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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02119988
• Other study ID #: TIPS-Variceal embolization
• Status: Completed
• Phase: N/A
• Start date: June 16, 2014
• Est. completion date: November 20, 2020

Study information

• Verified date: October 2022
• Source: Air Force Military Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: November 20, 2020
• Est. primary completion date: November 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis

Intervention

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

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Air Force Military Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause rebleeding		2 years
Secondary	Variceal rebleeding		2 years
Secondary	Shunt dysfunction		2 years
Secondary	Hepatic encephalopathy		2 years
Secondary	Liver function changs		2 years
Secondary	Mortality		2 years
Secondary	Adverse events		2 years