Portal Vein Thrombosis 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
Verified date | May 2017 |
Source | Fourth Military Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Xijing Hospital of Digestive Diseases, Fourth Military Medical University | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
Fourth Military Medical University |
China,
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
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 |
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