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临床试验/NCT05565066
NCT05565066已完成不适用

A Real-world Comparison of FNB and FNA in IHC-required Lesions: A Prospective, Multicenter Study.

Huazhong University of Science and Technology1 个研究点 分布在 1 个国家目标入组 439 人开始时间: 2014年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
439
试验地点
1
主要终点
Diagnostic yields of EUS-FNA with EUS-FNB for solid masses

研究概览

简要总结

Endoscopic ultrasound (EUS)-guided fine needles with side fenestrations are used to collect aspirates for cytology analysis and biopsy samples for histologic analysis. The investigators conducted a large, multicenter study to compare the accuracy of diagnosis via specimens collected with fine-needle biopsy (FNB) versus fine-needle aspiration (FNA) for patients with lesions requiring immunohistochemistry (IHC) pathological diagnosis.

详细描述

Current guidelines recommend FNA and FNB needles equally for pancreatic and other deep-seated lesions. However, some studies indicate that the sample adequacy for histologic evaluation is higher when using FNB compared with FNA needles. The diagnosis of neuroendocrine tumor (NET), autoimmune pancreatitis (AIP), and other gastrointestinal stromal tumors require high-quality tissue sampling for IHC diagnosis. Whether FNB is superior to FNA in these IHC-required lesions remains unclear.

The investigators performed this at 2 tertiary care centers in China. The study prospectively collected patients undergoing EUS for a solid mass (>1 cm) in the pancreas, abdomen, mediastinum, or pelvic cavity from December 2014 diagnosed with AIP, NET, mesenchymal tumors, and Lymphoma. Patients accepted FNB or FNA according to doctors' and patients' willingness in a real-world setting. All procedures were performed by experienced endosonographers; cytologists and pathologists were blinded to the sample collection method. Patients were followed for at least 48 weeks, and final diagnoses were obtained after surgery, imaging analysis, or resolution of the lesion. The primary aim was to compare diagnostic yields of EUS-FNA with EUS-FNB for all solid masses, then separately as AIP, NET, mesenchymal tumors, and lymphoma. The secondary endpoint was the quality of the histologic specimen.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age >18 years;
  • presence of a solid mass lesion was confirmed by at least 1 imaging modality and it was located within pancreas, abdomen, mediastinum, or pelvic cavity;
  • mass size >1 cm;
  • final diagnoses were obtained after surgery, imaging analysis, or resolution of the lesion, including AIP, NET, mesenchymal tumors, and lymphoma.

排除标准

  • coagulopathy (international normalized ratio, 1.5);
  • thrombocytopenia (platelet count <50,000/mm3);
  • acute pancreatitis within the previous 2 weeks;
  • inability to safely perform EUS-TA (eg, cardiorespiratory dysfunction, mental diseases, or drug addiction);
  • refusal or inability to provide an informed consent.

结局指标

主要结局

Diagnostic yields of EUS-FNA with EUS-FNB for solid masses

时间窗: From admission until the date of pathological diagnosis obtained or follow-up up to 24 months

dignostic yields of GIST

次要结局

  • Quality of histologic specimen(From admission until specimen evaluted by two independent pathologists, assessed up to 4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bin Cheng

Dr.

Huazhong University of Science and Technology

研究点 (1)

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