Yan Hualin, Du Lanxin, Zhou Jiaojiao, Li Yan, Lei Jing, Liu Juxian, Luo Yan
Department of Medical Ultrasound, West China Hospital, Sichuan University, Chengdu, China.
Department of Ultrasound, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
BMJ Open. 2021 Feb 11;11(2):e042129. doi: 10.1136/bmjopen-2020-042129.
Biliary atresia (BA) is a life-threatening disease with persistent neonatal cholestasis and progressive liver fibrosis. Timely non-invasive diagnosis of BA can result in early hepatic portoenterostomy (HPE) and better prognosis. Quantitative elastography enables the non-invasive measurement of liver stiffness. However, the studies on elastography methods in the diagnosis of BA and the prediction of post-HPE outcomes vary in their results and have small sample sizes. Thus, we propose this systematic review and meta-analysis to obtain comprehensive evidence on the value of elastography in BA.
We will search the PubMed, Embase and the Cochrane Central Register of Controlled Trials databases for studies evaluating the diagnostic performance of elastography in patients with BA and the prognostic value of postoperative elastography, from inception to 31 December 2020. We plan to use the Quality Assessment of Diagnostic Accuracy Studies-2 list and the Quality In Prognosis Studies tool to assess the risk of bias in the included studies and the study quality. We will evaluate the diagnostic performance of elastography by synthesising the pooled sensitivity, pooled specificity, pooled positive likelihood ratio, pooled negative likelihood ratio, pooled diagnostic OR and summary receiver operating characteristic curve using Meta-Disc V.1.4. We will evaluate the predictive value of elastography after HPE by synthesising the pooled correlation coefficient and pooled OR of prognostic outcomes using STATA V.14. The funnel plot and Egger's test will be used to evaluate the potential publication bias. Sensitivity analysis will be conducted by examining the estimated effects of individual studies.
As this study is a meta-analysis based on previously published literature, ethical approval is not necessary according to the ethics committee of West China Hospital, Sichuan University. The results of this study will be published in a peer-reviewed journal.
CRD42020162055.
胆道闭锁（BA）是一种危及生命的疾病，伴有持续性新生儿胆汁淤积和进行性肝纤维化。及时进行无创诊断BA可实现早期肝门肠吻合术（HPE）并获得更好的预后。定量弹性成像能够无创测量肝脏硬度。然而，关于弹性成像方法在BA诊断及HPE术后预后预测方面的研究结果各异且样本量较小。因此，我们开展本系统评价和荟萃分析以获取弹性成像在BA中价值的全面证据。
我们将检索PubMed、Embase和Cochrane对照试验中央注册库数据库，以查找评估弹性成像在BA患者中的诊断性能及术后弹性成像预后价值的研究，检索时间范围为建库至2020年12月31日。我们计划使用诊断准确性研究质量评估-2清单和预后研究质量工具来评估纳入研究中的偏倚风险和研究质量。我们将使用Meta-Disc V.1.4通过综合合并敏感度、合并特异度、合并阳性似然比、合并阴性似然比、合并诊断比值比和汇总接受者操作特征曲线来评估弹性成像的诊断性能。我们将使用STATA V.14通过综合合并相关系数和预后结局的合并比值比来评估HPE后弹性成像的预测价值。漏斗图和Egger检验将用于评估潜在的发表偏倚。将通过检查个体研究的估计效应进行敏感性分析进行敏感性分析。
由于本研究是基于既往发表文献的荟萃分析，根据四川大学华西医院伦理委员会的规定无需伦理批准。本研究结果将发表在同行评审期刊上。
PROSPERO注册号：CRD42020162055。
