跳至主要内容
临床试验/NCT03884179
NCT03884179Unknown不适用

Diagnosis of Pancreatic Cystic Lesions With EUS-FNA and Cross-sectional Imaging - A Report of Accuracy

Sahlgrenska University Hospital, Sweden0 个研究点目标入组 58 人开始时间: 2007年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
58
主要终点
Accuracy of EUS-FNA vs Radiology

研究概览

简要总结

Pancreatic cystic lesions (PCLs) comprise of a heterogeneous group of entities that are benign, premalignant or malignant. With increased use of modern imaging techniques in recent years, incidentally discovered PCL have become much more common. However, imaging modalities for characterising PCL is a known clinical uncertainty since imaging is capable of detecting these lesions but may often not be able to distinguish malignant from benign lesions. Incorrect assessment of PCL can lead to fatal consequences because a malignant lesion may not be treated and a benign may be unnecessarily resected. The aim of this study was to assess the performance of endoscopic ultrasound with fine-needle aspiration (EUS-FNA) in the diagnosis of pancreatic cystic lesions compared to cross-sectional imaging modalities (CT/MRI). Our hypothesis is that EUS-FNA has a higher accuracy for diagnosing PCLs compared with cross-sectional imaging.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with suspected PCLs according to radiology undergoing evaluation with EUS-FNA at a tertiarry endoscopy center from February 2007 until March 2017, who underwent pancreas resection
  • Oral and written consent of patients examined

排除标准

  • 未提供

结局指标

主要结局

Accuracy of EUS-FNA vs Radiology

时间窗: 10 years

To compare the accuracy of EUS-FNA(morphology, cytology, CEA(ng/ml)) with CT/MRI in the diagnosis of pancreatic cystic lesions. Surgical pathology is used as gold standard Established CEA cut-offs of \>192 ng/ml were used for mucinous assessment and \>1000 ng/ml for established cancer assessment. A CEA value of 5 ng/ml or less was indicative of a serous cyst

次要结局

  • Accuracy of EUS FNA vs cytology(10 years)
  • Accuracy of EUS-FNA vs morphology(10 years)
  • Accuracy of EUS FNA vs CEA(10 years)

研究者

发起方
Sahlgrenska University Hospital, Sweden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Riadh Sadik

Ass Prof

Sahlgrenska University Hospital, Sweden

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