Randomized controlled trial comparing the Franseen needle with the Fork-tip needle for EUS-guided fine-needle biopsy.,Gastrointestinal Endoscopy

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Randomized controlled trial comparing the Franseen needle with the Fork-tip needle for EUS-guided fine-needle biopsy.
Gastrointestinal Endoscopy ( IF 6.7 ) Pub Date : 2020-06-09 , DOI: 10.1016/j.gie.2020.05.057
Munish Ashat ₁ , Jagpal S Klair ₁ , Sydney L Rooney ₂ , Sagar J Vishal ₂ , Chris Jensen ₂ , Nadav Sahar ₁ , Arvind R Murali ₁ , Rami El-Abiad ₁ , Henning Gerke ₁

Affiliation

Background and Aims

EUS-guided FNA primarily provides cytologic samples. EUS-guided fine-needle biopsy (FNB) with needles that provide histologic specimens may enhance diagnostic yield and facilitate accessory tissue staining. Several different needle designs are currently available and design superiority is unknown. We designed a randomized controlled trial to compare 2 commonly used EUS-FNB needles in their ability to provide histologic tissue samples (primary endpoint) and to reach an accurate diagnosis (secondary endpoint).

Methods

A total of 150 lesions from 134 patients (November 2018 to June 2019) were randomized 1:1 between biopsy with a Franseen needle and a Fork-tip needle. The groups were compared regarding the quality of the tissue samples and diagnostic accuracy.

Results

Of 150 lesions, 75 were pancreatic and 75 were other solid lesions in and around the GI tract. There was no statistically significant difference between the Franseen needle and the Fork-tip needle in the yield of adequate histologic samples, 71 of 75 (94.7%) versus 72 of 75 (96%), (P = 1.00), an absolute difference of −1.3% (95% confidence interval [CI], −8.1% to 5.4%). The 2 groups were similar in the diagnostic accuracy of histologic analysis, 64 of 75 (85.3%) versus 68 of 75 (90.7%) (P = .45), absolute difference −5.4% (95% CI, −15.7% to 5%); and in the diagnostic accuracy of combined cytologic and histologic analysis, 65 of 75 (86.7%) versus 69 of 75 (92%) (P = .43), absolute difference −5.3% (95% CI, −15.2% to 4.5%).

Conclusions

There was no significant difference in the performance of the Franseen needle versus the Fork-tip needle. Both needles achieved a high yield of histologic tissue samples and high diagnostic accuracy. (Clinical trial registration number: NCT03672032.)

中文翻译：

随机对照试验比较了Franseen针和Fork-tip针进行EUS引导的细针穿刺活检。

背景和目标

EUS指导的FNA主要提供细胞学样品。EUS引导的提供组织学标本的细针穿刺活检（FNB）可提高诊断率并促进辅助组织染色。当前有几种不同的针头设计，而设计优势尚不清楚。我们设计了一项随机对照试验，比较了2种常用EUS-FNB针提供组织学样本（主要终点）和达到准确诊断（次要终点）的能力。

方法

从134例患者（2018年11月至2019年6月）中，总共有150个病变在Franseen针和Fork-tip针的活检之间按1：1随机分配。比较各组的组织样本质量和诊断准确性。

结果

在150个病变中，胃肠道内和周围的75个是胰腺病变，另外75个是其他实体病变。Franseen针与前叉针头之间的组织学样本产量无统计学差异，75的71（94.7％）与75的72（96％）相比，（P = 1.00） -1.3％（95％置信区间[CI]，-8.1％至5.4％）。两组在组织学分析的诊断准确性上相似，分别为75个中的64个（85.3％）和75个中的68个（90.7％）（P = .45），绝对差异为-5.4％（95％CI，-15.7％至5）％）; 在细胞学和组织学分析相结合的诊断准确性中，75分之65（86.7％）与75分之69（92％）（P = .43），绝对差为-5.3％（95％CI，-15.2％至4.5％））。