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Trial record 15 of 131 for:    Pancreatic Cancer | ( Map: South Korea )

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

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ClinicalTrials.gov Identifier: NCT02190071
Recruitment Status : Completed
First Posted : July 15, 2014
Last Update Posted : May 27, 2016
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Brief 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.

Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 73 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of the Diagnostic Accuracy Between Base and Cover Slide Smear After Endoscopic Ultrasound Guided Fine Needle Aspiration for Pancreatic Cancer
Study Start Date : June 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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


Biospecimen Retention:   Samples Without DNA
One identical and skilled endoscopist's EUS-FNA sampling with multiple punctures


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02190071


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Chair: Jaihwan Kim, M.D. Seoul National University Bundang Hospital

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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02190071     History of Changes
Other Study ID Numbers: SNUBH-IMGPB-2014-03
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: May 27, 2016
Last Verified: July 2015
Keywords provided by Seoul National University Hospital:
EUS-FNA
cytopathology
slide smear
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases