Pancreatic CancerEUS-FNANCT02190071
Comparison Between Base and Cover Slide From Endoscopic Ultrasound Guided Fine Needle Aspiration for Pancreatic Cancer
An observational study of Pancreatic Cancer, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Cancer
- How many people
- 73 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients who visited to tertiary medical center(Seoul National University Bundang Hospital) because of suspicious pancreatic cancer in radiologic study
Who may be able to join
- patients who were suspected of pancreatic cancer in previous radiologic test such as computed tomography, magnetic resonance imaging or Positron Emission Tomography.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: 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.
Read the detailed description
- 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.
- Conditions
- Pancreatic Cancer
- Keywords
- EUS-FNA, cytopathology, slide smear
- Medical subject headings
- Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
positive malignancy rate of cover slides set and base slides set.
comparison between diagnostic accuracy between cover slide sets and base slide sets
Measured: cytopathological report within 2 weeks after EUS-FNA
Secondary outcomes (1)
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
Measured: record of pathologist within 2 weeks after EUS-FNA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaihwan Kim, M.D., Study chair, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190071
- Sponsor's protocol ID
- SNUBH-IMGPB-2014-03
- Acronym
- EUS-FNA
- Status last verified
- Jul 2015
- First submitted
- 6 Jul 2014
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Diagnostic Accuracy Between Base and Cover Slide Smear After Endoscopic Ultrasound Guided Fine Needle Aspiration for Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02190071
- Acronym / sponsor ID
- EUS-FNA / SNUBH-IMGPB-2014-03
- Conditions
- Pancreatic Cancer
- Keywords
- EUS-FNA, cytopathology, slide smear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients who visited to tertiary medical center(Seoul National University Bundang Hospital) because of suspicious pancreatic cancer in radiologic study
Key inclusion criteria (1 listed)
- patients who were suspected of pancreatic cancer in previous radiologic test such as computed tomography, magnetic resonance imaging or Positron Emission Tomography.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaihwan Kim, M.D. study chair
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positive malignancy rate of cover slides set and base slides set. (time frame: cytopathological report within 2 weeks after EUS-FNA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2016.