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The influence of shunting left/right portal vein branch on post-TIPS hepatic encephalopathy: a study protocol for
Jingqin Ma1,2,3, Jianjun Luo4,5,6,7, Wen Zhang1,2,3
1Department of Interventional Radiology, Zhongshan Hospital, Fudan University, Shanghai, China.
Insights
This study compares transjugular intrahepatic portosystemic shunt (TIPS) in patients with hepatitis B virus (HBV) cirrhosis, finding the portal vein branch choice impacts hepatic encephalopathy (HE) rates. Results guide safer TIPS procedures for preventing gastroesophageal varices rebleeding.
Area of Science:
- Hepatology
- Interventional Radiology
- Gastroenterology
Background:
- Gastroesophageal varices (GOV) bleeding is a severe complication of advanced liver cirrhosis.
- Transjugular intrahepatic portosystemic shunt (TIPS) is crucial for managing acute variceal hemorrhage and preventing rebleeding.
- Hepatic encephalopathy (HE) post-TIPS, occurring in 10-50% of patients, limits its widespread application.
Purpose of the Study:
- To compare the incidence of hepatic encephalopathy (HE) after TIPS between patients with hepatitis B virus (HBV)-related cirrhosis undergoing left versus right portal vein branch shunting.
- To evaluate secondary outcomes including HE grade and duration, shunt dysfunction, rebleeding rates, HE-free survival, stent patency, and overall survival.
Main Methods:
- A multicenter randomized controlled trial involving 130 patients with HBV-related cirrhosis.
- Patients were randomized 1:1 to receive an 8-mm Viatorr stent TIPS procedure targeting either the left or right portal vein branch.
- Primary endpoint: incidence of post-TIPS HE. Secondary endpoints: HE severity, duration, rebleeding, shunt dysfunction, and survival rates at 12 and 24 months.
Main Results:
- The study is ongoing, with 55 patients recruited to date (27 in the left group, 28 in the right group).
- Interim analysis of recruited patients is pending to compare HE incidence and secondary outcomes between the two groups.
Conclusions:
- The choice of portal vein branch for TIPS may influence the incidence and severity of hepatic encephalopathy in patients with HBV-related cirrhosis.
- Further results are needed to determine optimal TIPS strategy for minimizing HE while effectively preventing variceal rebleeding.
Introduction:
Gastroesophageal varices (GOV) bleeding is a common and serious complication of advanced liver cirrhosis with a median survival of less than 2 years. Multiple guidelines have pointed out that transjugular intrahepatic portosystemic shunt (TIPS) is the rescue treatment of acute variceal hemorrhage (AVB) after failure of standard therapy and an effective second-line treatment for preventing patients with high risks from rebleeding of GOV. The safety and stability of TIPS have been greatly improved due to the improvements of related technologies and the emergence of various novel devices, but the incidence of hepatic encephalopathy (HE) after shunting (10-50%) hindered the widespread use of TIPS. The target portal vein branch might affect the incidence of HE after TIPS. The aim of this study is to compare the rate of HE in patients with hepatitis B virus (HBV) related cirrhosis receiving TIPS either the left or right branch of the portal vein with 8mm Viatorr stent for preventing rebleeding from GOV.
Methods And Analysis:
This study is a multicenter randomized controlled trial comparing the influence of shunting left or right portal vein branch on post-TIPS hepatic encephalopathy for preventing rebleeding from GOV in patients with HBV-related cirrhosis. A total of 130 patients will be recruited over a period of 24 months across 5 centers in China. Eligible patients will be stratified 1:1 to constructing either a left or right portal vein shunt with an 8-mm Viatorr stent. The primary objective was to compare the incidence of post-TIPS hepatic encephalopathy between the two groups. The secondary objectives were to compare the grade and duration of hepatic encephalopathy, the rate of shunt dysfunction, the rate of variceal rebleeding, the HE-free survival, the cumulative patency rate of the stent, and the overall survival at 12 months and 24 months between two groups.
Ethics And Dissemination:
This study was approved by the ethics committee of Zhongshan Hospital of Fudan University (No. B2018-292R) and was registered at ClinicalTrials.gov (NCT03825848). All participants give written informed consent.
Trial Registration:
ClinicalTrials.gov NCT03825848. Registered on January 31, 2019 TRIAL STATUS: The first patient was recruited into our study on June 19, 2019. A total of 55 patients were recruited till May 27, 2021 (27 and 28 patients assigned to shunting the left (L Group) and right (R Group) branches of the portal vein, respectively).
