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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Liver Cirrhosis
- Sponsor
- Air Force Military Medical University, China
- Enrollment
- 134
- Locations
- 2
- Primary Endpoint
- All-cause rebleeding
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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.
Investigators
Guohong Han
M.D., Ph.D.
Air Force Military Medical University, China
Eligibility Criteria
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
- •Spontaneous bacterial peritonitis
- •Uncontrollable hypertension
- •Serious cardiac or pulmonary dysfunction
- •Renal failure
Outcomes
Primary Outcomes
All-cause rebleeding
Time Frame: 2 years
Secondary Outcomes
- Hepatic encephalopathy(2 years)
- Variceal rebleeding(2 years)
- Liver function changs(2 years)
- Adverse events(2 years)
- Shunt dysfunction(2 years)
- Mortality(2 years)