Background and Aims

Recently, a 3-plane symmetric needle with Franseen geometry and a Fork-tip biopsy needle have been developed for histologic tissue procurement. We compared 22-gauge Franseen and 22-gauge Fork-tip needles in patients undergoing EUS-guided sampling of pancreatic masses.

Methods

Fifty patients underwent sampling using both 22-gauge Franseen and 22-gauge Fork-tip needles, with randomization of needle order. Two dedicated passes were performed using both needles for cell block. Subsequent passes were performed for rapid onsite evaluation (ROSE) using both needles alternately until diagnosis was established. The main outcome was to evaluate for histologic core tissue by comparing area of total tissue, tumor, desmoplastic fibrosis, and rate of retained tissue architecture between cohorts. Other outcomes were rates of diagnostic cell block and diagnostic adequacy at ROSE.

Results

Final diagnosis was pancreatic cancer in 44 patients, neuroendocrine tumor in 2, lymphoma in 1, and chronic pancreatitis in 3. There was no significant difference in area of total tissue (median 6.1 [interquartie range {IQR}, 3.5-10.5] vs 8.2 mm² [IQR, 4.0-13.0], P = .50), tumor (median .9 [IQR .3-2.8] vs 1.0 mm² [IQR .4-2.7], P = .33), desmoplastic fibrosis (median 4.3 [IQR, 2.0-6.7] vs 5.2 mm² [IQR, 1.7-6.1], P = .71), retained architecture (100% vs 83%, P = .25), diagnostic cell block (96.0% vs 92.0%, P = .32), and diagnostic adequacy at ROSE (94.0% vs 98.0%, P = .32) between Franseen and Fork-tip needles, respectively.

Conclusions

There was no significant difference between Franseen and Fork-tip needles in yielding histologic tissue. Given their ability to yield diagnostic cell block in greater than 90% of patients, the new-generation fine-needle biopsy needles may obviate the need for ROSE. (Clinical trial registration number: NCT02910960.)

中文翻译：

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随机对照试验比较Franseen和Fork-tip针在EUS指导下对实体胰腺肿块病变进行细针穿刺活检的样本

背景和目标

最近，已经开发了一种具有Franseen几何形状的3面对称针和一个叉尖活检针，用于组织学组织采购。我们在接受EUS指导的胰腺肿块采样的患者中比较了22号Franseen针和22号Fork尖针。

方法

50名患者同时使用22针Franseen针和22针Fork-tip针进行了采样，并随机分配了针头顺序。使用两个针头进行两次专门的传代以进行细胞阻断。随后通过交替使用两根针进行快速现场评估（ROSE），直到确定诊断为止。主要结果是通过比较整个组织之间的总组织面积，肿瘤，增生性纤维化以及保留的组织结构比率来评估组织学核心组织。其他结果是ROSE的诊断性细胞阻滞和诊断充分性的比率。

结果

最终诊断为胰腺癌44例，神经内分泌肿瘤2例，淋巴瘤1例，慢性胰腺炎3例。总组织面积无显着差异（中位值6.1 [interquartie range {IQR}，3.​​5-10.5] vs 8.2 mm ² [IQR，4.0-13.0]，P  = .50），肿瘤（中位.9 [IQR .3-2.8]与1.0 mm ² [IQR .4-2.7]，P  = .33），增生性纤维化（中位） 4.3 [IQR，2.0-6.7] vs 5.2 mm ² [IQR，1.7-6.1]，P  = .71），保留架构（100％vs 83％，P  = .25），诊断单元格（96.0％vs 92.0％ ，P  = 0.32）和ROSE的诊断适当性（94.0％vs 98.0％，P = 0.32）分别位于Franseen针和前叉针之间。

结论

Franseen针和叉尖针在产生组织学组织方面无显着差异。鉴于它们能够在90％以上的患者中产生诊断性细胞阻滞的能力，新一代的细针活检针可能会消除对ROSE的需求。（临床试验注册号：NCT02910960。）