Liver Cirrhosis
Conditions
Keywords
TIPS, Embolization, Variceal rebleeding
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.
Interventions
PROCEDURETIPS
TIPS will be performed with a standard technique. TIPS revision will be planned if any evidence of shunt dysfunction is observed.
PROCEDUREVariceal Embolization
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.
Sponsors
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause rebleeding | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Shunt dysfunction | 2 years |
| Hepatic encephalopathy | 2 years |
| Variceal rebleeding | 2 years |
| Mortality | 2 years |
| Adverse events | 2 years |
| Liver function changs | 2 years |
Countries
China
Outcome results
None listed