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一项比较 25G 和 20G 活检针对内镜超声引导下胰腺实性病变取样的前瞻性、随机、多中心临床试验。

A prospective, randomized, multicenter clinical trial comparing 25-gauge and 20-gauge biopsy needles for endoscopic ultrasound-guided sampling of solid pancreatic lesions.

机构信息

Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Republic of Korea.

Department of Internal Medicine, Wonkwang University College of Medicine, Iksan, Republic of Korea.

出版信息

Surg Endosc. 2020 Mar;34(3):1310-1317. doi: 10.1007/s00464-019-06903-x. Epub 2019 Jun 17.

Abstract

BACKGROUND

Various core biopsy needles have previously been developed for endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB). However, the properties of needle gauge in the diagnostic outcomes of solid pancreatic lesions remain unknown. This trial compared the procurement rates of histologic cores from solid pancreatic lesions with EUS-FNB using 20- and 25-gauge (G) FNB needles.

METHODS

In a prospective randomized multicenter clinical trial, patients with solid pancreatic lesions underwent EUS-FNB with either a 20-gauge or a 25-gauge FNB needle. The rates of histologic core procurement, overall diagnostic accuracy, and adverse events were compared between the two groups (20-gauge or 25-gauge FNB needle).

RESULTS

In total, 88 patients (48 men, 40 women, mean age 65.7 years) were enrolled. No significant differences were found in the demographic characteristics between the two groups (20-gauge or 25-gauge FNB needle). The procurement rate of histologic cores in the 20-guage FNB needle group (41/45, 91.1%) was significantly higher than that in the 25-guage FNB needle group (32/43, 74.4%, P = 0.037). However, no significant differences were found in the overall diagnostic accuracy between 20-guage FNB needle (40/45, 88.9%) and 25-guage FNB needle (34/43, 79.1%, P = 0.208). No procedure-related adverse events were observed in either group.

CONCLUSIONS

Although both FNB needles provided high overall diagnostic accuracy, the reliability of the 20-guage FNB needle is better than the 25-guage FNB needle when retrieving samples for histological analysis.

摘要

背景

以前已经开发了各种用于内镜超声引导下细针活检(EUS-FNB)的核心活检针。然而,针规在实性胰腺病变诊断结果中的特性尚不清楚。本试验比较了 20 号和 25 号(G)FNB 针进行 EUS-FNB 对实性胰腺病变获取组织芯的采集率。

方法

在一项前瞻性随机多中心临床试验中,对患有实性胰腺病变的患者进行 EUS-FNB,使用 20 号或 25 号 FNB 针。比较两组(20 号或 25 号 FNB 针)的组织芯采集率、总体诊断准确性和不良事件。

结果

共纳入 88 例患者(48 名男性,40 名女性,平均年龄 65.7 岁)。两组患者的人口统计学特征无显著差异(20 号或 25 号 FNB 针)。20 号 FNB 针组(41/45,91.1%)的组织芯采集率显著高于 25 号 FNB 针组(32/43,74.4%,P=0.037)。然而,20 号 FNB 针(40/45,88.9%)和 25 号 FNB 针(34/43,79.1%)之间的总体诊断准确性无显著差异(P=0.208)。两组均未观察到与操作相关的不良事件。

结论

尽管两种 FNB 针都提供了较高的总体诊断准确性,但在进行组织学分析时,20 号 FNB 针的可靠性优于 25 号 FNB 针。

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