Spyglass直视系统及Spybite目标活检对不明原因胆道狭窄良恶性鉴别诊断价值的Meta分析

Diagnostic Value of single operator cholangioscopy and targeted biopsies for indeterminate biliary strictures Meta for analysis

摘要:

目的 系统评价Spyglass直视系统及Spybite目标活检对于不明原因胆道狭窄良恶性鉴别诊断的临床价值。 方法 计算机检索Cochrane Library、Web of Science、Scopus、Embase、Pubmed、Elsevier、Science、CNKI、Wangfang Data、VIP，收集采用Spyglass直视系统或Spybite目标活检与金标准（病理活检、尸检或长期临床随访）对不明原因胆道狭窄良恶性鉴别的诊断性试验。检索时限为从2006年1月至2017年3月，由两位研究员根据纳入及排除标准独立筛选文献，提取资料，如有异议第三位研究员参与讨论。采用QUADAS-2条目评价纳入研究的方法学质量，采用Meta-DiSc1.4软件对其敏感度（SEN）、特异度（SPE）、阳性似然比（+LR）、阴性似然比（-LR）、诊断比值比（DOR）进行异质性检验和合并分析，绘制综合受试者工作特征（SROC）曲线，计算曲线下面积（AUC）。 结果 最终纳入12个研究，532例患者参与Spyglass直视系统诊断价值研究，525例患者参与Spybite目标活检诊断价值研究。Meta分析结果显示Spyglass直视系统：SPE合并=0.90（95%CI：0.85~0.94），SEN 合并 = 0.89（95%CI：0.85~0.93），+LR合并=7.12（ 95%CI： 4.36~11.64），?LR合并=0.12（95%CI：0.07~0.22），DOR合并 =82.40（95%CI：33.73~201.28），AUC为0.957 4。Spybite目标活检：SPE合并=0.98（95%CI：0.96~1.00），SEN 合并 = 0.66（95%CI：0.60~0.71），+LR合并=13.29 （95%CI 6.92~ 25.53），?LR合并=0.37（95%CI：0.28~0.47），DOR合并 =51.05（95%CI：23.58~110.53），AUC为0.939 8。 结论 现有研究证实，Spyglass直视系统善于探测到恶性病变，Spybite目标活检在确诊恶性病变上更具优势，Spyglass直视系统与Spybite结合可作为诊断不明原因胆道狭窄有效、可行的方法，但所得阴性结果不能完全排外恶性病变。

Abstract:

Objective To systematically review the clinical value of single operator cholangioscopy and targeted biopsies for diagnosing indeterminate biliary strictures. Methods We electronically searched the databases including Cochrane Library、Web of Science、Scopus、Embase、Pubmed、Elsevier、Science、CNKI、Wangfang Data、VIP，for diagnostic tests on indeterminate biliary strictures diagnosed with single operator cholangioscopy and targeted biopsies vs. with pathological biopsy、autopsy and long term clinical follow-up (golden criteria) from January 2006 to March 2017. Two reviewers independently screened literature according to the inclusion and exclusion criteria and extracted data.Any differences were resolved by mutual agreement and in consultation with the third reviewer. The methodological quality of the included studies was assessed according to QUADAS-2 items. The Meta-DiSc software (version 1.4) was used to conduct pooling on sensitivity, specificity, positive likelihood radio, and negative likelihood radio. Heterogeneity test was performed and the summary receiver operating characteristic curve (SROC) was drawn for area under the curve (AUC). Results A total of 12 studies met the inclusion criteria,involving 532 patients who had data on single-operator peroral cholangioscopy visual impression（VI）and 525 who had data on SpyBite biopsy（SB）.The area under the curve on the summay receiver-operating characteristic curve of single-operator peroral cholangioscopy VI and SB were 0.9574 and 0.9398 respectively.The combined specificity,sensitivity,positive likelihood ratio,negative likelihood and Diagnostic OR were 0.90（95%CI：0.85~0.94）, 0.89（95%CI：0.85~0.93）, 7.12（ 95%CI： 4.36~11.64）, 0.12（95%CI：0.07~0.22）and 82.40（95%CI：33.73~201.28）for VI, and 0.98（95%CI：0.96~1.00）, 0.66（95%CI：0.60~0.71）, 13.29 （95%CI 6.92~ 25.53）, 0.37（95%CI：0.28~0.47）and51.05（95%CI：23.58~110.53）for SB, respectively. Conclusion Current evidence shows that VI is useful for detecting malignant lesion,whereas SB is better at confirming a malignant diagnosis ,which indicates single operator cholangioscopy and targeted biopsies have good diagnostic value for indetedminate biliary strictures,but their negative results are not perfect in excluding biliary cancer.