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2014-06
2016-03
2016-03
73
NCT02190071
Seoul National University Hospital
Seoul National University Hospital
OBSERVATIONAL
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.
1. background 1. Pancreatic cancer is the challenging malignancy in diagnosis and treatment. 2. Recently, EUS-FNA has played a important role in diagnosing pancreatic cancer. 3. Samples from EUS-FNA are sent to following three types of preparations. * cytologic smear (by pull apart method) * cell block * histologic biopsy 4. In cytologic smear method, endoscopists tend to send as many as slides, while pathologists want minimal slides if they warrant diagnostic accuracy. 5. Therefore we are going to find a point of contact between high diagnostic yield and minimal overloading of pathologist. 2. Method 1. We are going to enrolled the patients who were suspected of pancreatic cancer in previous radiologic test. 2. One identical and skilled endoscopist performs EUS-FNA with multiple punctures. 3. We get total 8 pairs of slides (= 8 covers + 8 bases). 4. All the cover slides are collected to the bottle-A, all the base slide to the bottle-B. 5. 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.) 6. She record the positive or negative in each bottle. (If there is only one slide is positive in malignant cell, the bottle is positive.) 7. 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) = (-/-) 8. Then we are going to take a two-sided non-inferiority test of proportion using McNemar's test.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2014-07-06 | N/A | 2016-05-25 |
2014-07-11 | N/A | 2016-05-27 |
2014-07-15 | N/A | 2015-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| positive malignancy rate of cover slides set and base slides set. | comparison between diagnostic accuracy between cover slide sets and base slide sets | cytopathological report within 2 weeks after EUS-FNA |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| positive malignancy rate of (1) cytologic smear, (2) cell block and (3) histologic biopsy | comparison of three types of test in rate of positive malignancy | record of pathologist within 2 weeks after EUS-FNA |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
