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临床试验/JPRN-UMIN000032598
JPRN-UMIN000032598已完成未知

A prospective study for comparing newly designed 21-gauge and standard 22-gauge aspiration needles for the diagnosis of solid pancreatic masses - Prospective study comparing 21-gaude and 22-gauge needles for EUS-FNA of pancreatic masses

Japanese Red Cross Wakayama Medical Center0 个研究点目标入组 100 人开始时间: 2018年5月25日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
100

研究概览

简要总结

A total of 93 patients (40.9 % female; mean age 70.1 years) underwent EUS-FNA with the novel 21-gauge needle (n = 47) or the standard 22-gauge needle (n = 46). Baseline characteristics did not differ between the groups. The technical success rate was 100% in both groups, and the overall diagnostic accuracy for malignancy was similar between the groups (100 % in the 21-gauge group vs. 95.7% in the 22-gauge group, P = 0.242). Nevertheless, the 21-gauge needle resulted in significantly higher scores for cellularity (P = 0.010), and lower scores for blood contamination (P < 0.001). The median number of needle passes using the 21-gauge needle was less as compared to the 22-gauge needle (2 and 3, respectively, P = 0.003). The needle angle during puncture was more restricted in the 21-gauge needle (P < 0.001). Procedure-related complication rate was not different between the groups (P = 0.148).

研究设计

研究类型
Interventional

入排标准

年龄范围
20years-old 至 ot applicable(—)
性别
All

入选标准

  • 未提供

排除标准

  • 1. Patients with ECOG Performance status 4 2. Patients with bleeding tendency (prothrombin time international normalized ratio >1.5, platelets <50000) 3. Patients with pancreatic mass which cannot be visualized on EUS 4. Patients younger than 20 years old 5. Patients who do not agree to participate in this study

研究者

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