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

Air Force Military Medical University of People's Liberation Army

Status: Completed

Conditions: Liver Cirrhosis

Treatments: Procedure: TIPS; Procedure: Variceal Embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT02119988

TIPS-Variceal embolization

Details and patient eligibility

About

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.

Full 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.

Enrollment: 134 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

TIPS combined with variceal embolization

Experimental group

Description:

The covered stents will be used for TIPS The gastroesophageal collaterals will be embolized during the procedure of TIPS

Treatment:

Procedure: Variceal Embolization

Procedure: TIPS

TIPS alone

Active Comparator group

Description:

The covered stents will be used for TIPS No embolization of any collateral will be performed during TIPS

Treatment:

Procedure: TIPS