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

March 19, 2019 updated by: Riadh Sadik, Sahlgrenska University Hospital, Sweden

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Actual)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of EUS-FNA vs Radiology Time Frame: 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	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of EUS-FNA vs morphology Time Frame: 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	10 years
Accuracy of EUS FNA vs cytology Time Frame: 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	10 years
Accuracy of EUS FNA vs CEA Time Frame: 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	10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2007

Primary Completion (Actual)

December 1, 2017

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

April 24, 2018

First Submitted That Met QC Criteria

March 19, 2019

First Posted (Actual)

March 21, 2019

Study Record Updates

Last Update Posted (Actual)