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

Not Applicable

Completed

• Conditions: Liver Cirrhosis
• Interventions: Procedure: TIPS; Procedure: Variceal Embolization

• Registration Number: NCT02119988
• Lead Sponsor: Air Force Military Medical University, China

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.

Study Timeline

• Study First Submitted: 2014-04-17
• Study First Submitted QC: 2014-04-18
• Study First Posted: 2014-04-22
• Study Start: 2014-06-16
• Primary Completion: 2020-11-20
• Study Completion: 2020-11-20
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-22
• Last Update Posted: 2022-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TIPS combined with variceal embolization	TIPS	The covered stents will be used for TIPS The gastroesophageal collaterals will be embolized during the procedure of TIPS
TIPS alone	TIPS	The covered stents will be used for TIPS No embolization of any collateral will be performed during TIPS
TIPS combined with variceal embolization	Variceal Embolization	The covered stents will be used for TIPS The gastroesophageal collaterals will be embolized during the procedure of TIPS

Primary Outcome Measures

Name	Time	Method
All-cause rebleeding	2 years

Secondary Outcome Measures

Name	Time	Method
Hepatic encephalopathy	2 years
Variceal rebleeding	2 years
Liver function changs	2 years
Adverse events	2 years
Shunt dysfunction	2 years
Mortality	2 years

Trial Locations

Locations (2)

Xijing Hospital of digestive disease, Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China

Xijing Hospital of Digestive Diseases, Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China