Standard Versus Fanning Techniques for Endoscopic Ultrasound-Fine Needle Aspiration (EUS-FNA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shyam Varadarajulu, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01501903
First received: October 18, 2011
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

Endoscopic Ultrasound (EUS)-guided biopsy is the most ideal technique for evaluating a growth in the pancreas. EUS-guided biopsies yield a definitive diagnosis in greater than 80% of cases. In 15-20% of the cases, a definitive diagnosis cannot be made despite multiple attempts. One of the reasons why a diagnosis cannot be made is due to the focal location of the cancer; i.e., the cancer can be situated in a corner of a big mass and the needle fails to sample the cancer cells. The fanning technique is a method where the needle moves in multiple directions within a mass and therefore there is a better chance of the cancer cells being sampled compared to the standard technique where the needle moves in only one direction. The diagnostic performance of both these techniques has not been compared in a randomized fashion.


Condition Intervention
Pancreatic Tumors
Procedure: Standard
Procedure: Fanning

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Randomized Trial Comparing the Standard and Fanning Techniques for Fine Needle Aspiration of Pancreatic Mass Lesions at Endoscopic Ultrasound

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Diagnostic accuracy [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    The number of pancreatic masses that are correctly diagnosed with each needle type


Secondary Outcome Measures:
  • Number of passes for diagnosis [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Number of passes required to acquire tissue diagnosis using each needle type


Enrollment: 52
Study Start Date: September 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard
Biopsy using standard technique of FNA
Procedure: Standard
FNA in a single plane
Other Name: Standard Versus Fanning Techniques for EUS-FNA
Fanning
Biopsy using fanning technique
Procedure: Fanning
FNA in multiple planes
Other Name: Standard Versus Fanning Techniques for EUS-FNA

Detailed Description:

Fanning technique: Fine Needle Aspiration (FNA) performed in multiple directions within a mass.

Standard technique: FNA performed in unidirectional fashion.

  Eligibility

Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 19 years
  • Solid Pancreatic Mass Lesions

Exclusion Criteria:

  • Age < 19 years
  • Coagulopathy
  • Unable to consent
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01501903

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

No publications provided by University of Alabama at Birmingham

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shyam Varadarajulu, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01501903     History of Changes
Other Study ID Numbers: F110907002
Study First Received: October 18, 2011
Last Updated: February 1, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 22, 2014