肝硬化患者肝脏和脾脏硬度测量（LSSM）新的静脉曲张筛查策

StephenW

A new screening strategy for varices by liver and spleen stiffness measurement (LSSM) in cirrhotic patients: A randomized trial
Grace L. H. Wong
Raymond Kwok
Aric J. Hui
Yee‐Kit Tse
Kai‐Tin Ho
Angeline O. S. Lo
Kelvin L. Y. Lam
Heyson C. H. Chan
Rashid A. Lui
Kenneth H. D. Au
... See all authors
First published: 29 August 2017
https://doi.org/10.1111/liv.13560
Cited by: 1

Funding InformationThis work was supported by the Health and Medical Research Fund from ... More

Handling Editor: Christophe Bureau

Trial registration: https://clinicaltrials.gov/ct2/show/NCT02024347; ClinicalTrials.gov: NCT02024347

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%, 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.
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.

StephenW

肝硬化患者肝脏和脾脏硬度测量（LSSM）新的静脉曲张筛查策略：一项随机试验
Grace L. H. Wong
Raymond Kwok
Aric J. Hui
谢谢谢谢
何启天
Angeline O. Lo
Kelvin L. Y. Lam
Heyson C. H. Chan
Rashid A. Lui
Kenneth H. D. Au
...查看所有作者
首次发布：2017年8月29日
https://doi.org/10.1111/liv.13560
引用者：1

资金信息这项工作得到了卫生和医学研究基金的支持...更多

处理编辑：克里斯托夫局

试用注册：https：//clinicaltrials.gov/ct2/show/NCT02024347; ClinicalTrials.gov：NCT02024347

抽象
背景

静脉曲张出血是肝硬化患者常见并危及生命的并发症。建议使用上消化道内镜筛查，但患者不舒服。使用瞬态弹性成像进行肝脏/脾脏刚度测量（LSM和SSM）的非侵入性评估在检测静脉曲张方面是准确的。
目标

为了验证LSM / SSM结果（LSSM引导）指导下的新型静脉曲张筛查策略并非劣于通用内镜筛查在检测肝硬化患者临床显着静脉曲张方面的假设。
方法

这是一项非劣效性开放标签随机对照试验。已知慢性肝病的成人患者，肝硬化和代偿性肝功能的放射学证据。主要结果是临床上显着的varix诊断为上消化道内镜检查。
结果

在2013年10月至2016年6月期间，548名患者被随机分配到形成意向测试（ITT）人群的LSSM组（n = 274）和常规组（n = 274）。在85％的病例中，两个研究组中的患者主要都是中年男性，并伴有病毒性肝炎相关的肝硬化。在ITT分析中，LSSM组11/274名受试者（4.0％）和常规组16/274（5.8％）被发现有临床显着静脉曲张。两组之间的差异为-1.8％（90％CI，-4.9％至-1.2％，P <0.001）。临床显着静脉曲张患者数量的绝对差异在LSSM组中减少了5/16（31.3％）。
结论

本RCT不能排除LSSM指导的筛查策略对于公约方法的不利影响。这种方法应该在更大样本量的队列中进一步评估，临床显着的静脉曲张更多。

桦子

摘要
目的
使用瞬时弹性成像技术测量肝脾脏硬度，联合门静脉宽度评估肝硬化患者食管胃底静脉曲张出血风险。

请教StephenW:
LSM、SSM与重度静脉扩张（EV）之间均存在正相关, LSM、SSM诊断重度静脉扩展（EV）的界值分别为23.4 kPa，40.3 kPa。
目前SSM 脾脏硬度检查好像医院里没有这个项目？
谢谢！

桦子

回复 桦子 的帖子

弄错了，重新发。
请教StephenW:
LSM、SSM与重度静脉扩张（EV）之间均存在正相关, LSM、SSM诊断重度静脉扩展（EV）的界值分别为23.4 kPa，40.3 kPa。
目前SSM 脾脏硬度检查好像医院里没有这个项目？
谢谢！

StephenW

回复 桦子 的帖子

感谢您提供临床试验的知料.
LSSM arm
Intervention: upper endoscopy only performed to patients with high LSM (≥12.0kPa) or SSM (≥41.3kPa) values
Control arm
Intervention: upper endoscopy performed to all patients in this group.
LSSM组
干预：仅对LSM高（≥12.0kPa）或SSM（≥41.3kPa）值的患者进行上消化道内镜检查
控制组(常规组)
干预：对本组所有患者进行上消化道内镜检查。

容易理解以上临床的结果.

目前SSM 脾脏硬度检查好像医院里没有这个项目？是, 我同意. 看起来Fibroscan机器也可以测量脾脏僵硬度. 不知道如何?.