经口胆管镜直视下基于探头的共聚焦激光显微内镜诊断胆管狭窄：一项前瞻性研究的结果（附视频）

Diagnosis of Biliary Strictures Using Probe-Based Confocal Laser Endomicroscopy under the Direct View of Peroral Cholangioscopy: Results of a Prospective Study (with Video).

作者信息

Tanisaka Yuki, Ryozawa Shomei, Nonaka Kouichi, Yasuda Masami, Fujita Akashi, Ogawa Tomoya, Mizuide Masafumi, Tashima Tomoaki, Araki Ryuichiro

机构信息

Department of Gastroenterology, Saitama Medical University International Medical Center, Japan.

Department of Digestive Endoscopy, Tokyo Women's Medical University, Japan.

出版信息

Gastroenterol Res Pract. 2020 Dec 31;2020:6342439. doi: 10.1155/2020/6342439. eCollection 2020.

BACKGROUND

The accurate diagnosis of biliary strictures remains problematic. The aim of the present study was to prospectively evaluate the clinical utility of probe-based confocal laser endomicroscopy (pCLE) under the direct view of peroral cholangioscopy (POCS) for the diagnosis of biliary strictures.

METHODS

Consecutive patients with biliary strictures were included. We investigated sensitivity, specificity, and accuracy to diagnose malignancy for (1) ERCP alone, (2) POCS, (3) pCLE under the direct view of POCS, and (4) tissue sampling under the direct view of POCS.

RESULTS

A total of 30 patients (17 with malignant lesions) were prospectively enrolled. (1) ERCP alone showed 88.2% sensitivity, 46.2% specificity, and 70% (95% confidence interval (CI), 52.1%-83.3%) accuracy. (2) POCS showed 100% sensitivity, 76.9% specificity, and 90% (95% CI, 74.4%-96.5%) accuracy. (3) pCLE under the direct view of POCS showed 94.1% sensitivity, 92.3% specificity, and 93.3% (95% CI, 78.7%-98.8%) accuracy. (4) Tissue sampling under the direct view of POCS showed 82.4% sensitivity, 100% specificity, and 90% (95% CI, 74.4%-96.5%) accuracy.

CONCLUSIONS

pCLE under the direct view of POCS provided highly accurate and sensitive characterization of biliary strictures and showed the potential for more diagnostic reliability and reduction of delays in diagnosis. This trial was registered at UMIN (registration number: UMIN000033801).

背景

胆管狭窄的准确诊断仍然存在问题。本研究的目的是前瞻性评估经口胆管镜检查（POCS）直视下基于探头的共聚焦激光内镜检查（pCLE）对胆管狭窄诊断的临床效用。

方法

纳入连续的胆管狭窄患者。我们研究了（1）单纯内镜逆行胰胆管造影（ERCP）、（2）POCS、（3）POCS直视下的pCLE以及（4）POCS直视下组织采样诊断恶性肿瘤的敏感性、特异性和准确性。

结果

前瞻性纳入了30例患者（17例有恶性病变）。（1）单纯ERCP的敏感性为88.2%，特异性为46.2%，准确性为70%（95%置信区间（CI），52.1%-83.3%）。（2）POCS的敏感性为100%，特异性为76.9%，准确性为90%（95%CI，74.4%-96.5%）。（3）POCS直视下的pCLE敏感性为94.1%，特异性为92.3%，准确性为93.3%（95%CI，78.7%-98.8%）。（4）POCS直视下组织采样的敏感性为82.4%，特异性为100%，准确性为90%（95%CI，74.4%-96.5%）。