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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-16

Study Completion Date

2020-11-20

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.

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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.

Conditions

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Liver Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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TIPS combined with variceal embolization

The covered stents will be used for TIPS

The gastroesophageal collaterals will be embolized during the procedure of TIPS

Group Type EXPERIMENTAL

TIPS

Intervention Type PROCEDURE

TIPS will be performed with a standard technique. TIPS revision will be planned if any evidence of shunt dysfunction is observed.

Variceal Embolization

Intervention Type PROCEDURE

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.

TIPS alone

The covered stents will be used for TIPS

No embolization of any collateral will be performed during TIPS

Group Type ACTIVE_COMPARATOR

TIPS

Intervention Type PROCEDURE

TIPS will be performed with a standard technique. TIPS revision will be planned if any evidence of shunt dysfunction is observed.

Interventions

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TIPS

TIPS will be performed with a standard technique. TIPS revision will be planned if any evidence of shunt dysfunction is observed.

Intervention Type PROCEDURE

Variceal 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.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No