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
1 other identifier
observational
58
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2007
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 24, 2018
CompletedFirst Posted
Study publicly available on registry
March 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedMarch 21, 2019
March 1, 2019
10.8 years
April 24, 2018
March 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Accuracy of EUS-FNA vs morphology
10 years
Accuracy of EUS FNA vs cytology
10 years
Accuracy of EUS FNA vs CEA
10 years
Eligibility Criteria
All patients with suspected PCLs according to radiology undergoing evaluation with EUS-FNA at a tertiarry endoscopy center from February 2007 until March 2017. The catchemnt area of this cente has a population of about two million.
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ass Prof
Study Record Dates
First Submitted
April 24, 2018
First Posted
March 21, 2019
Study Start
February 1, 2007
Primary Completion
December 1, 2017
Study Completion
March 1, 2020
Last Updated
March 21, 2019
Record last verified: 2019-03