采用可调节光源改良宏观现场评估技术可显著提升EUS-FNA胰腺标本充足率与诊断准确率:一项随机交叉对照试验OA
Improved visualization with an adjustable-light modified macroscopic on-site evaluation technique enhances specimen adequacy and diagnostic accuracy in EUS-FNA for pancreatic lesions:A randomized crossover trial
目的 明确改良宏观现场评估(macroscopic on-site evaluation,MOSE)能否提升22G/25G FNA标本中核心组织条(macroscopic visible core,MVC)的可视化效果,进而提高标本充足率及病理诊断准确性.方法 本研究为单中心、前瞻性、随机交叉对照试验,连续纳入2023年2月至2024年8月成都市第三人民医院消化内科拟行超声内镜引导下细针穿刺抽吸术(endoscopic ultrasound-guided fine needle aspiration,EUS-FNA)的胰腺实性占位患者90例.患者通过计算机生成的随机序列按1∶1分配至A组(第一针采用传统MOSE,第二针采用改良MOSE)或B组(第一针采用改良MOSE,第二针采用传统MOSE).改良MOSE的核心参数为:白光强度调节范围为35～1 700 LUX,光源发光面与标本载玻片底部距离固定为37.2 mm,以MVC≥4 mm定义为标本充足.主要结局指标为2组的标本充足率,次要结局指标为细胞病理及组织病理诊断准确率.研究通过盲法评估(病理医师及数据分析人员不知情分组)、标准化操作流程控制偏倚.结果 改良MOSE组的标本充足率显著高于传统MOSE组[70.0%(95%CI:59.9%～78.5%)vs 43.3%(95%CI:33.6%～54.6%),χ²=13.714,P<0.001].次要结局方面,改良MOSE组的细胞病理诊断准确率[94.4%(95%CI:87.7%～97.6%)vs 85.6%(95%CI:76.8%～91.4%),χ2=4.9,P=0.021)及组织条病理诊断准确率[95.6%(95%CI:89.1%～98.3%)vs 83.3%(95%CI:76.8%～91.4%),χ2=7.69,P=0.003]均显著优于传统MOSE组.在针型的亚组分析中显示,在占比87.8%(79/90)的22G针型中,改良MOSE组的标本充足率[65.8%(95%CI:55.1%～76.5%)vs 41.8%(95%CI:30.7%～52.9%),P=0.003]、细胞诊断准确率[93.7%(95%CI:88.1%～99.2%)vs 84.8%(95%CI:76.7%～92.9%),P=0.039]、组织诊断准确率[94.9%(95%CI:90.0%～99.9%)vs 82.3%(95%CI:73.7%～90.9%),P=0.013]比传统MOSE组更有优势.结论 改良MOSE能提升22G/25G FNA标本中 MVC 的可视化效果,进而提高标本充足率及病理诊断准确性.
Objective Determine whether a modified macroscopic on-site evaluation(MOSE)technique,by enhancing visualization of the macroscopic visible core(MVC)in 22G/25G fine needle aspiration(FNA)specimens,improves specimen adequacy and pathological diagnostic accuracy.Methods This single-center,prospective,randomized crossover trial enrolled 90 consecutive patients with solid pancreatic lesions scheduled for EUS-FNA from the Department of Gastroenterology at the Third People's Hospital of Chengdu between February 2023 and August 2024.Patients were randomly assigned(1∶1)via a computer-generated sequence to Group A(first pass using traditional MOSE,second pass using modified MOSE)or Group B(first pass using modified MOSE,second pass using traditional MOSE).The core modification was the use of an adjustable white light source from 35 to 1 700 LUX at a fixed distance(37.2 mm)from the slide.Specimen adequacy was defined as MVC≥4 mm.The primary outcome was the specimen adequacy rate between groups.Secondary outcomes included the diagnostic accuracy of cytopathology and histopathology.Bias was controlled through blinded assessment(pathologists and data analysts were unaware of group allocation)and standardized operating procedures.Results The specimen adequacy rate was significantly higher in the modified MOSE group(70.0%,95%CI:59.9 to 78.5%)than in the traditional MOSE group(43.3%,95%CI:33.6 to 54.6%;χ²=13.714,P<0.001).The modified MOSE group also demonstrated superior diagnostic accuracy for both cytopathology[94.4%(95%CI:87.7%～97.6%)vs 85.6%(95%CI:76.8%～91.4%),χ2=4.9,P=0.021)and histopathology of tissue strips[95.6%(95%CI:89.1%～98.3%)vs 83.3%(95%CI:76.8%～91.4%),χ2=7.69,P=0.003].Subgroup analysis based on needle gauge demonstrated that for the 22G needle,which constituted 87.8%(79/90)of cases,the modified MOSE demonstrated statistically significant advantages over the traditional MOSE in the following outcomes:specimen adequacy rate[65.8%(95%CI:55.1%to 76.5%)vs 41.8%(95%CI:30.7%to 52.9%),P=0.003],cytological diagnostic accuracy[93.7%(95%CI:88.1%to 99.2%)vs 84.8%(95%CI:76.7%to 92.9%),P=0.039],and histological diagnostic accuracy[94.9%(95%CI:90.0%to 99.9%)vs 82.3%(95%CI:73.7%to 90.9%),P=0.013].Conclusion Modified MOSE can enhance the visualization of the MVC in specimens obtained by 22G/25G FNA,thereby improving the specimen adequacy rate and pathological diagnostic accuracy.
周希;单晶;邓梦怡;罗丹;赵明;孙晓滨;姜琳
成都市第三人民医院消化内科,四川成都成都市第三人民医院消化内科,四川成都||西南交通大学医学院,四川成都西南交通大学医学院,四川成都西南交通大学医学院,四川成都成都市第三人民医院消化内科,四川成都成都市第三人民医院消化内科,四川成都成都市第三人民医院消化内科,四川成都
医药卫生
超声内镜引导下细针穿刺抽吸术胰腺肿瘤现场评估
endoscopic ultrasound-guided fine needle aspirationpancreatic neoplasmsmacroscopic on-site evaluation
《陆军军医大学学报》 2026 (3)
337-344,8
成都市第三人民医院科研项目(2023PI21)成都市第三人民医院临床研究计划(CSY-YN-01-2023-049) Supported by the Research Project of the Third People's Hospital of Chengdu(2023PI21)and the Clinical Research Program of the Third People's Hospital of Chengdu(CSY-YN-01-2023-049).
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