Clinical efficacy of transjugular intrahepatic portosystemic shunt created with covered stents with different diameters: results of a randomized controlled trial

J Hepatol. 2010 Aug;53(2):267-72. doi: 10.1016/j.jhep.2010.02.033. Epub 2010 Apr 27.

Abstract

Background & aims: The incidence of post-TIPS hepatic encephalopathy (HE) could be reduced by using stents with a small diameter. The aim of this study was to compare the incidence of HE and the clinical efficacy of TIPS created with 8- or 10-mm PTFE-covered stents.

Methods: Consecutive cirrhotics submitted to TIPS for variceal bleeding or refractory ascites were randomized to receive a 8- or 10-mm covered stent. As recommended by our Ethical Committee, the trial was stopped after the inclusion of 45 patients.

Results: The two groups were comparable for age, sex, etiology, and psychometric performance. After TIPS, the portosystemic pressure gradient was significantly higher in the 8-mm stent group (8.9+/-2.7 versus 6.5+/-2.7 mmHg; p=0.007). Consequently, the probability of remaining free of complications due to portal hypertension was significantly higher in the 10-mm than in the 8-mm stent group: 82.9% versus 41.9% at one year; log-rank test, p=0.002. In particular, the persistence of ascites with the need for repeated paracentesis was significantly more frequent in the patients treated with 8-mm stent diameter for refractory ascites (log-rank test, p=0.008). The probability of remaining free of HE was similar in both groups. Cumulative survival rate was similar in both groups.

Conclusions: The use of 8-mm diameter stents for TIPS leads to a significantly less efficient control of complications of portal hypertension. HE remains an unsolved major problem after TIPS.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Ascites / etiology
  • Ascites / therapy
  • Female
  • Hepatic Encephalopathy / epidemiology
  • Hepatic Encephalopathy / etiology
  • Hepatic Encephalopathy / prevention & control*
  • Humans
  • Hypertension, Portal / complications
  • Hypertension, Portal / mortality
  • Hypertension, Portal / surgery*
  • Incidence
  • Liver Cirrhosis / complications
  • Liver Cirrhosis / mortality
  • Liver Cirrhosis / surgery*
  • Male
  • Middle Aged
  • Paracentesis
  • Portasystemic Shunt, Transjugular Intrahepatic / adverse effects*
  • Portasystemic Shunt, Transjugular Intrahepatic / instrumentation*
  • Portasystemic Shunt, Transjugular Intrahepatic / methods
  • Psychometrics
  • Stents*
  • Survival Rate
  • Treatment Outcome