TIPS Combined With Variceal Embolization for the Prevention of Variceal Rebleeding in Patients With Cirrhosis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether TIPS combined with variceal embolization are effective in the prevention of variceal rebleeding in patients with liver cirrhosis.

Detailed Description
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Variceal bleeding is one of the leading causes of death in patients with cirrhosis. Patients with cirrhosis surviving a variceal bleeding are at high risk of rebleeding (over 60% at 1 year), and mortality from each rebleeding episode is about 20%. Placement of TIPS is a well-established technique that is highly effective in preventing recurrent variceal bleeding, especially if the TIPS is created with an expanded polytetrafluoroethylene (ePTFE)-covered stent, which has a significantly lower risk of shunt dysfunction than does TIPS created with bare stents. But the risk of hepatic encephalopathy greatly increases and the risk of recurrent variceal bleeding after TIPS placement remains an issue. Besides an insufficient decrease in portosystemic pressure gradient after TIPS creation alone, fragile variceal vessels also are considered a risk factor for recurrent bleeding. Accordingly, TIPS combined with variceal embolization has been advocated to achieve the best result possible in preventing recurrent variceal bleeding. However, in recent American Association of the Study of Liver Disease (AASLD) practice guidelines and Baveno V consensus, no treatment strategies were clearly recommended maybe because the exact efficacy of this strategy remains unclear and high-quality randomized controlled trials still lacks. So the investigators hypothesized that embolization of these collateral vessels may increase the blood flow within the shunt and into the liver, which can theoretically decrease the incidence of shunt dysfunction and encephalopathy, even can prolong the patients' survival.

Official Title
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Transjugular Intrahepatic Portosystemic Shunt (TIPS) Using Covered Stents Combined With Variceal Embolization in the Prevention of Variceal Rebleeding for Patients With Cirrhosis : a Prospective, Open-labeled, Randomized, Controlled Trial

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Procedure: TIPS
* Procedure: Variceal Embolization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed written informed consent Dignosis of cirrhosis (clinical or by liver biopsy) Admission due to variceal bleeding occurred 5 to 42 days prior and standard treatment for secondary prophylaxis failed Age 18 to 75 years Exclusion Criteria: Hepatic carcinoma and/or other malignancy diseases Portal vein thrombosis (≥50% of the lumen) Child-Pugh score>13 points Spontaneous recurrent hepatic encephalopathy Budd-Chiari syndrome Large spontaneous portosystemic shunts Sepsis Spontaneous bacterial peritonitis Uncontrollable hypertension Serious cardiac or pulmonary dysfunction Renal failure With TIPS contraindications Previous TIPS or collateral embolization, Pregnancy or breast-feeding History of organ transplantation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TIPS combined with variceal embolization<br>The covered stents will be used for TIPS The gastroesophageal collaterals will be embolized during the procedure of TIPS | Procedure: TIPS<br>* TIPS will be performed with a standard technique. TIPS revision will be planned if any evidence of shunt dysfunction is observed.<br>Procedure: Variceal Embolization<br>* Embolization of gastroesophageal collaterals will be conducted via the same jugular vein before TIPS implantation. The major procedures includ (a) angiography of gastroesophageal collaterals after successful intrahepatic puncture of a branch of the portal vein and (b) embolization of gastroesophageal collaterals with coils of varying diameters, which result in the gastroesophageal collaterals disappearing at postembolization angiography.<br>|
| Active Comparator: TIPS alone<br>The covered stents will be used for TIPS No embolization of any collateral will be performed during TIPS | Procedure: TIPS<br>* TIPS will be performed with a standard technique. TIPS revision will be planned if any evidence of shunt dysfunction is observed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause rebleeding |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variceal rebleeding |  | 2 years | 
| Shunt dysfunction |  | 2 years | 
| Hepatic encephalopathy |  | 2 years | 
| Liver function changs |  | 2 years | 
| Mortality |  | 2 years | 
| Adverse events |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TIPS, Embolization, Variceal rebleeding