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

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

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.

Study Overview

• Status: Completed
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Procedure: TIPS; Procedure: Variceal Embolization

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 Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospital of Digestive Diseases, Fourth Military Medical University
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospital of digestive disease, Fourth Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TIPS combined with variceal embolization; The covered stents will be used for TIPS The gastroesophageal collaterals will be embolized during the procedure of TIPS	Procedure: TIPS; TIPS will be performed with a standard technique. TIPS revision will be planned if any evidence of shunt dysfunction is observed.; 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.
Active Comparator: TIPS alone; The covered stents will be used for TIPS No embolization of any collateral will be performed during TIPS	Procedure: TIPS; TIPS will be performed with a standard technique. TIPS revision will be planned if any evidence of shunt dysfunction is observed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All-cause rebleeding	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality	2 years
Adverse events	2 years
Variceal rebleeding	2 years
Shunt dysfunction	2 years
Hepatic encephalopathy	2 years
Liver function changs	2 years

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China
• Investigators: Principal Investigator: Guohong Han, PhD & MD, Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Publications and helpful links

General Publications

• Lv Y, Chen H, Luo B, Bai W, Li K, Wang Z, Xia D, Guo W, Wang Q, Li X, Yuan J, Cai H, Xia J, Yin Z, Fan D, Han G. Transjugular intrahepatic portosystemic shunt with or without gastro-oesophageal variceal embolisation for the prevention of variceal rebleeding: a randomised controlled trial. Lancet Gastroenterol Hepatol. 2022 Aug;7(8):736-746. doi: 10.1016/S2468-1253(22)00087-5. Epub 2022 May 17. Erratum In: Lancet Gastroenterol Hepatol. 2022 Aug;7(8):704.

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2014
• Primary Completion (Actual): November 20, 2020
• Study Completion (Actual): November 20, 2020

Study Registration Dates

• First Submitted: April 17, 2014
• First Submitted That Met QC Criteria: April 18, 2014
• First Posted (Estimate): April 22, 2014

Study Record Updates

• Last Update Posted (Actual): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 22, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: TIPS; Embolization; Variceal rebleeding
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: TIPS-Variceal embolization