Clinical trial NCT02119988: TIPS Combined With Variceal Embolization for the Prevention of Variceal Rebleeding in Patients With Cirrhosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cirrhosis
Keywords: TIPS
Embolization
Variceal rebleeding
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2014-04-22
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: All-cause rebleeding
timeFrame: 2 years
Secondary outcomes:
measure: Variceal rebleeding
timeFrame: 2 years
measure: Shunt dysfunction
timeFrame: 2 years
measure: Hepatic encephalopathy
timeFrame: 2 years
measure: Liver function changs
timeFrame: 2 years
measure: Mortality
timeFrame: 2 years
measure: Adverse events
timeFrame: 2 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of digestive disease, Fourth Military Medical University
state: Shaanxi
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases, Fourth Military Medical University
state: Shaanxi
Study officials:
affiliation: Xijing Hospital of Digestive Diseases, Fourth Military Medical University
name: Guohong Han, PhD & MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.