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内镜超声(EUS)弹性成像引导下细针穿刺抽吸细胞学检查(FNAC)与传统EUS-FNAC用于实性胰腺病变:一项初步随机试验。

Endoscopic ultrasound (EUS) elastography-guided fine-needle aspiration cytology (FNAC) versus conventional EUS FNAC for solid pancreatic lesions: A pilot randomized trial.

作者信息

Nayak Hemanta Kumar, Rai Abhijeet, Gupta Shubham, Prakash Jain Harsh, Patra Susama, Panigrahi Chinmayee, Patel Ranjan Kumar, Pattnaik Brahmadatta, Kar Madhabananda, Panigrahi Manas Kumar, Samal Subash Chandra

机构信息

Department of Gastroenterology, All India Institute of Medical Sciences, Bhubaneswar, 751 019, India.

Department of Pathology, All India Institute of Medical Sciences, Bhubaneswar, 751 019, India.

出版信息

Indian J Gastroenterol. 2024 Sep 4. doi: 10.1007/s12664-024-01673-4.

DOI:10.1007/s12664-024-01673-4
PMID:39230660
Abstract

BACKGROUND

Endoscopic ultrasound guided fine-needle aspiration (EUS FNA) is the first-line modality to diagnose suspected solid pancreatic malignant lesions. Elastography-guided FNA has been shown to improve the diagnostic yield of EUS FNA but prospective studies are limited. The aim of the study was to compare diagnostic accuracy, sensitivity and specificity of conventional and elastography-guided EUS FNA in patients with suspected malignant pancreatic solid masses.

METHODS

Patients with suspected malignant solid pancreatic lesions presenting to our institute from July 2021 to January 2023 were recruited and randomized to conventional and elastography-guided EUS FNA using a 22-G EUS FNA needle. Diagnostic accuracy, sensitivity, specificity and positive and negative predictive values were calculated.

RESULTS

Total 48 patients were initially screened for inclusion in the study, of which six were excluded and 42 patients underwent randomization. Finally, 20 patients in each group underwent the assigned intervention and were analyzed further. Baseline patient characteristics were similar in conventional FNA and elastography-guided FNA group with median age 52 (range 29-74) years and 51.8 (range 31-72) years, respectively, males being 70% and 75%, respectively. Median size of the lesion was 34 mm (range 14-48 mm) and 37 (range 18 to 50 mm), respectively, for both conventional and elastography arm. The average size of the lesion was 35.7 mm. Overall, the diagnosis of adenocarcinoma was made in 65% of cases. In the remaining cases, diagnoses were inflammatory mass, Castleman's disease, solid pseudopapillary epithelial neoplasm (SPEN), diffuse large B-cell lymphoma (DLBCL), pancreatic gastrointestinal stromal tumor (GIST) and metastasis. Conventional EUS FNA had diagnostic accuracy, sensitivity, specificity and positive and negative predictive values of 90%, 87.5%, 100%, 100% and 62.92%, respectively, and elastography-guided EUS FNA had diagnostic accuracy, sensitivity, specificity and positive and negative predictive values of 85%, 100%, 100% and 54.59%, respectively. No severe adverse events were noted.

CONCLUSION

There is no significant difference between conventional and elastography-guided EUS FNA in terms of diagnostic accuracy, sensitivity, specificity and positive and negative predictive values. Both techniques appear safe and effective for characterizing solid pancreatic masses and elastography did not score numerically over the conventional arm.

摘要

背景

内镜超声引导下细针穿刺抽吸术(EUS-FNA)是诊断疑似胰腺实性恶性病变的一线方法。弹性成像引导下的细针穿刺抽吸术已被证明可提高EUS-FNA的诊断率,但前瞻性研究有限。本研究的目的是比较传统EUS-FNA与弹性成像引导下EUS-FNA对疑似胰腺实性肿块患者的诊断准确性、敏感性和特异性。

方法

招募2021年7月至2023年1月到我院就诊的疑似胰腺实性恶性病变患者,并使用22G EUS-FNA针将其随机分为传统EUS-FNA组和弹性成像引导下EUS-FNA组。计算诊断准确性、敏感性、特异性以及阳性和阴性预测值。

结果

最初共筛选了48例患者纳入研究,其中6例被排除,42例患者接受随机分组。最后,每组20例患者接受指定干预并进行进一步分析。传统FNA组和弹性成像引导下FNA组患者的基线特征相似,中位年龄分别为52岁(范围29-74岁)和51.8岁(范围31-72岁),男性分别占70%和75%。传统组和弹性成像组病变的中位大小分别为34mm(范围14-48mm)和37mm(范围18-50mm)。病变的平均大小为35.7mm。总体而言,65%的病例诊断为腺癌。其余病例的诊断为炎性肿块、Castleman病、实性假乳头状上皮性肿瘤(SPEN)、弥漫性大B细胞淋巴瘤(DLBCL)、胰腺胃肠道间质瘤(GIST)和转移瘤。传统EUS-FNA的诊断准确性、敏感性、特异性以及阳性和阴性预测值分别为90%、87.5%、100%、100%和62.92%,弹性成像引导下EUS-FNA的诊断准确性、敏感性、特异性以及阳性和阴性预测值分别为85%、100%、100%和54.59%。未观察到严重不良事件。

结论

传统EUS-FNA与弹性成像引导下EUS-FNA在诊断准确性、敏感性、特异性以及阳性和阴性预测值方面无显著差异。两种技术对于胰腺实性肿块的特征性诊断似乎都是安全有效的,并且弹性成像在数值上并未超过传统方法。

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