Diagnosis of Pancreatic Cystic Lesions With EUS-FNA and Cross-sectional Imaging - A Report of Accuracy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreatic Cyst
- Sponsor
- Sahlgrenska University Hospital, Sweden
- Enrollment
- 58
- Primary Endpoint
- Accuracy of EUS-FNA vs Radiology
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Riadh Sadik
Ass Prof
Sahlgrenska University Hospital, Sweden
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Accuracy of EUS-FNA vs Radiology
Time Frame: 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
Secondary Outcomes
- Accuracy of EUS FNA vs cytology(10 years)
- Accuracy of EUS-FNA vs morphology(10 years)
- Accuracy of EUS FNA vs CEA(10 years)