Background & Aims

Given the lack of procedure standardization, findings vary from analyses of pancreatic tissues collected by endoscopic ultrasound–guided fine-needle biopsy. It is not clear which needle and technique yield the best specimen for analysis. We compared the specimen quality and accuracy of diagnoses made from samples collected by fine-needle biopsy needles using different collection techniques.

Methods

Patients found to have pancreatic masses during imaging (n = 129) were assigned randomly to groups from whom pancreatic tissue samples were collected by reverse-bevel, Menghini-tip, franseen, or fork-tip needles. A second randomization determined the technical sequence of biopsies in each patient (suction, no suction, and stylet retraction). Two independent pathologists, blinded to the type of needle and sampling technique, analyzed all the samples. Final diagnoses of malignancy were made based on surgical resection, death from cancer progression, or findings from radiology or clinical follow-up evaluations (reference standard). The primary objective was to compare the cellularity of the samples collected, defined as the proportion of core tissue in the biopsy sample. Secondary objectives were to compare the accuracy of diagnoses made from biopsy samples and identify factors associated with high cellularity.

Results

One-hundred and nine patients had a final diagnosis of malignancy (84.5%) and 20 patients had benign disease (15.5%). Samples collected by fork-tip or franseen needles had significantly higher cellularity than samples collected by reverse-bevels or Menghini-tip needles (P < .001). Neoplasias were identified with greater than 90% accuracy using samples collected by fork-tip or franseen needles (P < .001 compared with other needles). On multivariable regression analysis, use of franseen needles (odds ratio [OR], 4.42; 95% CI, 2.58–7.58; P < .001) or fork-tip needles (OR, 3.86; 95% CI, 2.24–6.64; P < .001), stylet retraction (OR, 2.13; 95% CI, 1.21–3.72; P = .008), no suction (OR, 2.74; 95% CI, 1.57–4.80; P < .001), and pancreatic mass larger than 3 cm (OR, 1.92; 95% CI, 1.21–3.05; P = .005) were associated with high cellularity of the sample.

Conclusions

In patients with suspected pancreatic cancer, samples with the highest degree of cellularity in a single biopsy, resulting in a diagnostic accuracy of 90% of higher, were collected by fine-needle biopsy using the franseen or fork-tip needle. Clinicaltrials.gov no: NCT04085055.

中文翻译：

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在一项随机试验中比较内窥镜超声引导细针活检的针头和方法，以优化胰腺肿块患者的标本质量和诊断准确性

背景与目标

由于缺乏程序标准化，结果与通过内窥镜超声引导的细针活检收集的胰腺组织的分析不同。目前尚不清楚哪种针头和技术能产生最好的分析样本。我们比较了使用不同采集技术的细针活检针采集的样本的样本质量和诊断准确性。

方法

在成像过程中发现有胰腺肿块的患者 (n = 129) 被随机分配到通过反向斜角、Menghini-tip、fraseen 或叉尖针收集胰腺组织样本的组中。第二次随机化确定了每位患者活检的技术顺序（抽吸、不抽吸和管心针回缩）。两名独立的病理学家对针的类型和取样技术一无所知，分析了所有样本。恶性肿瘤的最终诊断是基于手术切除、癌症进展导致的死亡或放射学或临床随访评估的结果（参考标准）。主要目的是比较收集的样本的细胞含量，定义为活检样本中核心组织的比例。

结果

199 名患者最终诊断为恶性肿瘤 (84.5%)，20 名患者为良性疾病 (15.5%)。叉尖或弗兰森针采集的样本比反斜面或孟吉尼尖针采集的样本具有显着更高的细胞结构 ( P < .001)。使用叉尖针或法兰针收集的样本识别肿瘤的准确率超过 90%（与其他针相比，P < .001）。在多变量回归分析中，使用法兰针（优势比 [OR]，4.42；95% CI，2.58–7.58；P < .001）或叉尖针（OR，3.86；95% CI，2.24–6.64；P < .001），管心针回缩（OR，2.13；95% CI，1.21-3.72；P  = .008 ），无吸引（OR，2.74；95% CI，1.57-4.80；P < .001），并且胰腺肿块大于 3 cm（OR，1.92；95% CI，1.21–3.05；P  = .005）与样本的高细胞含量有关。

结论

对于疑似胰腺癌的患者，使用弗兰森或叉尖针通过细针活检收集单次活检中细胞含量最高的样本，诊断准确率高达 90%。Clinicaltrials.gov 编号：NCT04085055。