Pancreatic MassesPhase 3NCT01576497
Optimal Number of To-and-fro Motion in EUS-guided Fine Needle Aspiration for Pancreatic Masses
A Phase 3 study testing EUS-FNA, EUS-FNA with suction and EUS-FNA without suction in people with Pancreatic Masses, run by Asan Medical Center at 1 site in South Korea.
Trial summary
EUS-FNA is the standard of care for diagnosing pancreatic masses. According to the operator's preference, EUS-FNA with suction or without suction technique has been used. To date, little is known about optimal number of to-and-fro motion during each needle pass. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pancreatic Masses
- What is being tested?
- EUS-FNA, EUS-FNA with suction and EUS-FNA without suction
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2012to Mar 2013
- Phase
- Phase 3
- 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 > 19 years Solid pancreatic mass lesions
Who cannot join
- Age < 19 years Coagulopathy Unable to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimal Number of To-and-fro Motion in EUS-guided Fine Needle Aspiration for Pancreatic Masses in Terms of Suction or Without Suction: Prospective Randomized Single Blinded Trial
EUS-FNA is the standard of care for diagnosing pancreatic masses. According to the operator's preference, EUS-FNA with suction or without suction technique has been used. To date, little is known about optimal number of to-and-fro motion during each needle pass. As usual 10-15 to-and-fro motions was used for EUS-FNA with suction technique. Theoretically, more number of to-and-fro motions may be required in EUS-FNA without suction. In this circumstance, the contamination of blood in specimen and possible adverse event may occur. To determine optimal number of to-and-fro motion in EUS-guided FNA for pancreatic masses in terms of with suction or without suction, this prospective single-blinded randomized trial was conducted.
Read the detailed description
For this prospective single-blinded randomized trial, two 10cc syringes was prepared. Two syringe was provided as same performance. However, one syringe is falsely made as suction syringe (fake one). During EUS-FNA, two syringe is randomly assigned and loaded by a nurse. Thus, operator was blinded which syringe is with suction or without suction.
First hypothesis: There is difference in the diagnostic accuracy of pancreatic masses according to EUS-FNA with suction or without suction/ different number of to-and-fro motion.
Second hypothesis: There is difference in the amount of blood in samples obtained by EUS-FNA with suction or without suction/ different number of to-and-fro motion.
- Conditions
- Pancreatic Masses
- Being tested
- EUS-FNA, EUS-FNA with suction, EUS-FNA without suction
- Keywords
- EUS, EUS-FNA, Pancreatic masses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-FNAProcedure or surgery
Also called FNA with or without suction
EUS-FNA with suction/10, 15, 20 to-and-fro motion vs. EUS-FNA without suction/10, 15, 20 to-and-fro motion Visual assessment as stoping rule: 20 to-and-fro motion at different site will be performed when EUS-FNA sampling with 10, 15, 20 to-and-fro motion is unsatisfactory.
EUS-FNA with suctionDevice
Also called FNA with suction
For this prospective single-blinded randomized trial, two 10cc syringes was prepared. Two syringe was provided as same performance. However, one syringe is falsely made as suction syringe (fake one). During EUS-FNA, two syringe is randomly assigned and loaded by a nurse. Thus, operator was blinded which syringe is with suction or without suction.
EUS-FNA without suctionDevice
Also called FNA without suction
For this prospective single-blinded randomized trial, two 10cc syringes was prepared. Two syringe was provided as same performance. However, one syringe is falsely made as suction syringe (fake one). During EUS-FNA, two syringe is randomly assigned and loaded by a nurse. Thus, operator was blinded which syringe is with suction or without suction.
| Study group | Role | What they receive |
|---|---|---|
| EUS-FNA with suction | Active comparator | EUS-FNA with suction/10, 15, 20 to-and-fro motion vs. EUS-FNA with suction/10, 15, 20 to-and-fro motion Visual assessment as stoping rule: 20 to-and-fro motion at different site will be performed when EUS-FNA sampling with 10, 15, 20 to-and-fro motion is unsatisfactory. Receives: Device: EUS-FNA with suction |
| EUS-FNA without suction | Active comparator | EUS-FNA with suction/10, 15, 20 to-and-fro motion vs. EUS-FNA without suction/10, 15, 20 to-and-fro motion Visual assessment as stoping rule: 20 to-and-fro motion at different site will be performed when EUS-FNA sampling with 10, 15, 20 to-and-fro motion is unsatisfactory. Receives: Procedure: EUS-FNA; Device: EUS-FNA without suction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
The diagnostic accuracy of pancreatic masses at each sample according to EUS-FNA with suction or without suction/ different number of to-and-fro motion will be measured.
Diagnostic accuracy of EUS-FNA with suction and 10, 15, and 20 to-and-fro motion vs.Diagnostic accuracy of EUS-FNA without suction and 10, 15, and 20 to-and-fro motion.
Measured: 1 year
Secondary outcomes (1)
Blood contamination in each sample
The amount of blood contamination at each sample according to EUS-FNA with suction or without suction/ different number of to-and-fro motion will be measured.
