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

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

• Registration Number: NCT03884179
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-01
• Primary Completion: 2017-12-01
• Study First Submitted: 2018-04-24
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-19
• Last Update Submitted: 2019-03-19
• Study First Posted: 2019-03-21
• Last Update Posted: 2019-03-21
• Study Completion: 2020-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of EUS-FNA vs Radiology	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 Outcome Measures

Name	Time	Method
Accuracy of EUS FNA vs cytology	10 years	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
Accuracy of EUS-FNA vs morphology	10 years	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
Accuracy of EUS FNA vs CEA	10 years	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