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

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ClinicalTrials.gov Identifier: NCT01501903
Recruitment Status : Completed
First Posted : December 30, 2011
Last Update Posted : February 2, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Pancreatic Tumors Procedure: Standard Procedure: Fanning

Detailed Description:

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

Standard technique: FNA performed in unidirectional fashion.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2011
Primary Completion Date : November 2011
Study Completion Date : November 2011
Arms and Interventions

Arm Intervention/treatment
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
Biopsy using fanning technique
Procedure: Fanning
FNA in multiple planes
Other Name: Standard Versus Fanning Techniques for EUS-FNA

Outcome Measures

Primary Outcome Measures :
  1. Diagnostic accuracy [ Time Frame: 2 months ]
    The number of pancreatic masses that are correctly diagnosed with each needle type

Secondary Outcome Measures :
  1. Number of passes for diagnosis [ Time Frame: 2 months ]
    Number of passes required to acquire tissue diagnosis using each needle type

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > 19 years
  • Solid Pancreatic Mass Lesions

Exclusion Criteria:

  • Age < 19 years
  • Coagulopathy
  • Unable to consent
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): NCT01501903

United States, Alabama
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, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01501903     History of Changes
Other Study ID Numbers: F110907002
First Posted: December 30, 2011    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: February 2012

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