EUS-FNANCT01923883
Comparison of EUS-Guided Fine Needle Aspiration Technique
A study testing EUS-FNA and Echoendoscope Olympus GF-UCT240 in people with EUS-FNA and Cytodiagnosis, run by Asan Medical Center at 1 site in South Korea.
Trial summary
EUS-guided fine needle aspiration (EUS-FNA) is a safe and effective method for diagnosing pancreatic and peripancreatic solid masses. The aim of this study is to compare the two aspiration methods in EUS-FNA: negative-pressure suction with syringe vs. capillary sampling with stylet slow-pull technique. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- EUS-FNA, Cytodiagnosis
- What is being tested?
- EUS-FNA and Echoendoscope Olympus GF-UCT240
- 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
- 51 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2013to Jun 2014
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients with pancreatic solid mass which requires EUS-FNA for diagnosis
- Informed consent is obtained
Who cannot join
- Age < 20 years
- Active gastrointestinal bleeding
- Bleeding tendency (platelet < 50,000/mm3 and/or PT INR > 1.5)
- Unable to understand and/or read the informed consent.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 138-736
Do Hyun Park, MD, PhD, +82230103194, dhpark@amc.seoul.kr
About this study
Official title: Comparison of EUS-guided Fine Needle Aspiration Technique: Negative-pressure Suction With Syringe vs. Capillary Sampling With Stylet Slow-pull Technique
EUS-guided fine needle aspiration (EUS-FNA) is a safe and effective method for diagnosing pancreatic and peripancreatic solid masses. The aim of this study is to compare the two aspiration methods in EUS-FNA: negative-pressure suction with syringe vs. capillary sampling with stylet slow-pull technique. We will evaluate the diagnostic adequacy and accuracy of the specimens obtained by EUS-FNA with two aspiration methods.
Read the detailed description
EUS-guided fine needle aspiration (EUS-FNA) is a safe and effective method for diagnosing pancreatic and peripancreatic solid masses. The diagnostic accuracy of EUS-FNA has been reported to be 62-96%. There are two aspiration methods for obtaining specimens with EUS needle, application of a negative-pressure syringe and capillary sampling (without suction).
The former method is thought to increase cellularity of obtained specimen. However, a negative-pressure syringe can worsen the specimen quality by increasing the amount of bloody material in the specimen and damaging the tissue. Blood in the aspirate dilutes the sample and makes direct smears more difficult to interpret because clots form.
Meanwhile, the latter method might yield a small sample with a high diagnostic yield because of a decreased amount of sanguineous staining. Recently, EUS-guided fine needle biopsy with 22-gauge ProCore needle using capillary sampling while removing the stylet slowly for 40 sec during the to-and-fro movement of the needle (capillary sampling with style slow-pull technique) for pancreas biopsy was reported to provide significantly higher tissue adequacy compared to half- (5 mL) or full suction (10 mL) methods in animal study.
Therefore, we will perform the prospective randomized clinical trial comparing the diagnostic adequacy and accuracy of the specimens obtained by two different aspiration methods in EUS-FNA: negative-pressure suction with syringe (NPS) vs. capillary sampling with stylet slow-pull technique (CSS).
The primary end point of this study is to evaluate the difference of diagnostic accuracy between two aspiration methods. This study is a prospective randomized clinical trial. The needle used in this study is a conventional EUS-FNA needle (Echotip, Cook Medical, Winston-Salem, NC) approved by the FDA and Korea Food and Drug Administration (KFDA).
The procedure will be performed by one endoscopist. The patients will undergo EUS-FNA under conscious sedation with midazolam and meperidine. The procedure is same as conventional EUS-FNA except the aspiration method. The first aspiration method (NPS or CSS) will be assigned by random number table. After first needle passage, the next EUS-FNA will be done by different aspiration method. A total of four times of needle passes will be performed in each patient with alternative aspiration methods (i.e., NPS and CSS each two times in one patient).
Sample size
- We Assumed that the diagnostic accuracy of two aspiration methods (NPS and CSS) are equivalent (88%) and the non-inferiority margin is 10%.
- A two-tailed sample size calculation was performed with 1% alpha error to attain 80% power. Using a 10% dropout rate, the target sample size was 51 (i.e., NPS and CSS each 102 times in 51 patients).
Statistical analyses
- Chi-square test - Comparing the specimen adequacy of 1st needle pass according to the aspiration methods.
- Student's t-test - Number of needle passes for optimal specimen and for accurate diagnosis.
