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A new screening strategy for varices by liver and spleen stiffness measurement (LSSM) in cirrhotic patients: A randomized trial

Liver International Sep 02, 2017

Wong GLH, et al. – This randomized trial examined whether a new screening strategy for varices guided by liver/spleen stiffness measurement (LSM and SSM) results (LSSM–guided) was non–inferior to universal endoscopic screening in detecting clinically significant varices in patients with cirrhosis. The authors concluded that by this RCT, non–inferiority of the LSSM–guided screening strategy to the conventional approach could not be excluded. This approach needed to be further assessed in a cohort of larger sample size with more clinically significant varices.

Methods
  • The authors performed a non-inferiority, open-label, randomized controlled trial.
  • They included adult patients with known chronic liver diseases, radiological evidence of liver cirrhosis and compensated liver function.
  • Clinically significant varix diagnosed with upper endoscopy was the primary outcome.

Results
  • The authors randomized 548 patients to LSSM arm (n=274) and conventional arm (n=274) between October 2013 and June 2016, which formed the intention-to-test (ITT) population.
  • In this study, patients in both study arms were predominantly middle-aged men with viral hepatitis related-cirrhosis in 85% of the cases.
  • 11 out of 274 participants in the LSSM arm (4.0%) and 16 out of 274 in the conventional arm (5.8%) were found to have clinically significant varices in the ITT analysis.
  • The difference between two groups was -1.8% (90% CI, -4.9%-1.2%, P<0.001).
  • As per the outcomes, the absolute difference in the number of patients with clinically significant varices detected was 5 out of 16 (31.3%) fewer in the LSSM arm.
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