Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, Hong Kong.
Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, Hong Kong.
Liver Int. 2018 Apr;38(4):636-644. doi: 10.1111/liv.13560. Epub 2017 Sep 10.
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.
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.
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.
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 < .001). The absolute difference in the number of patients with clinically significant varices detected was 5/16 (31.3%) fewer in the LSSM arm.
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.
静脉曲张出血是肝硬化患者常见且危及生命的并发症。推荐对其进行上内窥镜检查筛查，但患者对此感到不适。肝脏/脾脏硬度测量的瞬时弹性成像（LSM 和 SSM）等非侵入性评估方法在检测静脉曲张方面具有较高的准确性。
本研究旨在检验以下假设，即基于 LSM/SSM 结果（LSSM 指导）的新静脉曲张筛查策略在检测肝硬化患者的临床显著静脉曲张方面不劣于普遍的内镜筛查。
这是一项非劣效性、开放性、随机对照试验。纳入患有已知慢性肝病、影像学证据为肝硬化且肝功能代偿的成年患者。主要结局为通过上内窥镜诊断的临床显著静脉曲张。
2013 年 10 月至 2016 年 6 月，548 例患者被随机分配至 LSSM 组（n=274）和常规组（n=274），这两组形成了意向治疗（ITT）人群。在这两组患者中，均以中年男性为主，85%的患者为病毒性肝炎相关的肝硬化。在 ITT 分析中，LSSM 组 274 例患者中有 11 例（4.0%）和常规组 274 例患者中有 16 例（5.8%）被发现存在临床显著静脉曲张。两组之间的差异为-1.8%（90%CI，-4.9%至-1.2%，P<.001）。LSSM 组中检测到的临床显著静脉曲张患者数量绝对减少了 5/16（31.3%）。
本 RCT 不能排除 LSSM 指导的筛查策略与传统方法相比不劣效。这种方法应该在更大样本量的队列中进行进一步评估，以纳入更多的临床显著静脉曲张患者。
