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Trial Comparing 19 and 25-gauge EUS-FNA Needles

This study has been completed.
Sponsor:
Collaborator:
University of Alabama at Birmingham
Information provided by (Responsible Party):
Florida Hospital
ClinicalTrials.gov Identifier:
NCT01677312
First received: August 28, 2012
Last updated: March 12, 2013
Last verified: March 2013
History of Changes
  Purpose

This study compares the 19G and 25G needles for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures.


Condition Intervention
Solid Pancreatic Mass Lesions
 Procedure: Pancreatic Biopsy
Procedure: Histological Samples

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Multi-Center Randomized Trial Comparing 19 and 25-gauge Needles for Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) of Solid Pancreatic Mass Lesions

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by Florida Hospital:

Primary Outcome Measures:
  • Median number of passes to establish diagnosis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To compare the median number of passes required to establish diagnosis using the 19G and 25G needles for FNA of solid pancreatic mass lesions. This will be measured by comparing the rates of diagnostic accuracy (%) between both needle types.


Secondary Outcome Measures:
  • Procurement of histological samples [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    The ability of the 19G and 25G needles to obtain core (histological) tissue will be compared as percentages (%) and a significance will be determined.

  • Needle dysfunction [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    The proportion of cases (%) in which needle dysfunction occurs will be compared between the 19G and 25G needle types. Needle dysfunction will be defined as the need to use more than one FNA needle per lesion in an individual patient.

  • Complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    The safety profile of the 19 and 25G needles will be compared as rates of complication (%) that includes bleeding, pancreatitis and perforation.


Enrollment: 109
Study Start Date: August 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 19G FNA needle
Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 19G FNA needle when performing pancreatic biopsy.
 Procedure: Pancreatic Biopsy
A FNA needle will be used to biopsy the pancreatic mass. The rates of diagnostic accuracy (%) will be assessed. Diagnostic accuracy is defined as the proportion of patients in whom a definitive diagnosis can be obtained within a predetermined number of FNA passes.
Procedure: Histological Samples
The proportion of patients (%) in whom a histological tissue can be obtained when performing a biopsy of the pancreas using a specific needle will be assessed.
Active Comparator: 25G FNA needle
Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 25G FNA needle when performing pancreatic biopsy.
 Procedure: Pancreatic Biopsy
A FNA needle will be used to biopsy the pancreatic mass. The rates of diagnostic accuracy (%) will be assessed. Diagnostic accuracy is defined as the proportion of patients in whom a definitive diagnosis can be obtained within a predetermined number of FNA passes.
Procedure: Histological Samples
The proportion of patients (%) in whom a histological tissue can be obtained when performing a biopsy of the pancreas using a specific needle will be assessed.

Detailed Description:

The study compares the median number of passes to establish a definitive diagnosis using the 19G or 25G needles. Also, the ability of both needles to procure a histological core tissue is assessed.

  Eligibility

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

INCLUSION CRITERIA:

(1) Patients with solid pancreatic mass lesions.

EXCLUSION CRITERIA:

  1. Age < 19 years
  2. Unable to safely undergo EUS for any reason
  3. Coagulopathy (INR > 1.6, Prothrombin Time > 18secs, Thrombocytopenia < 80,000 cells/ml)
  4. Unable to consent
  5. Non-English speaking patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01677312

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Florida
Florida Hospital
Orlando, Florida, United States, 32814
Sponsors and Collaborators
Florida Hospital
University of Alabama at Birmingham
Investigators
Principal Investigator: shyam varadarajulu, MD Florida Hospital Center for Interventional Endoscopy
  More Information

No publications provided

Responsible Party: Florida Hospital
ClinicalTrials.gov Identifier: NCT01677312     History of Changes
Other Study ID Numbers: 356077
Study First Received: August 28, 2012
Last Updated: March 12, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 21, 2013