Comparison Between Base and Cover Slide From Endoscopic Ultrasound Guided Fine Needle Aspiration for Pancreatic Cancer (EUS-FNA)

Comparison of the Diagnostic Accuracy Between Base and Cover Slide Smear After 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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patients who visited to tertiary medical center(Seoul National University Bundang Hospital) because of suspicious pancreatic cancer in radiologic study

Description

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

Study Plan

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
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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Chair: Jaihwan Kim, M.D., Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: July 6, 2014
• First Submitted That Met QC Criteria: July 11, 2014
• First Posted (Estimate): July 15, 2014

Study Record Updates

• Last Update Posted (Estimate): May 27, 2016
• Last Update Submitted That Met QC Criteria: May 25, 2016
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: EUS-FNA; cytopathology; slide smear
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: SNUBH-IMGPB-2014-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No