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Original Article
Covered TIPS versus endoscopic band ligation plus propranolol for the prevention of variceal rebleeding in cirrhotic patients with portal vein thrombosis: a randomised controlled trial
  1. Yong Lv1,
  2. Xingshun Qi1,
  3. Chuangye He1,
  4. Zhengyu Wang1,
  5. Zhanxin Yin1,
  6. Jing Niu,
  7. Wengang Guo1,
  8. Wei Bai1,
  9. Hongbo Zhang2,
  10. Huahong Xie2,
  11. Liping Yao2,
  12. Jianhong Wang3,
  13. Tao Li3,
  14. Qiuhe Wang1,
  15. Hui Chen1,
  16. Haibo Liu1,
  17. Enxing Wang1,
  18. Dongdong Xia1,
  19. Bohan Luo1,
  20. Xiaomei Li1,
  21. Jie Yuan1,
  22. Na Han1,
  23. Ying Zhu1,
  24. Jielai Xia4,
  25. Hongwei Cai4,
  26. Zhiping Yang5,
  27. Kaichun Wu5,
  28. Daiming Fan5,
  29. Guohong Han1
  30. For the PVT-TIPS Study Group.
  1. 1Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi’an, China
  2. 2Department of Digestive Endoscopy, National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi’an, China
  3. 3Department of Ultrasound, National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi’an, China
  4. 4Department of Medical Statistics, Fourth Military Medical University, Xi’an, China
  5. 5State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi’an, China
  1. Correspondence to Professor Guohong Han, Department of Liver Diseases and Digestive Interventional Radiology, Xijing Hospital of Digestive Diseases, Fourth Military Medical University, No 127 Changle West Road, Xi’an 710032 China; hangh{at}fmmu.edu.cn

Abstract

Objective Limited data are available on the prevention of variceal rebleeding in cirrhotic patients with portal vein thrombosis (PVT). This study aimed to compare transjugular intrahepatic portosystemic shunt (TIPS) with covered stents versus endoscopic band ligation (EBL) plus propranolol for the prevention of variceal rebleeding among patients with cirrhosis and PVT.

Design Consecutive cirrhotic patients (94% Child-Pugh class A or B) with PVT who had variceal bleeding in the past 6 weeks were randomly assigned to TIPS group (n=24) or EBL plus propranolol group (EBL+drug, n=25), respectively. Primary endpoint was variceal rebleeding. Secondary endpoints included survival, overt hepatic encephalopathy (OHE), portal vein recanalisation and rethrombosis, other complications of portal hypertension and adverse events.

Results During a median follow-up of 30 months in both groups, variceal rebleeding was significantly less frequent in the TIPS group (15% vs 45% at 1 year and 25% vs 50% at 2 years, respectively; HR=0.28, 95% CI 0.10 to 0.76, p=0.008), with a significantly higher portal vein recanalisation rate (95% vs 70%; p=0.03) and a relatively lower rethrombosis rate (5% vs 33%; p=0.06) compared with the EBL+drug group. There were no statistically significant differences in survival (67% vs 84%; p=0.152), OHE (25% vs 16%; p=0.440), other complications of portal hypertension and adverse events between groups.

Conclusion Covered TIPS placement in patients with PVT and moderately decompensated cirrhosis was more effective than EBL combined with propranolol for the prevention of rebleeding, with a higher probability of PVT resolution without increasing the risk of OHE and adverse effects, but this benefit did not translate into improved survival.

Trial registration number ClinicalTrials.gov: NCT01326949.

  • endoscopy
  • liver Cirrhosis
  • portal hypertension
  • venous thrombosis
  • interventional radiology
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Footnotes

  • Contributors YL: study design, data collection, evaluation of clinical events, endpoint assessment, statistical analysis, and writing and revising the manuscript. XQ: study conception and design, as well as drafting of the study hypothesis and study protocol. CH: study design, patient recruitment, informed consent, patient administration, TIPS surgery, follow-up and critical revision of the manuscript. ZW: data collection, designed the follow-up, and performed telephone follow-up and endpoint assessment. ZhanY: study design, TIPS surgery, patient administration, follow-up and critical revision of the manuscript. JN: patient randomisation, data collection and regular follow-up. WG and WB: study design and TIPS surgery. HZ, HX and LY: study design and endoscopic therapy. JW and TL: study design, percutaneous puncture of the portal vein under ultrasound-guided transhepatic and trans-splenic approaches and ultrasound follow-up of the patients. HC, QW, HL, EW, DX and ZhiY: critical revision of the manuscript. BL, XL, JY, NH and YZ: data collection. JX and HC: study design as well as design of the computer randomisation system and statistical analysis plan. KW and DF: study supervision, study design, critical revision of the manuscript and funds collection. GH: study supervision, study conception and design, patient recruitment, patient administration, TIPS surgery, follow-up, critical revision of the manuscript and funds collection. All of the authors gave their final approval of the version to be published.

  • Funding This study was supported by grants from the Optimized Overall Project of Shaanxi Province (2013KTCL03-05) and the Boost Program of Xijing Hospital (XJZT11Z07) for GH.

  • Competing interests None declared.

  • Patient consent Obtained.

  • Ethics approval Ethics committee of Xijing Hospital.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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