Efficiency Study of the EUS-FNA Needles With and Without a Side Port in Pancreatic Masses

A Prospective Multi-center Randomized Study of the Difference in Diagnostic Yield Between EUS-FNA Needles With and Without a Side Port in Pancreatic Masses

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01978808

Enrollment

200

Registered

2013-11-08

Start date

2013-10-31

Completion date

2016-08-31

Last updated

2013-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Tumor

Brief summary

For diagnosis of pancreatic tumors, endoscopic ultrasound (EUS) and EUS-guided fine needle aspiration (EUS-FNA) are well established techniques in clinical practice. We hypothesize that a FNA needle with a side port could improve the diagnostic yield. The aim of this prospective randomized study is to determine whether there is a difference in diagnostic yield in patients with pancreatic masses for evaluation.

Detailed description

For diagnosis of pancreatic tumors, endoscopic ultrasound (EUS) and EUS-guided fine needle aspiration (EUS-FNA) are well established techniques in clinical practice. In the case of EUS, an ultrasonic transducer located at the tip of the echoendoscope allows the endoscopist to visualize the wall of gastrointestinal tract as a series of definable layers corresponding to histology, and also enables detailed images of areas outside of the digestive tract. EUS has a significant clinical impact because it allows assessment of submucosal GI lesions, loco-regional staging of gastrointestinal malignancy, tissue diagnosis by EUS-FNA and staging of pancreaticobiliary lesions, non-small-cell lung carcinoma, and mediastinal disease. In prospective trials, EUS-FNA has been clearly established to be an important diagnostic tool with excellent safety profile. Olympus has recently made commercially available a new 22 gauge FNA needle with a side port at the needle tip to facilitate the process of FNA and increase the diagnostic yield. There have been preliminary unpublished retrospective data that suggested the yield might be raised. However, there are no prospective multicenter randomized controlled studies to ascertain the validity of the assumption. The aim of this prospective randomized study is to determine whether there is a difference in diagnostic yield between EZ-Shot 2 (model: NA-220H-8022) and EZ-Shot 2 with side port (NA-230H-8022) in patients with pancreatic masses for evaluation. We hypothesize that a FNA needle with a side port could improve the diagnostic yield.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 90 Years

Healthy volunteers

Inclusion criteria

1. all patients referred for EUS-FNA of pancreatic masses; 2. informed consent is obtained for performance of EUS-FNA.

Exclusion criteria

1\. presence of active gastrointestinal bleeding

Design outcomes

Primary

Measure	Time frame
the overall diagnostic accuracy rate of both needles	assessment of diagnostic accuracy rate after 26 wks, then annually later

Countries

Taiwan

Contacts

Primary ContactTsu-Yao Cheng

tycheng@ntu.edu.tw+886-2-23123456

Outcome results