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

Pancreatic Cancer Clinical Trial

— EUS-FNA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02190071
• Other study ID #: SNUBH-IMGPB-2014-03
• Status: Completed
• Phase: N/A
• First received: July 6, 2014
• Last updated: May 25, 2016
• Start date: June 2014
• Est. completion date: March 2016

Study information

• Verified date: July 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No