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

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ClinicalTrials.gov Identifier: NCT01978808
Recruitment Status : Unknown
Verified November 2013 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : November 8, 2013
Last Update Posted : November 13, 2013
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease
Pancreatic Tumor

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 There have been preliminary unpublished retrospective data that suggested the yield might be raised.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


Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Study Start Date : October 2013
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016



Primary Outcome Measures :
  1. the overall diagnostic accuracy rate of both needles [ Time Frame: assessment of diagnostic accuracy rate after 26 wks, then annually later ]


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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients referred for EUS-FNA of pancreatic masses
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01978808


Contacts
Contact: Tsu-Yao Cheng +886-2-23123456 ext 65757 tycheng@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Tsu-Yao Cheng    +886-2-23123456 ext 65757    tycheng@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Tsu-Yao Cheng Visiting staff

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01978808     History of Changes
Other Study ID Numbers: 201307045RINC
First Posted: November 8, 2013    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases