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

AimsTo 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.

MethodsThis 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.

ResultsBetween 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%, P<.001). The absolute difference in the number of patients with clinically significant varices detected was 5/16 (31.3%) fewer in the LSSM arm.

ConclusionsNon-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.
All Author(s) ListWong GLH, Kwok R, Hui AJ, Tse YK, Ho KT, Lo AOS, Lam KLY, Chan HCH, Lui RA, Au KHD, Chan HLY, Wong VWS
Journal nameLiver International
Year2018
Month4
Volume Number38
Issue Number4
PublisherWILEY
Pages636 - 644
ISSN1478-3223
eISSN1478-3231
LanguagesEnglish-United Kingdom
Keywordscirrhosis, liver and spleen stiffness measurement, transient elastography, variceal bleeding
Web of Science Subject CategoriesGastroenterology & Hepatology;Gastroenterology & Hepatology

Last updated on 2020-07-07 at 01:15