Comparison of EUS-Guided Fine Needle Aspiration Technique
NCT ID: NCT01923883
Last Updated: 2013-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
51 participants
INTERVENTIONAL
2013-06-30
2014-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
1. We Assumed that the diagnostic accuracy of two aspiration methods (NPS and CSS) are equivalent (88%) and the non-inferiority margin is 10%.
2. 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
1. Chi-square test - Comparing the specimen adequacy of 1st needle pass according to the aspiration methods.
2. Student's t-test - Number of needle passes for optimal specimen and for accurate diagnosis.
3. McNemar test - Comparing the diagnostic yields according to the aspiration methods.
4. Sensitivity, specificity, accuracy, positive and negative predictive values.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
DIAGNOSTIC
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Negative-pressure syringe
EUS-FNA with negative-pressure suction with syringe
EUS-FNA
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-UCT240
Capillary sampling with slow-pull
EUS-FNA with capillary sampling with stylet slow-pull technique
EUS-FNA
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-UCT240
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
EUS-FNA
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-UCT240
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Informed consent is obtained
Exclusion Criteria
* Active gastrointestinal bleeding
* Bleeding tendency (platelet \< 50,000/mm3 and/or PT INR \> 1.5)
* Unable to understand and/or read the informed consent.
20 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Asan Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Do Hyun Park
Associate professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Do Hyun Park, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Ulsan College of Medicine, Asan Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Asan Medical Center
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Do Hyun Park, MD, PhD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EUSFNA20130574
Identifier Type: -
Identifier Source: org_study_id