Dry Suction Versus Wet Suction of Endoscopic Ultrasound-Guided Fine-Needle Biopsy for Diagnosis of Solid Pancreatic Lesions: A Multicenter Randomized Controlled Noninferiority Trial.

IF 8.5 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY American Journal of Gastroenterology Pub Date : 2025-11-01 Epub Date: 2025-02-27 DOI:10.14309/ajg.0000000000003389
Shenglin Xu, Jianian Guo, Mengbin Qin, Yiteng Meng, Fang Xie, Weiguang Qiao, Haiyan Hu, Peng Peng, Jahan Rownoak, Socheat Heng, Finang Ung, Yaping Ye, Jing Wang, Weixin Li, Yingying Zou, Li Zou, Shaohui Huang, Side Liu, Junfen Wang, Jun Yao, Yue Li
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Abstract

Introduction: Conclusions regarding the suction techniques of endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) remain controversial. This study aimed to compare the diagnostic accuracy of the dry suction vs wet suction technique in solid pancreatic lesions (SPLs) and determine the optimal number of passes for EUS-FNB.

Methods: This investigation was conducted as a multicenter, randomized, controlled, noninferiority trial. Patients with SPLs were randomly allocated to receive either the dry or wet suction technique. The primary outcome was diagnostic accuracy. The secondary outcomes included sensitivity, specificity, optimal number of needle passes, specimen quality, procedure time, and adverse events.

Results: Of the 200 patients, 193 were included in the final analysis, with 96 in the dry suction group and 97 in the wet suction group. The diagnostic accuracies were 97.92% and 96.91% in the dry and wet groups, respectively, with a 1.01% difference between the study groups (2-sided 95% CI, -3.47% to 5.48%, P = 0.659). The overall adverse event rate was 2.6%. No significant differences were observed in sample adequacy (98.9% vs 98.9%, P = 1) or blood contamination ( P = 0.796). Regarding procedure time, there was no statistical difference (18.68 ± 8.03 minutes vs 19.36 ± 8.89 minutes, P = 0.626); however, more procedural steps were required in the wet suction technique. No significant difference was found between the cumulative diagnostic accuracy of each needle (first pass 93.78% vs second pass 95.34% vs third pass 97.41%, P = 0.225).

Discussion: The dry suction technique is noninferior to the wet suction technique for EUS-FNB in SPLs. In the absence of rapid on-site evaluation, only one pass was required to achieve more than 90% diagnostic accuracy ( ClinicalTrial.gov number NCT05549856).

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超声内镜引导下细针活检干吸与湿吸诊断胰腺实性病变:一项多中心随机对照非劣效性试验
背景和目的:有关 EUS-FNB 抽吸技术的结论仍存在争议。本研究旨在比较干抽吸与湿抽吸技术对胰腺实变(SPL)的诊断准确性,并确定 EUS-FNB 的最佳抽吸次数:这项研究是一项多中心、随机对照、非劣效试验。SPL患者被随机分配接受干法或湿法抽吸技术。主要结果是诊断准确性。次要结果包括敏感性、特异性、最佳进针次数、标本质量、手术时间和不良事件:在 200 名患者中,193 人被纳入最终分析,其中干抽吸组 96 人,湿抽吸组 97 人。干式抽吸组和湿式抽吸组的诊断准确率分别为 97.92% 和 96.91%,研究组之间的差异为 1.01%(双侧 95% CI,-3.47% 至 5.48%,P=0.659)。总体不良事件发生率为 2.6%。在样本充分性(98.9% 对 98.9%,P=1)或血液污染(P=0.796)方面未观察到明显差异。在手术时间方面,没有统计学差异(18.68±8.03 分钟 vs. 19.36±8.89 分钟,P=0.626);但是,湿式抽吸技术需要更多的手术步骤。每种针的累积诊断准确率之间没有发现明显差异(第 1 次 93.78% vs. 第 2 次 95.34% vs. 第 3 次 97.41%,P=0.225):讨论:在 SPL 的 EUS-FNB 中,干抽吸技术并不比湿抽吸技术差。在没有快速现场评估(ROSE)的情况下,只需通过一次即可达到 90% 以上的诊断准确率。(ClinicalTrial.gov 编号 NCT05549856)。
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来源期刊
American Journal of Gastroenterology
American Journal of Gastroenterology 医学-胃肠肝病学
CiteScore
11.40
自引率
5.10%
发文量
458
审稿时长
12 months
期刊介绍: Published on behalf of the American College of Gastroenterology (ACG), The American Journal of Gastroenterology (AJG) stands as the foremost clinical journal in the fields of gastroenterology and hepatology. AJG offers practical and professional support to clinicians addressing the most prevalent gastroenterological disorders in patients.
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