基于探头的共聚焦激光显微内镜术对不确定胆管狭窄特征诊断准确性的验证：一项前瞻性多中心国际研究的结果

Validation of the diagnostic accuracy of probe-based confocal laser endomicroscopy for the characterization of indeterminate biliary strictures: results of a prospective multicenter international study.

作者信息

Slivka Adam, Gan Ian, Jamidar Priya, Costamagna Guido, Cesaro Paola, Giovannini Marc, Caillol Fabrice, Kahaleh Michel

机构信息

Division of Gastroenterology, Hepatology & Nutrition, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.

Digestive Disease Institute, Gastroenterology and Hepatology Colorectal cancer, Virginia Mason Bellevue Clinic, Seattle, Washington, USA.

出版信息

Gastrointest Endosc. 2015 Feb;81(2):282-90. doi: 10.1016/j.gie.2014.10.009.

DOI:10.1016/j.gie.2014.10.009

PMID:25616752

Abstract

BACKGROUND

Characterization of indeterminate biliary strictures remains problematic. Tissue sampling is the criterion standard for confirming malignancy but has low sensitivity. Probe-based confocal laser endomicroscopy (pCLE) showed excellent sensitivity in a registry; however, it has not been validated in a prospective study.

OBJECTIVE

To prospectively validate pCLE in real time during ERCP for indeterminate biliary strictures.

DESIGN

Prospective, international, multicenter study.

SETTING

Six academic centers.

PATIENTS

A total of 136 patients with indeterminate biliary strictures.

INTERVENTIONS

Investigators provided a presumptive diagnosis based on the patient history, ERCP impression, and pCLE during the procedure before and after tissue sampling results were available. A presumptive diagnosis also was made separately by a blinded investigator during ERCP and after tissue sampling to estimate care without pCLE. Follow-up was at least 6 months.

MAIN OUTCOME MEASUREMENTS

Accuracy, sensitivity, and specificity during ERCP alone, ERCP with pCLE, and ERCP with pCLE and tissue sampling.

RESULTS

A total of 112 patients were evaluated (71 with malignant lesions). Tissue sampling alone was 56% sensitive, 100% specific, and 72% (95% confidence interval [CI], 63%-80%) accurate. pCLE with ERCP was 89% sensitive, 71% specific, and 82% (95% CI, 74%-89%) accurate. After tissue sampling returned, strictures could be characterized with 88% (95% CI, 81%-94%) accuracy.

LIMITATIONS

No randomization of care maps. pCLE not blinded.

CONCLUSION

pCLE provided a more accurate and sensitive diagnosis of cholangiocarcinoma compared with tissue sampling alone. Incorporation of pCLE into the diagnostic armamentarium of patients with indeterminate biliary strictures may allow for a more accurate assessment, potentially reducing delays in diagnosis and costly repeat testing. (

CLINICAL TRIAL REGISTRATION NUMBER

NCT01392274.).

摘要

背景

不确定的胆管狭窄的特征描述仍然存在问题。组织采样是确认恶性肿瘤的标准方法，但敏感性较低。基于探头的共聚焦激光内镜检查（pCLE）在一项登记研究中显示出极佳的敏感性；然而，它尚未在前瞻性研究中得到验证。

目的

在ERCP期间对不确定的胆管狭窄进行实时前瞻性验证pCLE。

设计

前瞻性、国际性、多中心研究。

地点

六个学术中心。

患者

总共136例不确定胆管狭窄患者。

干预措施

在组织采样结果出来之前和之后，研究人员在手术过程中根据患者病史、ERCP印象和pCLE提供初步诊断。一名不知情的研究人员在ERCP期间和组织采样后也分别做出初步诊断，以评估无pCLE时的诊疗情况。随访至少6个月。

主要观察指标

单独ERCP、ERCP联合pCLE以及ERCP联合pCLE和组织采样时的准确性、敏感性和特异性。

结果

共评估了112例患者（71例有恶性病变）。单独组织采样的敏感性为56%，特异性为100%，准确性为72%（95%置信区间[CI]，63%-80%）。ERCP联合pCLE的敏感性为89%，特异性为71%，准确性为82%（95%CI，74%-89%）。组织采样结果出来后，狭窄的特征描述准确性为88%（95%CI，81%-94%）。