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

NCT ID: NCT03884179

Last Updated: 2019-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-02-01

Study Completion Date

2020-03-01

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.

Detailed Description

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Riadh Sadik

Ass Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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SahlgrenskaUHGEA2017

Identifier Type: -

Identifier Source: org_study_id

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