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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guohong Han, Fourth Military Medical University
ClinicalTrials.gov Identifier:
NCT01326949
First received: March 29, 2011
Last updated: May 18, 2017
Last verified: May 2017
  Purpose

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 Intervention
Decompensated Cirrhosis Portal Vein Thrombosis Bleeding Varices Procedure: Transjugular intrahepatic portosystemic shunt (TIPS) Procedure: ET+NSBB

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Guohong Han, Fourth Military Medical University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

    Complications include:

    TIPS-related complications: procedural complications, shunt dysfunction and hepatic encephalopathy.

    Complications related to endoscopic and drug treatment.



Enrollment: 52
Study Start Date: May 2011
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ET+NSBB

Endoscopic treatment(ET)- Endoscopic variceal ligation (EVL)

Non-selective beta blocker(NSBB)-Propranolol.

Anticoagulation(AT)- Heparin followed by warfarin.

Procedure: 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).

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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326949

Locations
China, Shaanxi
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Fourth Military Medical University
Investigators
Principal Investigator: Guohong Han Xijing Hospital of Digestive Diseases, Fourth Military Medical University
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Guohong Han, Head of Department of Digestive Interventional Radiology, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT01326949     History of Changes
Other Study ID Numbers: 1PVT-TIPS
Study First Received: March 29, 2011
Last Updated: May 18, 2017

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Liver Cirrhosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases
Heparin
Warfarin
Propranolol
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on September 19, 2017