The amount of blood contamination of EUS-FNA with suction and 10, 15, and 20 to-and-fro motion vs. The amount of blood contamination of EUS-FNA without suction and 10, 15, and 20 to-and-fro motion.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic MassesStudies of the same condition, open and under way.
- More trials run by Asan 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Do Hyun Park, Asan Medical Center
- Investigators
- Do Hyun Park, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576497
- Sponsor's protocol ID
- 2012-0018
- Status last verified
- Apr 2012
- First submitted
- 7 Apr 2012
- Last updated
- 29 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Number of To-and-fro Motion in EUS-guided Fine Needle Aspiration for Pancreatic Masses in Terms of Suction or Without Suction: Prospective Randomized Single Blinded Trial
- ClinicalTrials.gov ID
- NCT01576497
- Acronym / sponsor ID
- 2012-0018
- Conditions
- Pancreatic Masses
- Keywords
- EUS, EUS-FNA, Pancreatic masses
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 12 Apr 2012 (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-FNA is the standard of care for diagnosing pancreatic masses. According to the operator's preference, EUS-FNA with suction or without suction technique has been used. To date, little is known about optimal number of to-and-fro motion during each needle pass. As usual 10-15 to-and-fro motions was used for EUS-FNA with suction technique. Theoretically, more number of to-and-fro motions may be required in EUS-FNA without suction. In this circumstance, the contamination of blood in specimen and possible adverse event may occur. To determine optimal number of to-and-fro motion in EUS-guided FNA for pancreatic masses in terms of with suction or without suction, this prospective single-blinded randomized trial was conducted.
Detailed description
For this prospective single-blinded randomized trial, two 10cc syringes was prepared. Two syringe was provided as same performance. However, one syringe is falsely made as suction syringe (fake one). During EUS-FNA, two syringe is randomly assigned and loaded by a nurse. Thus, operator was blinded which syringe is with suction or without suction.
First hypothesis: There is difference in the diagnostic accuracy of pancreatic masses according to EUS-FNA with suction or without suction/ different number of to-and-fro motion.
Second hypothesis: There is difference in the amount of blood in samples obtained by EUS-FNA with suction or without suction/ different number of to-and-fro motion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS-FNA with suction | Active comparator | Device: EUS-FNA with suctionEUS-FNA with suction/10, 15, 20 to-and-fro motion vs. EUS-FNA with suction/10, 15, 20 to-and-fro motion Visual assessment as stoping rule: 20 to-and-fro motion at different site will be performed when EUS-FNA sampling with 10, 15, 20 to-and-fro motion is unsatisfactory. |
| EUS-FNA without suction | Active comparator | Procedure: EUS-FNA, Device: EUS-FNA without suctionEUS-FNA with suction/10, 15, 20 to-and-fro motion vs. EUS-FNA without suction/10, 15, 20 to-and-fro motion Visual assessment as stoping rule: 20 to-and-fro motion at different site will be performed when EUS-FNA sampling with 10, 15, 20 to-and-fro motion is unsatisfactory. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age > 19 years Solid pancreatic mass lesions
Key exclusion criteria (1 listed)
- Age < 19 years Coagulopathy Unable to 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 |
|---|---|---|
| EUS-FNAAlso: FNA with or without suctionEUS-FNA with suction/10, 15, 20 to-and-fro motion vs. EUS-FNA without suction/10, 15, 20 to-and-fro motion Visual assessment as stoping rule: 20 to-and-fro motion at different site will be performed when EUS-FNA sampling with 10, 15, 20 to-and-fro motion is unsatisfactory. | Procedure or surgery | EUS-FNA without suction |
| EUS-FNA with suctionAlso: FNA with suctionFor this prospective single-blinded randomized trial, two 10cc syringes was prepared. Two syringe was provided as same performance. However, one syringe is falsely made as suction syringe (fake one). During EUS-FNA, two syringe is randomly assigned and loaded by a nurse. Thus, operator was blinded which syringe is with suction or without suction. | Device | EUS-FNA with suction |
| EUS-FNA without suctionAlso: FNA without suctionFor this prospective single-blinded randomized trial, two 10cc syringes was prepared. Two syringe was provided as same performance. However, one syringe is falsely made as suction syringe (fake one). During EUS-FNA, two syringe is randomly assigned and loaded by a nurse. Thus, operator was blinded which syringe is with suction or without suction. | Device | EUS-FNA without suction |
Primary outcome
Diagnostic accuracy
Time frame: 1 year
The diagnostic accuracy of pancreatic masses at each sample according to EUS-FNA with suction or without suction/ different number of to-and-fro motion will be measured. Diagnostic accuracy of EUS-FNA with suction and 10, 15, and 20 to-and-fro motion vs.Diagnostic accuracy of EUS-FNA without suction and 10, 15, and 20 to-and-fro motion.
1 secondary outcome
Blood contamination in each sample
Time frame: 1 year
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 29 May 2014.
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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.
Do Hyun Park, MD, PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EUS-FNA, EUS-FNA with suction and EUS-FNA without suction in people with Pancreatic Masses, run by Asan 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 1 inclusion and 1 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 29 May 2014. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Diagnostic accuracy (time frame: 1 year). 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 29 May 2014.