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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03884179
Enrollment
58
Registered
2019-03-21
Start date
2007-02-01
Completion date
2020-03-01
Last updated
2019-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

None listed

Sponsors

Sahlgrenska University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL

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

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of EUS-FNA vs Radiology10 yearsTo 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

MeasureTime frameDescription
Accuracy of EUS-FNA vs morphology10 yearsTo 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 cytology10 yearsTo 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 CEA10 yearsTo 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026