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

Pancreatic Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01978808
• Other study ID #: 201307045RINC
• Status: Recruiting
• Phase: N/A
• First received: October 16, 2013
• Last updated: November 11, 2013
• Start date: October 2013
• Est. completion date: August 2016

Study information

• Verified date: November 2013
• Source: National Taiwan University Hospital
• Contact: Tsu-Yao Cheng
• Phone: +886-2-23123456
• Email: tycheng[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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 There have been preliminary unpublished retrospective data that suggested the yield might be raised.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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pancreatic Neoplasms
• Pancreatic Tumor

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the overall diagnostic accuracy rate of both needles		assessment of diagnostic accuracy rate after 26 wks, then annually later	No