Diagnosis of PCL With EUS-FNA and Cross-sectional Imaging - A Report of Accuracy

Study Overview
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Brief Summary
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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.

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

Conditions
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Pancreatic Cyst, Pancreatic Neuroendocrine Carcinoma, Pancreatic Pseudocyst, Pancreatic Serous Cystadenoma, Pancreatic Mucinous Cystadenoma, Pancreatic Cystadenocarcinoma, Pancreatic Intraductal Papillary-Mucinous Neoplasm, Solid Pseudopapillary Tumor of the Pancreas

Participation Criteria
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Eligibility Criteria
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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: None
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of EUS-FNA vs Radiology | 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 | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of EUS-FNA vs morphology | To compare the accuracy of EUS-FNA(morphology, cytology, CEA(ng/ml)) with EUS morphology alone 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 | 10 years | 
| Accuracy of EUS FNA vs cytology | To compare the accuracy of EUS-FNA(morphology, cytology, CEA (ng/ml)) with EUS cytology alone 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 | 10 years | 
| Accuracy of EUS FNA vs CEA | To compare the accuracy of EUS-FNA(morphology, cytology, CEA (ng/ml)) with EUS CEA(ng/ml) alone 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 | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic ultrasound, Radiology, Accuracy, Pancreatic Cyst, Pancreatic Cystadenocarcinoma, Pancreatic Mucinous Cystadenoma, Pancreatic Intraductal Papillary-Mucinous Neoplasm, Pancreatic Serous Cystadenoma, Pancreatic Pseudocyst, Pancreatic Neuroendocrine Tumor, Solid Pseudopapillary Tumor of the Pancreas