Clinical Efficacy Of Transjugular Intrahepatic Portosystemic Shunt Created With 6-mm Covered Stents For Secondary Prophylaxis Of Esophagogastric Variceal Bleeding In Patients With Cirrhosis

Background and aim: Esophagogastric variceal bleeding(EGVB)is a common complication in cirrhotic patients and a main cause of death.Transjugular Intrahepatic Portosystemic Shunt(TIPS)is one of the effective methods to prevent EGVB.However,the incidence rate of post-TIPS overt hepatic encephalopathy(OHE)is about 40% and this complication seriously influences the quality of life.In addition,OHE is one of the most important risk factors of liver failure.Liver failure and infection based on liver failure are major long-term causes of death after TIPS.The diameter of shunt largely influences the shunt flow volume,which is relevant to post-TIPS OHE.TIPS with 8mm or 10 mm covered stents has satisfying efficacy of prevention and treatment of EGVB.But most researches did not show better survival with TIPS compared to standard therapy.Liver failure and infection are the most important reasons.So decreasing the incidence of post-TIPS OHE is of great importance in improving survival rate.Choosing suitable diameter of shunt is an interesting issue concerned by researchers,nevertheless there have been few researches about TIPS with smaller diameter of covered stents than 8mm.The current research was to explore the clinical efficacy of TIPS created with 6-mm covered stents for secondary prophylaxis of Esophagogastric variceal bleeding in patients with cirrhosis and relevant complications.Methods: This was a single-center,single-blind prospective randomized controlled trial.Cirrhotic patients older than 60 years old or with Child-Turcotte-Pugh score larger than 7 who met the inclusion and exclusion criteria were enrolled.They were randomly assigned to receive TIPS with 6-mm or 8-mm covered stents to prevent variceal rebleeding.The primary endpoint was all cause rebleeding.Shunt dysfunction,EGVB,orthotopic liver transplantation-free survival and overt hepatic encephalopathy(OHE)were designated as the secondary endpoint.In terms of sample size,a total of 108 patients were needed.Patients were followed for two years or until death.The first patient was enrolled in September 2017 and in January 2019 the 50 th patient was enrolled.This were the midterm results.Results: By January 2019,a total of 50 patients were included in this study.24 and 26 patients were allocated to the 6mm and 8mm groups,respectively.There were no significant differences between the two groups except gender distribution(p=0.02)in terms of baseline characteristics.Midterm results were as followed:(1)Hemodynamic situation: Pre-TIPS portal pressure gradient(PPG)in 8mm and 6mm groups were 22.42±4.21 mmhg and 22.22±5.96 mmhg respectively,with no statistical difference(p=0.898);Post-TIPS PPG in each group were 9.34±4.76 mmhg and 11.61±4.00 mmhg respectively,with no statistical difference(p=0.085).All patients had an average PPG decrease of 59.58±17.45% and 45.34±19.62% in 8mm and 6mm group respectively with statistical difference(p=0.012).17 and 12 patients from the 8mm and 6mm groups,respectively,reached a PPG below 12 mm Hg(76.0% vs.54.5%,p=0.139).(2)During a median follow-up of 9.4 months,all cause rebleeding were not statistically different between groups(16.0% in 8mm group vs 9.1% in 6mm group,log rank p=0.493).(3)Esophagogastric variceal rebleeding were not statistically different between groups(8.0% in 8mm group vs 9.1% in 6mm group,log rank p=0.869).(4)Incidence rates of OHE were not statistically different between groups(log rank p=0.703).(5)Dysfunction rates were not statistically different between groups(12.0% in 8mm group vs 9.1% in 6mm group,log rank p=0.812).(6)OLT-free survival were not statistically different between groups(88.0%vs in 8mm group vs 95.5% in 6mm group,log rank p=0.390).Conclusions: For patients with high risk of post-TIPS OHE,decrease in PPG in TIPS with 6mm covered stents is lower than TIPS with 8mm covered stents,which didn't lead to the decrease in clinical efficacy of prevent EGVB.TIPS with 6mm covered stents tends to improve survival and reduce incidence of post-TIPS OHE.So the midterm results indicate that the research should be continued.