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

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%, P