22G FNA Needle vs. 22G ProCore Needle

Not Applicable

Completed

• Conditions: Pancreatic Neoplasm
• Interventions: Procedure: 22G ProCore biopsy needle; Procedure: 22G standard FNA needle

• Registration Number: NCT01394159
• Lead Sponsor: AdventHealth

Brief Summary

The aim of this research study is to identify the best needle for performing biopsy during EUS procedures. There are two types of needles for performing biopsy: A FNA needle that provides a small sample of tissue for analysis and a 22G ProCore needle that provides larger amount of tissue. It is not clear at this point which of the two needles is superior for performing biopsy. This study will attempt to identify the better needle by assessing the performance of both needles in a randomized fashion.

Detailed Description

In this randomized trial, the 22G standard fine needle aspiration needle was compared with the newly developed 22G ProCore needle for sampling pancreatic mass lesions during endoscopic ultrasound. Patients were randomized into the two needle groups and then various outcomes were compared between the two needle types, including the number of passes needed to establish a diagnosis, the ability to procure enough tissue sample to be able to make a diagnosis, the rates of needle failure and complication rates.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-12
• Study First Submitted QC: 2011-07-13
• Study First Posted: 2011-07-14
• Primary Completion: 2011-09
• Study Completion: 2011-12
• Results First Submitted: 2015-03-18
• Results First Submitted QC: 2015-03-30
• Results First Posted: 2015-04-01
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-09
• Last Update Posted: 2018-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

-All patients with solid pancreatic mass lesions

Exclusion Criteria

• Coaguloapthy,
• minors,
• prgenant patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
22G ProCore biopsy needle	22G ProCore biopsy needle	Using the 22G ProCore needle for sampling pancreatic mass lesions, the tissue obtained will be compared to the standard FNA needle.
22G standard FNA needle	22G standard FNA needle	Using the 22G standard fine needle aspiration needle (FNA) for sampling pancreatic mass lesions, the tissue obtained will be compared to the 22 G ProCore needle.

Primary Outcome Measures

Name	Time	Method
Compare the Median Number of Passes Required to Establish a Diagnosis	6 months

Secondary Outcome Measures

Name	Time	Method
Diagnosis Achieved With the Needle	6 months
Technical Failure	6 months	Malfunction of the needle during endoscopic ultrasound-guided sampling of the pancreatic mass lesion before a diagnosis is achieved

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States