, Meng X, Niu J, Wu K, Fan D. Transjugular intrahepatic portosystemic shunt for portal vein thrombosis with symptomatic portal hypertension in liver cirrhosis. J Hepatol. 2011 Jan;54(1):78-88. doi: 10.1016/j.jhep.2010.06.029. Epub 2010 Aug 27. — View Citation

Outcome

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