Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Prevention of Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis
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|ClinicalTrials.gov Identifier: NCT01326949|
Recruitment Status : Completed
First Posted : March 31, 2011
Last Update Posted : May 19, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Decompensated Cirrhosis Portal Vein Thrombosis Bleeding Varices||Procedure: Transjugular intrahepatic portosystemic shunt (TIPS) Procedure: ET+NSBB||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Active Comparator: ET+NSBB
Endoscopic treatment(ET)- Endoscopic variceal ligation (EVL)
Non-selective beta blocker(NSBB)-Propranolol.
Anticoagulation(AT)- Heparin followed by warfarin.
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).
Active Comparator: TIPS
Transjugular intrahepatic portosystemic shunt(TIPS)- TIPS.
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.
- Number of participants with variceal rebleeding [ Time Frame: 4 years ]Variceal rebleeding is the primary endpoint of this study. Cumulative variceal rebleeding rate is compared between the two groups.
- Number of death [ Time Frame: 4 years ]Death is a secondary endpoint of this study. Cumulative survival rate is compared between the two groups.
- Number of participants achieving portal vein recanalization [ Time Frame: 4 years ]Portal vein recanalization is a secondary endpoint of this study. Recanalization rate of thrombosed portal vein is compared between the two groups.
- Changes of degree of PVT in patients without portal vein recanalization [ Time Frame: 4 years ]We also observed changes of degree of portal vein thrombosis in patients without portal vein recanalization.
- Number of complications [ Time Frame: 4 years ]
TIPS-related complications: procedural complications, shunt dysfunction and hepatic encephalopathy.
Complications related to endoscopic and drug treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01326949
|Xijing Hospital of Digestive Diseases, Fourth Military Medical University|
|Xi'an, Shaanxi, China, 710032|
|Principal Investigator:||Guohong Han||Xijing Hospital of Digestive Diseases, Fourth Military Medical University|