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临床试验/NCT04834505
NCT04834505已完成不适用

Construction and Validation of a Diagnosis Model Based on Endoscopic Ultrasound Characteristics for Differentiating Between Focal Autoimmune Pancreatitis and Pancreatic Cancer

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 286 人开始时间: 2021年5月11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
286
试验地点
1
主要终点
To construct a diagnosis model for distinguishing FAIP from PC and further validate its efficacy

研究概览

简要总结

Autoimmune pancreatitis (AIP) is a special type of chronic pancreatitis mediated by autoimmunity. The classic manifestation of AIP is diffuse pancreatic enlargement, some of which are characterized by focal enlargement. Clinically, it is divided into diffuse AIP (DAIP) and focal AIP (FAIP) according to morphology. FAIP can be clinically manifested as obstructive jaundice, peripancreatic lymphadenopathy and vascular involvement, which may mimic pancreatic cancer (PC). CT/MRI is the important imaging tool for diagnosing pancreatic diseases. However, due to the overlap of the imaging features of FAIP and PC, it is challenging to differentiate the two by CT/MRI. Endoscopic ultrasound (EUS) can clearly display the pancreatic parenchyma and pancreatic duct system and has become a routine modality for the evaluation of pancreatic diseases. The aim of this study is to construct a diagnosis model for distinguishing between FAIP and PC by comparing the EUS characteristics of the two, and further validate its diagnostic efficacy.

详细描述

A derivation sample is established by retrospectively collecting the EUS images of about 100 FAIP patients and about 200 PC patients who were diagnosed for the first time in Peking Union Medical College Hospital in the past 6 years and underwent EUS at the same time. The parenchymal and ductal changes of pancreas were defined according to the Rosemont criteria. The parenchymal characteristics included hyperechoic foci/strands and lobularity, and the ductal changes included main pancreatic duct (MPD) dilation. Other EUS characteristics not included in the conventional criteria were described based on the literatures, including pancreatic diffuse hypoechogenicity, focal hypoechogenicity, pancreatic diffuse enlargement, focal enlargement, peripancreatic hypoechoic margin, common bile duct (CBD) dilation, bile duct wall thickening, lymphadenopathy and vessel involvement. The EUS characteristics of the two groups of patients are included in the multivariate stepwise logistic regression and receiver operating characteristics (ROC) analyses to construct a differential diagnosis model in derivation sample. Further, the differential diagnosis model will be prospectively validated by calculating the sensitivity and specificity in about 90 patients who are going to undergo EUS due to the difficulty in distinguishing between FAIP and PC. Diagnosis of AIP meets the revised Mayo clinic criteria (revised HISORt criteria) including features of histology, imaging, serology, other organs involvement and response to steroid therapy. Diagnosis of pancreatic duct adenocarcinoma is confirmed by surgical pathology or by cytology/histology after EUS-guided fine needle aspiration or biopsy.

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
— 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with difficulty in distinguishing between FAIP and PC

排除标准

  • Referred patients with a history of having being conclusively diagnosed as AIP or PC; Patients with DAIP; Patients with alcoholic pancreatitis, hypertriglyceridemia pancreatitis or pancreatitis due to gallstones; Patients with pancreatic cystic tumors, pancreatic neuroendocrine tumors or solid pseudopapillary tumors of pancreas; Patients who cannot undergo EUS due to unsuitable conditions.

结局指标

主要结局

To construct a diagnosis model for distinguishing FAIP from PC and further validate its efficacy

时间窗: 1 week after the diagnosis is conclusive

Score is assigned to each predictor based on the odd ratio (OR) value, individual risk is estimated based on the sum of weighted score for each predictor and optimal cut-off point is obtained based on receiver operating characteristic (ROC) analysis. Sensitivity and specificity were used to assess the diagnostic efficacy.

次要结局

  • Compare the efficacy of EUS based on the model with that of CT/MRI/PET-CT in differentiating between FAIP and PC(1 week after the diagnosis is conclusive)

研究者

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

Tao Guo

Associated professor in Department of Gastroenterolgy

Peking Union Medical College Hospital

研究点 (1)

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