Comparison of EUS-Guided Fine Needle Aspiration Technique

NCT01923883 | Unknown

• 1 other identifier: EUSFNA20130574
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

EUS-FNA; Cytodiagnosis

Outcome Measures

Primary Outcomes (1)

• 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.

  The pathologic results will be reported within 7 days after EUS-FNA.

Study Arms (2)

Negative-pressure syringe

ACTIVE COMPARATOR

EUS-FNA with negative-pressure suction with syringe

Procedure: EUS-FNA; Device: Echoendoscope Olympus GF-UCT240

Capillary sampling with slow-pull

EXPERIMENTAL

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

Procedure: EUS-FNA; Device: Echoendoscope Olympus GF-UCT240

Interventions

EUS-FNA PROCEDURE

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.

Capillary sampling with slow-pull; Negative-pressure syringe

Echoendoscope Olympus GF-UCT240 DEVICE

Capillary sampling with slow-pull; Negative-pressure syringe

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients with pancreatic solid mass which requires EUS-FNA for diagnosis
• Informed consent is obtained

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

RECRUITING

MeSH Terms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Do Hyun Park, MD, PhD

  University of Ulsan College of Medicine, Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 12, 2013
• First Posted: August 16, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 16, 2013

Record last verified: 2013-08

Locations

KR (1)