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22G FNA Needle vs. 22G ProCore Needle

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01394159
First Posted: July 14, 2011
Last Update Posted: April 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shyam Varadarajulu, Florida Hospital
  Purpose
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
Intervention Model: Parallel Assignment
Masking: None (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 Shyam Varadarajulu, Florida Hospital:

Primary Outcome Measures:
  • Compare the Median Number of Passes Required to Establish a Diagnosis [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Diagnosis Achieved With the Needle [ Time Frame: 6 months ]
  • Technical Failure [ Time Frame: 6 months ]
    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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-All patients with solid pancreatic mass lesions

Exclusion Criteria:

  • Coaguloapthy,
  • minors,
  • prgenant patients
  Contacts and Locations
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): NCT01394159


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
Shyam Varadarajulu
Investigators
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
First Submitted: July 12, 2011
First Posted: July 14, 2011
Results First Submitted: March 18, 2015
Results First Posted: April 1, 2015
Last Update Posted: April 1, 2015
Last Verified: March 2015

Keywords provided by Shyam Varadarajulu, Florida Hospital:
passes required to establish diagnosis

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