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

NCT ID: NCT01978808

Last Updated: 2013-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-08-31

Brief Summary

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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

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 There have been preliminary unpublished retrospective data that suggested the yield might be raised.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

Conditions

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Pancreatic Tumor

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tsu-Yao Cheng

Role: PRINCIPAL_INVESTIGATOR

Visiting staff

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Tsu-Yao Cheng

Role: CONTACT

Phone: +886-2-23123456

Email: [email protected]

Facility Contacts

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Tsu-Yao Cheng

Role: primary

Other Identifiers

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201307045RINC

Identifier Type: -

Identifier Source: org_study_id