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超声内镜引导下细针穿刺抽吸活检标本中 K-ras 基因突变分析对胰腺肿块的临床影响。

Clinical impact of K-ras mutation analysis in EUS-guided FNA specimens from pancreatic masses.

机构信息

Department of Gastroenterology, Aichi Cancer Center Hospital, Nagoya, Japan.

出版信息

Gastrointest Endosc. 2012 Apr;75(4):769-74. doi: 10.1016/j.gie.2011.11.012. Epub 2012 Jan 28.

DOI:10.1016/j.gie.2011.11.012
PMID:22284089
Abstract

BACKGROUND

EUS-guided FNA (EUS-FNA) is considered optimal for differentially diagnosing pancreatic masses. However, the sensitivity of EUS-FNA ranges from 65% to 95%, respectively, which requires improvement.

OBJECTIVE

To evaluate clinical impact of K-ras mutation analysis in EUS-FNA specimens from pancreatic masses.

DESIGN

Prospective registration, single-center study.

SETTING

Tertiary referral center.

PATIENTS

This study involved 394 consecutive patients with pancreatic masses (307 pancreatic ductal adenocarcinomas [PDACs], 47 pancreatic inflammatory lesions, and 40 other types of tumors) who underwent EUS-FNA and analysis of K-ras mutations.

INTERVENTION

EUS-FNA, Cycleave polymerase chain reaction.

MAIN OUTCOME MEASUREMENTS

Improvement of the diagnostic accuracy by K-ras mutation analysis; absence of K-ras mutations in non-PDAC masses.

RESULTS

K-ras mutations were detected in 266 of 307 PDAC aspirates (87%) and in 3 of 87 non-PDAC masses (3%). K-ras mutations were detected in 18 of 39 patients (46%) who remained cytohistopathologically undiagnosed. The sensitivity, specificity, positive and negative predictive values, and accuracy of cytohistopathological and K-ras mutation analyses alone were 87%, 100%, 100%, 54%, and 89%, respectively, and, when combined, were 93%, 100%, 100%, 68%, and 94%, respectively. Adding K-ras mutation analysis to standard cytohistopathological assessment increased the sensitivity and accuracy of EUS-FNA by 6% (P < .001) and 5% (P < .001), respectively.

LIMITATIONS

Single-center study.

CONCLUSIONS

K-ras mutation analysis may be helpful in patients with suspected PDAC yet inconclusive EUS-FNA findings. K-ras mutations were extremely rare in pancreatic inflammation and other pancreatic tumors.

摘要

背景

EUS 引导下的细针抽吸(EUS-FNA)被认为是鉴别胰腺肿块的最佳方法。然而,EUS-FNA 的敏感性分别为 65%至 95%,需要提高。

目的

评估 K-ras 基因突变分析对 EUS-FNA 胰腺肿块标本的临床影响。

设计

前瞻性注册,单中心研究。

设置

三级转诊中心。

患者

本研究纳入了 394 例连续的胰腺肿块患者(307 例胰腺导管腺癌 [PDAC]、47 例胰腺炎症性病变和 40 例其他类型肿瘤),他们接受了 EUS-FNA 和 K-ras 基因突变分析。

干预

EUS-FNA、Cycleave 聚合酶链反应。

主要观察指标

K-ras 基因突变分析提高诊断准确性;非 PDAC 肿块中不存在 K-ras 突变。

结果

在 307 例 PDAC 抽吸物中检测到 266 例(87%)和 87 例非 PDAC 肿块中 3 例(3%)的 K-ras 突变。在 39 例仍未通过细胞组织病理学诊断的患者中,有 18 例(46%)检测到 K-ras 突变。单独进行细胞组织病理学和 K-ras 基因突变分析的敏感性、特异性、阳性和阴性预测值及准确性分别为 87%、100%、100%、54%和 89%,联合应用时分别为 93%、100%、100%、68%和 94%。将 K-ras 基因突变分析添加到标准细胞组织病理学评估中,分别提高了 EUS-FNA 的敏感性和准确性 6%(P<0.001)和 5%(P<0.001)。

局限性

单中心研究。

结论

K-ras 基因突变分析可能有助于疑似 PDAC 但 EUS-FNA 结果不确定的患者。K-ras 突变在胰腺炎症和其他胰腺肿瘤中极为罕见。

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