- McNemar test - Comparing the diagnostic yields according to the aspiration methods.
- Sensitivity, specificity, accuracy, positive and negative predictive values.
- Conditions
- EUS-FNA, Cytodiagnosis
- Being tested
- EUS-FNA, Echoendoscope Olympus GF-UCT240
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-FNAProcedure or surgery
EUS-guided fine needle aspiration will be performed by a single experienced endoscopist (D.H.P) using a conventional linear array echoendoscope (GF-UCT240, Olympus Optical Tokyo, Japan) under conscious sedation with midazolam and meperidine. After the optimal puncture site was determined, a puncture will be done using a 22-gauge EchoTip needle (Cook Endoscopy, Winston-Salem, NC) guided by real-time EUS imaging. Subsequently, the stylet will be slowly removed as the needle is moved to-and-fro for 15 times (capillary sampling method with stylet slow-pull technique) or negative-pressure 10 mL syringe will be applied (negative-pressure syringe suction). A total of 4 needle passes will be done for the lesion with using above two aspiration methods alternatively.
Echoendoscope Olympus GF-UCT240Device
| Study group | Role | What they receive |
|---|---|---|
| Negative-pressure syringe | Active comparator | EUS-FNA with negative-pressure suction with syringe Receives: Procedure: EUS-FNA; Device: Echoendoscope Olympus GF-UCT240 |
| Capillary sampling with slow-pull | Experimental | EUS-FNA with capillary sampling with stylet slow-pull technique Receives: Procedure: EUS-FNA; Device: Echoendoscope Olympus GF-UCT240 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of true positive or true negative results in pathology
Compare the two groups (NPS vs. CSS) with the pathologic accuracy (rate of true positive or true negative) by EUS-FNA.
Measured: The pathologic results will be reported within 7 days 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 posted16 Aug 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EUS-FNAStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (estimated)
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, University of Ulsan College of Medicine, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923883
- Sponsor's protocol ID
- EUSFNA20130574
- Status last verified
- Aug 2013
- First submitted
- 12 Aug 2013
- Last updated
- 16 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of EUS-guided Fine Needle Aspiration Technique: Negative-pressure Suction With Syringe vs. Capillary Sampling With Stylet Slow-pull Technique
- ClinicalTrials.gov ID
- NCT01923883
- Acronym / sponsor ID
- EUSFNA20130574
- Conditions
- EUS-FNA, Cytodiagnosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 16 Aug 2013 (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 fine needle aspiration (EUS-FNA) is a safe and effective method for diagnosing pancreatic and peripancreatic solid masses. The aim of this study is to compare the two aspiration methods in EUS-FNA: negative-pressure suction with syringe vs. capillary sampling with stylet slow-pull technique. We will evaluate the diagnostic adequacy and accuracy of the specimens obtained by EUS-FNA with two aspiration methods.
Detailed description
EUS-guided fine needle aspiration (EUS-FNA) is a safe and effective method for diagnosing pancreatic and peripancreatic solid masses. The diagnostic accuracy of EUS-FNA has been reported to be 62-96%. There are two aspiration methods for obtaining specimens with EUS needle, application of a negative-pressure syringe and capillary sampling (without suction).
The former method is thought to increase cellularity of obtained specimen. However, a negative-pressure syringe can worsen the specimen quality by increasing the amount of bloody material in the specimen and damaging the tissue. Blood in the aspirate dilutes the sample and makes direct smears more difficult to interpret because clots form.
Meanwhile, the latter method might yield a small sample with a high diagnostic yield because of a decreased amount of sanguineous staining. Recently, EUS-guided fine needle biopsy with 22-gauge ProCore needle using capillary sampling while removing the stylet slowly for 40 sec during the to-and-fro movement of the needle (capillary sampling with style slow-pull technique) for pancreas biopsy was reported to provide significantly higher tissue adequacy compared to half- (5 mL) or full suction (10 mL) methods in animal study.
Therefore, we will perform the prospective randomized clinical trial comparing the diagnostic adequacy and accuracy of the specimens obtained by two different aspiration methods in EUS-FNA: negative-pressure suction with syringe (NPS) vs. capillary sampling with stylet slow-pull technique (CSS).
The primary end point of this study is to evaluate the difference of diagnostic accuracy between two aspiration methods. This study is a prospective randomized clinical trial. The needle used in this study is a conventional EUS-FNA needle (Echotip, Cook Medical, Winston-Salem, NC) approved by the FDA and Korea Food and Drug Administration (KFDA).
