Role of Endoscopic Ultrasound-guided Fine-needle Biopsy in the Diagnosis of Autoimmune Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- The primary aim is to evaluate the capability of EUS-FNB to enhance diagnostic levels of AIP, that means to obtain definitive diagnosis of type 1 and type 2 AIP.
研究概览
简要总结
According to the reported histological procurement yield of the end-cutting needles, the investigators supposed that the use of EUS-FNB in probable AIP patients, generally aimed only to rule-out malignancy, could provide histological tissue samples useful in enhancing the diagnostic level reached without histology, or defining the type of AIP.
详细描述
The primary aim is to evaluate the capability of EUS-FNB to enhance diagnostic levels of AIP, that means to obtain definitive diagnosis of type 1 and type 2 AIP. Secondary aims are to evaluate: Safety of EUS-FNB in this setting of patients; the possibility to obtain a definitive diagnosis in focal/segmental form of AIP (that are the most clinically relevant because of the mimicking of cancer); diagnostic yield of EUS-FNB in this patient population; the rate of pancreatic neoplasms mimicking AIP.
Consecutive patients ≥ 18 years old, with suspected focal or diffuse AIP, according to ICDC (probable type 1 AIP; probable type 2 AIP; NOS-AIP) with written consent to participate in the study will be enrolled.
Exclusion criteria include: previous diagnosis of AIP; definitive type 1 AIP; steroid administration within 3 months before the EUS-FNB; coagulation disorders; pregnancy and lactation; unability to give informed consent .
The histopathology of the preparations will be evaluated, according to the ICDC, including the LPSP findings and the IDCP findings and recording the absence or presence of specific criteria: Periductal lymphoplasmacytic infiltrate without GELs, Storiform fibrosis, Obliterative phlebitis >10 IgG4-positive cells per HPF; GEL of duct wall; Granulocytic and lympho- plasmacytic acinar infiltrate.
According to the current clinical practice, when the diagnosis of AIP is confirmed (and malignancy is ruled-out) patient will be treated with the standard therapy for AIP. Patients will be followed for 12 months, in order to exclude misdiagnosed malignancy, and to evaluate the clinical course of the disease (response to steroid therapy, relapses, changes in imaging findings or surgical pathology in resected patients).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients ≥ 18 years old;
- •Suspected focal or diffuse AIP, according to ICDC:
- •Probable type 1 AIP Probable type 2 AIP NOS-AIP
- •provision of written consent to participate in the study.
排除标准
- •Previous diagnosis of AIP
- •Definitive type 1 AIP
- •Steroid administration within 3 months before the EUS-FNB
- •Coagulation disorders
- •Pregnant and lactating women
- •Unable to give informed consent
结局指标
主要结局
The primary aim is to evaluate the capability of EUS-FNB to enhance diagnostic levels of AIP, that means to obtain definitive diagnosis of type 1 and type 2 AIP.
时间窗: 2 years
For the primary aim, the endpoint is the percentage of cases where EUS-FNB histology improve the diagnostic level: * from a probable AIP 1 to definitive AIP 1 (i.e., percentage of type 1 Level 1 H); * from a probable AIP 2 to definitive AIP 2 (i.e., percentage of type 2 Level 1 H); * from an AIP-NOS to AIP 1 or 2 (i.e., percentage of type 1 and 2, Level 1 H or Level 2 H).
次要结局
- Diagnostic yield of EUS-FNB in this patient population.(2 years)
- The possibility to obtain a definitive diagnosis in focal/segmental form of AIP (that are the most clinically relevant because of the mimicking of cancer).(2 years)
- The rate of pancreatic neoplasms mimicking AIP(2 years)
- Safety of EUS-FNB in AIP patients: percentage of adverse events observed(2 years)
研究者
Stefano Francesco Crinò, MD
MD
Azienda Ospedaliera Universitaria Integrata Verona