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- Title
A new screening strategy for varices by liver and spleen stiffness measurement (LSSM) in cirrhotic patients: A randomized trial.
- Authors
Kwok, Raymond; Tse, Yee‐Kit; Wong, Grace L. H.; Lo, Angeline O. S.; Lam, Kelvin L. Y.; Chan, Heyson C. H.; Lui, Rashid A.; Chan, Henry L. Y.; Wong, Vincent W. S.; Hui, Aric J.; Ho, Kai‐Tin; Au, Kenneth H. D.
- Abstract
Abstract: Background: Variceal bleeding is a common and life‐threatening complication in patients with cirrhosis. Screening with upper endoscopy is recommended but is uncomfortable to patients. Non‐invasive assessment with transient elastography for liver/spleen stiffness measurement (LSM and SSM) is accurate in detecting varices. Aims: To test the hypothesis that a new screening strategy for varices guided by LSM/SSM results (LSSM‐guided) is non‐inferior to universal endoscopic screening in detecting clinically significant varices in patients with cirrhosis. Methods: This was a non‐inferiority, open‐label, randomized controlled trial. Adult patients with known chronic liver diseases, radiological evidence of cirrhosis and compensated liver function. The primary outcome was clinically significant varix diagnosed with upper endoscopy. Results: Between October 2013 and June 2016, 548 patients were randomized to LSSM arm (n = 274) and conventional arm (n = 274) which formed the intention‐to‐test (ITT) population. Patients in both study arms were predominantly middle‐aged men with viral hepatitis‐related cirrhosis in 85% of the cases. In the ITT analysis, 11/274 participants in the LSSM arm (4.0%) and 16/274 in the conventional arm (5.8%) were found to have clinically significant varices. The difference between two groups was −1.8% (90% CI, −4.9% to −1.2%, <italic>P </italic><<italic> </italic>.001). The absolute difference in the number of patients with clinically significant varices detected was 5/16 (31.3%) fewer in the LSSM arm. Conclusions: Non‐inferiority of the LSSM‐guided screening strategy to the convention approach cannot be excluded by this RCT. This approach should be further evaluated in a cohort of larger sample size with more clinically significant varices.
- Subjects
CIRRHOSIS of the liver; ELASTOGRAPHY; SPLEEN diseases; LIVER; DIAGNOSIS; PATIENTS; ANATOMY
- Publication
Liver International, 2018, Vol 38, Issue 4, p636
- ISSN
1478-3223
- Publication type
Article
- DOI
10.1111/liv.13560