The procedure will be performed by one endoscopist. The patients will undergo EUS-FNA under conscious sedation with midazolam and meperidine. The procedure is same as conventional EUS-FNA except the aspiration method. The first aspiration method (NPS or CSS) will be assigned by random number table. After first needle passage, the next EUS-FNA will be done by different aspiration method. A total of four times of needle passes will be performed in each patient with alternative aspiration methods (i.e., NPS and CSS each two times in one patient).
Sample size
- We Assumed that the diagnostic accuracy of two aspiration methods (NPS and CSS) are equivalent (88%) and the non-inferiority margin is 10%.
- A two-tailed sample size calculation was performed with 1% alpha error to attain 80% power. Using a 10% dropout rate, the target sample size was 51 (i.e., NPS and CSS each 102 times in 51 patients).
Statistical analyses
- Chi-square test - Comparing the specimen adequacy of 1st needle pass according to the aspiration methods.
- Student's t-test - Number of needle passes for optimal specimen and for accurate diagnosis.
- McNemar test - Comparing the diagnostic yields according to the aspiration methods.
- Sensitivity, specificity, accuracy, positive and negative predictive values.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative-pressure syringe | Active comparator | Procedure: EUS-FNA, Device: Echoendoscope Olympus GF-UCT240EUS-FNA with negative-pressure suction with syringe |
| Capillary sampling with slow-pull | Experimental | Procedure: EUS-FNA, Device: Echoendoscope Olympus GF-UCT240EUS-FNA with capillary sampling with stylet slow-pull technique |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The patients with pancreatic solid mass which requires EUS-FNA for diagnosis
- Informed consent is obtained
Key exclusion criteria (4 listed)
- Age < 20 years
- Active gastrointestinal bleeding
- Bleeding tendency (platelet < 50,000/mm3 and/or PT INR > 1.5)
- Unable to understand and/or read the 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 |
|---|---|---|
| EUS-FNAEUS-guided fine needle aspiration will be performed by a single experienced endoscopist (D.H.P) using a conventional linear array echoendoscope (GF-UCT240, Olympus Optical Tokyo, Japan) under conscious sedation with midazolam and meperidine. After the optimal puncture site was determined, a puncture will be done using a 22-gauge EchoTip needle (Cook Endoscopy, Winston-Salem, NC) guided by real-time EUS imaging. Subsequently, the stylet will be slowly removed as the needle is moved to-and-fro for 15 times (capillary sampling method with stylet slow-pull technique) or negative-pressure 10 mL syringe will be applied (negative-pressure syringe suction). A total of 4 needle passes will be done for the lesion with using above two aspiration methods alternatively. | Procedure or surgery | Capillary sampling with slow-pull, Negative-pressure syringe |
| Echoendoscope Olympus GF-UCT240 | Device | Capillary sampling with slow-pull, Negative-pressure syringe |
Primary outcome
Rate of true positive or true negative results in pathology
Time frame: The pathologic results will be reported within 7 days after EUS-FNA.
Compare the two groups (NPS vs. CSS) with the pathologic accuracy (rate of true positive or true negative) by EUS-FNA.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2013.
Related trials for EUS-FNA
Not yet recruiting
Feasibility of the Loop Brush EUS-FNA for Characterization of Pancreatic Cysts: Pilot Clinical Investigation
Pancreatic Cancer
Active, not recruitingObservational study
AI for Onsite Cytology Evaluation in Endoscopic Ultrasound
Gastrointestinal Neoplasm, Mass Lesion
Recruiting
MCB vs EUS-FNA for Preoperative Pathological Evaluation of Gastric SMT
Gastrointestinal Stromal Tumor of Stomach, Submucosal Tumor of Stomach
RecruitingObservational study
Anatomical-Clinical Base of Adenocarcinoma Pancreatic
Adenocarcinoma, Carcinoma
RecruitingObservational study
EUS-guided FNB-induced PANCREatitis Assessment
Pancreatitis, Acute, EUS Guided Biopsy
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
University of Ulsan College of Medicine, 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 study testing EUS-FNA and Echoendoscope Olympus GF-UCT240 in people with EUS-FNA and Cytodiagnosis, 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 2 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: status not confirmed, as of the sponsor's last update on 16 Aug 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of true positive or true negative results in pathology (time frame: The pathologic results will be reported within 7 days 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 16 Aug 2013.