Comparison Between Base and Cover Slide From Endoscopic Ultrasound Guided Fine Needle Aspiration for Pancreatic Cancer

The purpose of this study is to determine whether there is a difference of diagnostic accuracy between cover slides and base slides from EUS-FNA cytopathologic sample in patients who were previously suspected of pancreatic cancer in radiologic test.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

background

Pancreatic cancer is the challenging malignancy in diagnosis and treatment.
Recently, EUS-FNA has played a important role in diagnosing pancreatic cancer.
Samples from EUS-FNA are sent to following three types of preparations.

cytologic smear (by pull apart method)
cell block
histologic biopsy
In cytologic smear method, endoscopists tend to send as many as slides, while pathologists want minimal slides if they warrant diagnostic accuracy.
Therefore we are going to find a point of contact between high diagnostic yield and minimal overloading of pathologist.
Method

We are going to enrolled the patients who were suspected of pancreatic cancer in previous radiologic test.
One identical and skilled endoscopist performs EUS-FNA with multiple punctures.
We get total 8 pairs of slides (= 8 covers + 8 bases).
All the cover slides are collected to the bottle-A, all the base slide to the bottle-B.
One identical and skilled pathologist inspects these slide in blind method. (She cannot show the label of bottle so that she does not know what bottle is A or B.)
She record the positive or negative in each bottle. (If there is only one slide is positive in malignant cell, the bottle is positive.)
In these manner, we collect the all subjects' cytopathologic results as a pair of outcome. All the possible combinations are following four examples:

(cover/base) = (positive/positive) = (+/+)
(cover/base) = (positive/negative) = (+/-)
(cover/base) = (negative/positive) = (-/+)
(cover/base) = (negative/negative) = (-/-)
Then we are going to take a two-sided non-inferiority test of proportion using McNemar's test.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients who were suspected of pancreatic cancer in previous radiologic test such as computed tomography, magnetic resonance imaging or Positron Emission Tomography.

Exclusion criteria

failed smear due to inexperienced assistant
loss of slide
patients who were diagnosed with other lesion far from pancreatic cancer in prospective confirmative tests.
patients who refuse to participate in this study
report of other pathologist who are not a previously-assigned pathologist

Treatment and study plan

Primary outcomes

positive malignancy rate of cover slides set and base slides set.

Time frame: cytopathological report within 2 weeks after EUS-FNA

comparison between diagnostic accuracy between cover slide sets and base slide sets

Secondary outcomes

positive malignancy rate of (1) cytologic smear, (2) cell block and (3) histologic biopsy

Time frame: record of pathologist within 2 weeks after EUS-FNA

comparison of three types of test in rate of positive malignancy

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Comparison of the Diagnostic Accuracy Between Base and Cover Slide Smear After Endoscopic Ultrasound Guided Fine Needle Aspiration for Pancreatic Cancer

Acronym: EUS-FNA

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Jul 15, 2014
Registry last updated: May 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed