Pancreatic NeoplasmEUS-FNANCT01354795
Prospective Study Comparing Methods of Obtainment of Specimen After EUS-FNA in Patients With Peri-pancreatic Mass
A study testing 1.EUS-FNA with or without suction and 2.Pushing the stylet or injecting air in people with Pancreatic Neoplasm and Neoplasm of Intra-abdominal Lymph Nodes, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
EUS-guided FNA has been proved to be a safe and useful method for tissue sampling of gastrointestinal track lesions and other organ lesions including mediastinal and intra-abdominal lymph nodes, pancreas and hepatobiliary tree. The usefulness of EUS-FNA depends on several factors. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pancreatic Neoplasm, Neoplasm of Intra-abdominal Lymph Nodes
- What is being tested?
- 1.EUS-FNA with or without suction and 2.Pushing the stylet or injecting air
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2010to Mar 2011
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years
- Presence of peri pancreatic mass, mediastinal or intra-abdominal lymphadenopathy confirmed by investigational modality - CT scan, magnetic resonance imaging, EUS.
- Capable of providing informed consent
Who cannot join
- Severe coagulopathy (INR > 1.5) or thrombocytopenia (platelet count < 50,000)
- History of acute pancreatitis in the preceding 4 weeks
- Pregnancy
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
EUS-guided FNA has been proved to be a safe and useful method for tissue sampling of gastrointestinal track lesions and other organ lesions including mediastinal and intra-abdominal lymph nodes, pancreas and hepatobiliary tree. The usefulness of EUS-FNA depends on several factors. For example, experience of the endosonographers, adequate sampling, sample preparing, accurate interpretation by the cytopathologist and on-site cytopathology interpretation. However, in many hospitals, no cytopathologist can be present during EUS-FNA. Therefore, determining appropriate methods to obtain and prepare EUS-guided FNA are important to make correct a diagnosis without on-site cytopathologist.
Suction with a self-retracting 10-mL syringe will likely bring in more cellularity but also more blood. Some endosonographers use no suction, others use constant suction. Usually specimen is expelled from a needle with pushing the stylet into the needle. But use of the stylet during EUS-FNA is difficult and time consuming process. Injecting air was not recommended, because of spraying out uncontrollably, increasing risk of air artifact and specimen clotting. However, there is no further study which one is the appropriate, suction or no suction and pushing the stylet or injecting air until now.
Read more
The hypothesis and aim of the prospective randomized controlled trials are as follows:
First hypothesis: There was no difference in the adequacy, cellularity, bloodiness, contamination, air artifact in specimen obtained by each methods, suction or no suction and pushing the stylet or injecting air.
Aim #1 : To compare the adequacy, cellularity, bloodiness, contamination, air artifact in specimen obtained by each methods, suction or no suction and pushing the stylet or injecting air.
Second hypothesis: There was no difference in sensitivity, specificity, diagnostic accuracy, positive predictive value, negative predictive value and statistical agreement in specimen obtained by each methods, suction or no suction and pushing the stylet or injecting air.
Aim #2 : To compare the sensitivity, specificity, diagnostic accuracy, positive predictive value, negative predictive value and statistical agreement in specimen obtained by each methods, suction or no suction and pushing the stylet or injecting air.
Read the detailed description
On-site cytopathology interpretation during EUS-FNA has a significant clinical impact by increasing the diagnostic yield of the FNA. However, many hospitals do not have provision for on- site diagnosis of EUS FNA specimen. Therefore, optimal specimen obtainment and preparation of EUS FNA are is important to accurate diagnosis. EUS FNA is performed with or without self-retracting 10-mL syringe according to endosonographer's preference. In general, if there is too little cellularity on immediate cytologic evaluation, then use more suction, and, conversely, if the samples are too bloody, then use less suction. However, it is hard to determine the quality of specimen without on-site cytopathology interpretation. The actual way material is expressed from the needle may influence yield. Injecting air to express the material is problematic, because the material may spray out uncontrollably, risk of air artifact and specimen clotting may increase . A more controlled method is to pushing the stylet and slowly advance it to the needle tip. But use of the stylet during EUS-FNA is not only difficult and time consuming process but also increasing the risk of accidental needle stick injury. However, there is no firm evidence which one is the appropriate, suction or no suction and pushing the stylet or injecting air. If there was no significant difference between each methods, appropriate methods of obtaining and preparing aspirates undergoing EUS-FNA is no suction and injecting air and EUS FNA may perform more easier and shorter.
In this prospective randomized controlled trial, patients with peripancreatic mass for EUS-FNA will be included. One patient will be underwent at least four puncture during EUS-FNA. The sequence of EUS-FNA with first four methods will be selected by using a randomization scheme obtained from a sealed envelope : (1) negative pressure suction with 10 mL syringe and pushing the stylet; (2) negative pressure suction with 10 mL syringe and injecting air; (3) without negative pressure suction and pushing the stylet; (4) without negative pressure suction and injecting air. EUS FNA will be performed by two experienced endosonographers. All specimens will be read by same experienced pathologist blinded to methods.
The investigators will compare between the four groups in terms of adequacy, cellularity, bloodiness, contamination, air artifact. The sensitivity, specificity, diagnostic accuracy, positive predictive value, negative predictive value and statistical agreement for the different methods will be calculated.
- Being tested
- 1.EUS-FNA with or without suction, 2.Pushing the stylet or injecting air
- Keywords
- EUS FNA, stylet, suction
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.EUS-FNA with or without suctionProcedure or surgery
Also called EUS-FNA with or without suction
During EUS-FNA of the peri-pancreatic mass was performed, with or without self-retracting 10-mL syringe applied.
2.Pushing the stylet or injecting airProcedure or surgery
Also called Pushing the stylet or injecting air
EUS-FNA specimen is expelled from a needle with pushing the stylet or injecting air into the needle
| Study group | Role | What they receive |
|---|---|---|
| 1.EUS-FNA with or without suction | Experimental | During EUS FNA is performed, with or without self-retracting 10-mL syringe Receives: Procedure: 1.EUS-FNA with or without suction |
| 2.Pushing the stylet or injecting air | Experimental | EUS-FNA specimen is expelled from a needle with pushing the stylet into the needle or injecting air Receives: Procedure: 2.Pushing the stylet or injecting air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the degree of cytologic quality in specimen obtained by EUS-FNA with or without suction, pushing the stylet or injecting air.
The primary endpoint of this study is to determine that there is no difference in cytologic quality of FNA specimens with or without suction, pushing the stylet or injecting air: to compare the adequacy, cellularity, bloodiness, contamination, air artifact in specimen obtained by each methods.
Measured: within 6 months
Secondary outcomes (1)
Compare the diagnostic yield in specimen obtained by EUS-FNA with or without suction, pushing the stylet or injecting air.
The secondary endpoint of this study is to determine that there is no difference in diagnostic yield of FNA specimens with or without suction, pushing the stylet or injecting air: to compare the sensitivity, specificity, diagnostic accuracy, positive predictive value, negative predictive value and statistical agreement in specimen obtained by each methods.
Measured: within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2011 (estimated)
- Study startSep 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic NeoplasmStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Kwang Hyuck Lee, M.D., Study director, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354795
- Sponsor's protocol ID
- 2010-07-219
- Acronym
- EUS-FNA
- Status last verified
- May 2011
- First submitted
- 24 Apr 2011
- Last updated
- 17 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee JK, Choi JH, Lee KH, Kim KM, Shin JU, Lee JK, Lee KT, Jang KT. A prospective, comparative trial to optimize sampling techniques in EUS-guided FNA of solid pancreatic masses. Gastrointest Endosc. 2013 May;77(5):745-51. doi: 10.1016/j.gie.2012.12.009. Epub 2013 Feb 21.
PubMed 23433878
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Comparing Methods of Obtainment of Specimen After EUS-FNA in Patients With Peri-pancreatic Mass
- ClinicalTrials.gov ID
- NCT01354795
- Acronym / sponsor ID
- EUS-FNA / 2010-07-219
- Keywords
- EUS FNA, stylet, suction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 17 May 2011 (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.
EUS-guided FNA has been proved to be a safe and useful method for tissue sampling of gastrointestinal track lesions and other organ lesions including mediastinal and intra-abdominal lymph nodes, pancreas and hepatobiliary tree. The usefulness of EUS-FNA depends on several factors. For example, experience of the endosonographers, adequate sampling, sample preparing, accurate interpretation by the cytopathologist and on-site cytopathology interpretation. However, in many hospitals, no cytopathologist can be present during EUS-FNA. Therefore, determining appropriate methods to obtain and prepare EUS-guided FNA are important to make correct a diagnosis without on-site cytopathologist.
Suction with a self-retracting 10-mL syringe will likely bring in more cellularity but also more blood. Some endosonographers use no suction, others use constant suction. Usually specimen is expelled from a needle with pushing the stylet into the needle. But use of the stylet during EUS-FNA is difficult and time consuming process. Injecting air was not recommended, because of spraying out uncontrollably, increasing risk of air artifact and specimen clotting. However, there is no further study which one is the appropriate, suction or no suction and pushing the stylet or injecting air until now.
The hypothesis and aim of the prospective randomized controlled trials are as follows:
First hypothesis: There was no difference in the adequacy, cellularity, bloodiness, contamination, air artifact in specimen obtained by each methods, suction or no suction and pushing the stylet or injecting air.
Aim #1 : To compare the adequacy, cellularity, bloodiness, contamination, air artifact in specimen obtained by each methods, suction or no suction and pushing the stylet or injecting air.
Second hypothesis: There was no difference in sensitivity, specificity, diagnostic accuracy, positive predictive value, negative predictive value and statistical agreement in specimen obtained by each methods, suction or no suction and pushing the stylet or injecting air.
Aim #2 : To compare the sensitivity, specificity, diagnostic accuracy, positive predictive value, negative predictive value and statistical agreement in specimen obtained by each methods, suction or no suction and pushing the stylet or injecting air.
Detailed description
On-site cytopathology interpretation during EUS-FNA has a significant clinical impact by increasing the diagnostic yield of the FNA. However, many hospitals do not have provision for on- site diagnosis of EUS FNA specimen. Therefore, optimal specimen obtainment and preparation of EUS FNA are is important to accurate diagnosis. EUS FNA is performed with or without self-retracting 10-mL syringe according to endosonographer's preference. In general, if there is too little cellularity on immediate cytologic evaluation, then use more suction, and, conversely, if the samples are too bloody, then use less suction. However, it is hard to determine the quality of specimen without on-site cytopathology interpretation. The actual way material is expressed from the needle may influence yield. Injecting air to express the material is problematic, because the material may spray out uncontrollably, risk of air artifact and specimen clotting may increase . A more controlled method is to pushing the stylet and slowly advance it to the needle tip. But use of the stylet during EUS-FNA is not only difficult and time consuming process but also increasing the risk of accidental needle stick injury. However, there is no firm evidence which one is the appropriate, suction or no suction and pushing the stylet or injecting air. If there was no significant difference between each methods, appropriate methods of obtaining and preparing aspirates undergoing EUS-FNA is no suction and injecting air and EUS FNA may perform more easier and shorter.
In this prospective randomized controlled trial, patients with peripancreatic mass for EUS-FNA will be included. One patient will be underwent at least four puncture during EUS-FNA. The sequence of EUS-FNA with first four methods will be selected by using a randomization scheme obtained from a sealed envelope : (1) negative pressure suction with 10 mL syringe and pushing the stylet; (2) negative pressure suction with 10 mL syringe and injecting air; (3) without negative pressure suction and pushing the stylet; (4) without negative pressure suction and injecting air. EUS FNA will be performed by two experienced endosonographers. All specimens will be read by same experienced pathologist blinded to methods.
The investigators will compare between the four groups in terms of adequacy, cellularity, bloodiness, contamination, air artifact. The sensitivity, specificity, diagnostic accuracy, positive predictive value, negative predictive value and statistical agreement for the different methods will be calculated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1.EUS-FNA with or without suction | Experimental | Procedure: 1.EUS-FNA with or without suctionDuring EUS FNA is performed, with or without self-retracting 10-mL syringe |
| 2.Pushing the stylet or injecting air | Experimental | Procedure: 2.Pushing the stylet or injecting airEUS-FNA specimen is expelled from a needle with pushing the stylet into the needle or injecting air |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than 18 years
- Presence of peri pancreatic mass, mediastinal or intra-abdominal lymphadenopathy confirmed by investigational modality - CT scan, magnetic resonance imaging, EUS.
- Capable of providing informed consent
Key exclusion criteria (4 listed)
- Severe coagulopathy (INR > 1.5) or thrombocytopenia (platelet count < 50,000)
- History of acute pancreatitis in the preceding 4 weeks
- Pregnancy
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1.EUS-FNA with or without suctionAlso: EUS-FNA with or without suctionDuring EUS-FNA of the peri-pancreatic mass was performed, with or without self-retracting 10-mL syringe applied. | Procedure or surgery | 1.EUS-FNA with or without suction |
| 2.Pushing the stylet or injecting airAlso: Pushing the stylet or injecting airEUS-FNA specimen is expelled from a needle with pushing the stylet or injecting air into the needle | Procedure or surgery | 2.Pushing the stylet or injecting air |
Primary outcome
Compare the degree of cytologic quality in specimen obtained by EUS-FNA with or without suction, pushing the stylet or injecting air.
Time frame: within 6 months
The primary endpoint of this study is to determine that there is no difference in cytologic quality of FNA specimens with or without suction, pushing the stylet or injecting air: to compare the adequacy, cellularity, bloodiness, contamination, air artifact in specimen obtained by each methods.
1 secondary outcome
Compare the diagnostic yield in specimen obtained by EUS-FNA with or without suction, pushing the stylet or injecting air.
Time frame: within 6 months
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 17 May 2011.
- Derived from this study: PubMed 23433878Lee JK, Choi JH, Lee KH, Kim KM, Shin JU, Lee JK, Lee KT, Jang KT. A prospective, comparative trial to optimize sampling techniques in EUS-guided FNA of solid pancreatic masses. Gastrointest Endosc. 2013 May;77(5):745-51. doi: 10.1016/j.gie.2012.12.009. Epub 2013 Feb 21.
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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.
Kwang Hyuck Lee, M.D. study director
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1.EUS-FNA with or without suction and 2.Pushing the stylet or injecting air in people with Pancreatic Neoplasm and Neoplasm of Intra-abdominal Lymph Nodes, run by Samsung Medical Center 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 3 inclusion and 4 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 17 May 2011. 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?
Compare the degree of cytologic quality in specimen obtained by EUS-FNA with or without suction, pushing the stylet or injecting air. (time frame: within 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01354795, which also lists 1 linked publication.
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 17 May 2011.