Transjugular intrahepatic portosystemic shunt with or without gastro-oesophageal variceal embolisation for the prevention of variceal rebleeding: a randomised controlled trial,The Lancet Gastroenterology & Hepatology

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Transjugular intrahepatic portosystemic shunt with or without gastro-oesophageal variceal embolisation for the prevention of variceal rebleeding: a randomised controlled trial
The Lancet Gastroenterology & Hepatology ( IF 35.7 ) Pub Date : 2022-05-17 , DOI: 10.1016/s2468-1253(22)00087-5
Yong Lv ₁ , Hui Chen ₂ , Bohan Luo ₃ , Wei Bai ₃ , Kai Li ₂ , Zhengyu Wang ₃ , Dongdong Xia ₃ , Wengang Guo ₃ , Qiuhe Wang ₂ , Xiaomei Li ₃ , Jie Yuan ₃ , Hongwei Cai ₄ , Jielai Xia ₅ , Zhanxin Yin ₃ , Daiming Fan ₆ , Guohong Han ₃

Affiliation

Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China; Military Medical Innovation Center, Fourth Military Medical University, Xi'an, China.
Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.
Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China; Department of Liver Diseases and Interventional Radiology, Digestive Diseases Hospital, Xi'an International Medical Center Hospital, Northwest University, Xi'an, China.
Department of Technology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Department of Medical Statistics, School of Preventive Medicine, Fourth Military Medical University, Xi'an, China.
State Key Laboratory of Cancer Biology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.

Background

The role of variceal embolisation at the time of transjugular intrahepatic portosystemic shunt (TIPS) creation for the prevention of gastro-oesophageal variceal rebleeding remains controversial. This study aimed to evaluate whether adding variceal embolisation to TIPS placement could reduce the incidence of rebleeding after TIPS in patients with cirrhosis.

Methods

We did an open-label, randomised controlled trial at one university hospital in China. Eligible patients were aged 18–75 years with cirrhosis and had variceal bleeding in the past 6 weeks, and they were randomly assigned (1:1) to receive TIPS (with a covered stent in both groups) plus variceal embolisation (TIPS plus embolisation group) or TIPS alone (TIPS group) to prevent variceal rebleeding. Randomisation was done using a web-based randomisation system using a Pocock and Simon's minimisation method, stratified by Child-Pugh class (A vs B vs C). Clinicians and patients were not masked to treatment allocation; individuals involved in data analysis were masked to treatment assignment. The primary endpoint was the 2-year cumulative incidence of variceal rebleeding after randomisation, and analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, NCT02119988.

Findings

Between June 16, 2014, and Feb 3, 2016, 205 patients were screened, of whom 134 were randomly allocated to the TIPS plus embolisation group (n=69) and the TIPS group (n=65). TIPS placement and variceal embolisation was successful in all 134 patients, all were included in the analysis. There was no significant difference in the 2-year cumulative incidence of variceal rebleeding between the two groups (TIPS plus embolisation 11·6% [95% CI 4·0–19·1] vs TIPS 13·8% [5·4–22·2]; hazard ratio 0·82 [95% CI 0·42–1·61]; p=0·566). Adverse events were similar between the two groups; the most common adverse events were peptic ulcer or gastritis (12 [17%] of patients in the TIPS plus embolisation group vs 13 [20%] of patients in the TIPS group), new or worsening ascites (ten [14%] vs six [9%]), and hepatocellular carcinoma (four [6%] vs six [9%]). The numbers of deaths were also similar between groups (24 [35%] vs 25 [38%])

Interpretation

Adding variceal embolisation to TIPS did not significantly reduce the incidence of variceal rebleeding in patients with cirrhosis. Our findings do not support concomitant variceal embolisation during TIPS for the prevention of variceal rebleeding.