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

Pancreatic Cyst Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03884179
• Other study ID #: SahlgrenskaUHGEA2017
• Status: Active, not recruiting
• Start date: February 1, 2007
• Est. completion date: March 1, 2020

Study information

• Verified date: March 2019
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: March 1, 2020
• Est. primary completion date: December 1, 2017
• Gender: All
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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