Interventional and Experimental Endoscopy, Department of Internal Medicine I, Ulm University, Ulm, Germany.
Institute of Pathology, Klinikum Bayreuth, Bayreuth, Germany.
United European Gastroenterol J. 2020 Apr;8(3):314-320. doi: 10.1177/2050640619887580. Epub 2019 Nov 7.
The use of 19-gauge (G) stainless steel needles for endoscopic ultrasound-guided fine-needle biopsy of a pancreatic mass often results in technical difficulties due to an inability to advance the relatively rigid needle out of the endoscope. More flexible nitinol-based needles might decrease such technical difficulties and thus increase diagnostic accuracy.
In this prospective multicenter randomized single-blinded study we compared the diagnostic value of those two needle types in patients with a solid pancreatic lesion.
Patients with a solid pancreatic mass were diagnosed with endoscopic ultrasound-guided fine-needle biopsy using one puncture with each needle in a randomized fashion. The primary endpoint was the diagnostic accuracy of each needle. Secondary endpoints included time for puncture, amount of tumour tissue obtained, and technical failure. Histological specimens were centrally reviewed by a pathologist blinded to the final needle type and final diagnosis (ClinicalTrials.gov Identifier: NCT02909530).
Out of 46 prospectively recruited patients, central pathological examination was available for 41. Diagnostic accuracy for the two needles combined was 87.8%. Diagnostic accuracy was 66% and 68% using the stainless steel- and nitinol-based needle respectively. Time spent for puncturing was 137 ± 61 s (mean ± standard deviation) for the stainless steel and 111 ± 53 s for the nitinol-based needle ( = 0.037). Technical failure occurred in three (6.5%) cases using the stainless steel- and in none using the nitinol-based needle.
Usage of a nitinol-based 19-G needle failed to present a significant superior accuracy compared with a stainless steel needle in endoscopic ultrasound-guided fine-needle biopsy of solid pancreatic lesions.
由于无法将相对刚性的针从内窥镜中推出，19 号（G）不锈钢针用于内镜超声引导下胰腺肿块细针活检时经常会遇到技术困难。基于镍钛诺的更灵活的针可能会减少这种技术困难，从而提高诊断准确性。
在这项前瞻性多中心随机单盲研究中，我们比较了这两种针在胰腺实性病变患者中的诊断价值。
采用随机穿刺的方式，用每种针进行一次穿刺，对胰腺实性肿块的患者进行内镜超声引导下细针活检。主要终点是两种针的诊断准确性。次要终点包括穿刺时间、获得的肿瘤组织量和技术失败。组织学标本由一名对最终针类型和最终诊断均不知情的病理学家进行中心审查（ClinicalTrials.gov 标识符：NCT02909530）。
在 46 例前瞻性招募的患者中，有 41 例接受了中心病理检查。两种针联合的诊断准确性为 87.8%。使用不锈钢针和镍钛诺针的诊断准确性分别为 66%和 68%。不锈钢针穿刺时间为 137±61 秒（平均值±标准差），镍钛诺针为 111±53 秒（P=0.037）。使用不锈钢针时技术失败发生在 3 例（6.5%）中，而使用镍钛诺针时未发生技术失败。
在胰腺实性病变的内镜超声引导下细针活检中，与不锈钢针相比，镍钛诺针的使用并未显著提高准确性。
