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临床试验/NCT03241797
NCT03241797已完成不适用

Evaluation of EUS-guided FNA for Diagnosing Autoimmune Pancreatitis: a Prospective, Single-center Study

Bin Cheng1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2013年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
27
试验地点
1
主要终点
evaluate the diagnostic yield of AIP patients by EUS-FNA .

研究概览

简要总结

The aim is to evaluate EUS-FNA efficacy for AIP diagnosis using a 22-gauge (G) needle.

详细描述

Patients who suggested having Autoimmune pancreatitis (AIP) and underwent endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) by using a standard 22-gauge aspiration needle were enrolled between January 2013 and May 2017. The enrollment criteria included age greater than 20 years at the time of enrollment; presence of imaging characteristics of AIP, as specified in the International Consensus Diagnostic Criteria(ICDC) (diffuse or segmental/focal enlargement with delayed enhancement and diffuse or segmental/focal or multiple irregular narrowing of the main pancreatic duct without marked upstream dilatation) was confirmed by computed tomography (CT), magnetic resonance imaging (MRI), or EUS. The exclusion criteria were steroid administration within 3 months before the initiation of treatment; refusal or inability to provide informed consent; episode of acute pancreatitis in previous 2 weeks; inability to safely perform EUS-FNA, such as cardiorespiratory dysfunction, mental diseases, coagulopathy and drug addiction.All procedures were performed under deep sedation by a single experienced endosonographer who had performed more than 500 cases. EUS-FNA was performed by using Olympus linear echoendoscopes , Diagnostic Ultrasound System and 22-G needle . Once the lesion was evaluated by EUS, the echoendoscopist would select the shortest pathway, while avoiding blood vessels, to reach the lesion. Under real-time visualization, slow-pull technique and suction technique were used to punctured each lesions. The specimens were expelled onto glass slides, and then prepared for histological and cytological examinations. Because neither pathologists nor cytologists were present on-site at our institution, the puncture was repeated until a whitish material could be observed macroscopically.Tissue samples were fixed in formalin and embedded in paraffin. A paraffin block was thin cut into serial sections and stained with hematoxylin-eosin(H&E). To detect infiltrated plasma cells, anti-IgG4 antibody would be done if necessary. The histologic analysis was made by an experienced pathologist who was blind to the kinds of studies referring to the histological criteria of the ICDC. The Lymphoplasmacytic sclerosing pancreatitis (LPSP ) findings are as follow: (1) Periductal lymphoplasmacytic infiltrate without granulocytic infiltration; (2) Obliterative phlebitis; (3)Storiform fibrosis; (4) Abundant (>10cells/HPF) immunoglobulin G4 (IgG 4)positive cells. The level-1 criteria of LPSP were positive for 3 or more of the 4 LPSP findings, and the level-2 criteria were positive for 2 of the 4 items. The idiopathic duct-centric chronic pancreatitis (IDCP) findings are as follow: (1) Granulocytic infiltration of duct wall (GEL) with or without granulocytic acinar inflammation; (2)Granulocytic and lymphoplasmacytic acinar infiltrate; (3)Absent or scant (0-10 cells/ High-power fields) IgG4-positive cells. The level-1 criteria of IDCP were positive for items (1) and (3), and the level-2 criteria were positive for items (2) and (3).Statistical analyses were performed with Statistical Analysis System (SAS) version 9.2. All tests were 2-tailed and a P value of less than 0.05 was considered to indicate a statistically significant difference. All category variables will be described in terms of the count and percentage using the χ 2 test, whereas the continuous variables will be described as mean ± standard deviation using τ tests or Wilcoxon rank-sum tests. Outpatients were observed for immediate complications in the recovery room for 2 hours and followed up on the day after the procedure to monitor for possible complications.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age >20 years old, <85 years old ; probable AIP.

排除标准

  • steroid administration within 3 months before the initiation of treatment; refusal or inability to provide informed consent; acute pancreatitis in previous 2 weeks; cardiorespiratory dysfunction; mental diseases; coagulopathy; drug addiction(asprin, clopidogrel).

研究组 & 干预措施

Patients who suggested having AIP

Experimental

Patients who suggested having AIP and underwent EUS-FNA biopsy by using a standard 22-gauge aspiration needle were enrolled between January 2013 and May 2017.

干预措施: EUS-FNA (Procedure)

结局指标

主要结局

evaluate the diagnostic yield of AIP patients by EUS-FNA .

时间窗: 52 months

The primary outcome measure is to evaluate the usefulness of EUS-FNA with 22-Gauge (G) needle in histological diagnosis of AIP patients.

次要结局

未报告次要终点

研究者

发起方
Bin Cheng
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Bin Cheng

professor

Huazhong University of Science and Technology

研究点 (1)

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