22G FNA Needle vs. 22G ProCore Needle

This study has been completed.
Information provided by (Responsible Party):
Shyam Varadarajulu, Florida Hospital
ClinicalTrials.gov Identifier:
First received: July 12, 2011
Last updated: March 30, 2015
Last verified: March 2015
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 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.

Condition Intervention
Pancreatic Neoplasm
Procedure: 22G Procore biopsy needle
Procedure: 22G FNA needle

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Randomized Trial Comparing the 22-gauge Aspiration and 22-gauge Biopsy Needles for EUS-guided Sampling of Solid Pancreatic Mass Lesions

Resource links provided by NLM:

Further study details as provided by Florida Hospital:

Primary Outcome Measures:
  • Compare the Median Number of Passes Required to Establish a Diagnosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diagnosis Achieved With the Needle [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Technical Failure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Malfunction of the needle during endoscopic ultrasound-guided sampling of the pancreatic mass lesion before a diagnosis is achieved

Enrollment: 56
Study Start Date: July 2011
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 22G ProCore needle
Use the 22G ProCore needle for sampling pancreatic mass lesions
Procedure: 22G Procore biopsy needle
Acquire tissue with the 22G Procore biopsy needle
Other Name: Acquire tissue with ProCore needle
Active Comparator: 22G standard FNA needle
Use the 22G standard find needle aspiration needle (FNA) for sampling pancreatic mass lesions
Procedure: 22G FNA needle
Acquire tissue with the 22G FNA needle

Detailed Description:
In this randomized trial, the 22G 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.

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

-All patients with solid pancreatic mass lesions

Exclusion Criteria:

  • Coaguloapthy,
  • minors,
  • prgenant patients
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01394159

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
Shyam Varadarajulu
Principal Investigator: Shyam Varadarajulu, MD University of Alabama at Birmingham
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shyam Varadarajulu, Principal Investigator, Florida Hospital
ClinicalTrials.gov Identifier: NCT01394159     History of Changes
Other Study ID Numbers: F110506010 
Study First Received: July 12, 2011
Results First Received: March 18, 2015
Last Updated: March 30, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Florida Hospital:
passes required to establish diagnosis

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

ClinicalTrials.gov processed this record on May 26, 2016