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Clinical Trials/NCT01923883
NCT01923883UnknownNot Applicable

Comparison of EUS-guided Fine Needle Aspiration Technique: Negative-pressure Suction With Syringe vs. Capillary Sampling With Stylet Slow-pull Technique

Asan Medical Center1 site in 1 country51 target enrollmentStarted: June 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
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

Active Comparator

EUS-FNA with negative-pressure suction with syringe

Intervention: EUS-FNA (Procedure)

Negative-pressure syringe

Active Comparator

EUS-FNA with negative-pressure suction with syringe

Intervention: Echoendoscope Olympus GF-UCT240 (Device)

Capillary sampling with slow-pull

Experimental

EUS-FNA with capillary sampling with stylet slow-pull technique

Intervention: Echoendoscope Olympus GF-UCT240 (Device)

Capillary sampling with slow-pull

Experimental

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Do Hyun Park

Associate professor

Asan Medical Center

Study Sites (1)

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