Comparison of EUS-guided Fine Needle Aspiration Technique: Negative-pressure Suction With Syringe vs. Capillary Sampling With Stylet Slow-pull Technique
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Asan Medical Center
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Rate of true positive or true negative results in pathology
Study Overview
Brief 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. 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The patients with pancreatic solid mass which requires EUS-FNA for diagnosis
- •Informed consent is obtained
Exclusion Criteria
- •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.
Arms & Interventions
Negative-pressure syringe
EUS-FNA with negative-pressure suction with syringe
Intervention: EUS-FNA (Procedure)
Negative-pressure syringe
EUS-FNA with negative-pressure suction with syringe
Intervention: Echoendoscope Olympus GF-UCT240 (Device)
Capillary sampling with slow-pull
EUS-FNA with capillary sampling with stylet slow-pull technique
Intervention: Echoendoscope Olympus GF-UCT240 (Device)
Capillary sampling with slow-pull
EUS-FNA with capillary sampling with stylet slow-pull technique
Intervention: EUS-FNA (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Do Hyun Park
Associate professor
Asan Medical Center
