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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
Sponsor:
Information provided by (Responsible Party):
Guohong Han, Air Force Military Medical University, China

Tracking Information
First Submitted Date  ICMJE March 29, 2011
First Posted Date  ICMJE March 31, 2011
Last Update Posted Date May 19, 2017
Study Start Date  ICMJE May 2011
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2011)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Prevention of Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Decompensated Cirrhosis
  • Portal Vein Thrombosis
  • Bleeding Varices
Intervention  ICMJE
  • 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.
  • 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).

Study Arms  ICMJE
  • Active Comparator: ET+NSBB

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

    Non-selective beta blocker(NSBB)-Propranolol.

    Anticoagulation(AT)- Heparin followed by warfarin.

    Intervention: Procedure: ET+NSBB
  • Active Comparator: TIPS
    Transjugular intrahepatic portosystemic shunt(TIPS)- TIPS.
    Intervention: Procedure: Transjugular intrahepatic portosystemic shunt (TIPS)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2015)
52
Original Estimated Enrollment  ICMJE
 (submitted: March 30, 2011)
50
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01326949
Other Study ID Numbers  ICMJE 1PVT-TIPS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Guohong Han, Air Force Military Medical University, China
Study Sponsor  ICMJE Air Force Military Medical University, China
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Guohong Han Xijing Hospital of Digestive Diseases, Fourth Military Medical University
PRS Account Air Force Military Medical University, China
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP