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OpenTrials
Completed

NCT Number: NCT01501903

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

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.

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Key information

Age range

19 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAB

Birmingham, Alabama, 35294, United States

About this study

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

Standard technique: FNA performed in unidirectional fashion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 19 years
  • Solid Pancreatic Mass Lesions

Exclusion criteria

  • Age < 19 years
  • Coagulopathy
  • Unable to consent

Treatment and study plan

standard

Procedure

FNA in a single plane

Other names: Standard Versus Fanning Techniques for EUS-FNA

Fanning

Procedure

FNA in multiple planes

Other names: Standard Versus Fanning Techniques for EUS-FNA

Primary outcomes

  1. Diagnostic accuracy

    Time frame: 2 months

    The number of pancreatic masses that are correctly diagnosed with each needle type

Secondary outcomes

  1. Number of passes for diagnosis

    Time frame: 2 months

    Number of passes required to acquire tissue diagnosis using each needle type

Sponsors and collaborators

Lead sponsor

Shyam Varadarajulu

Other

Registry information

Official study title

Randomized Trial Comparing the Standard and Fanning Techniques for Fine Needle Aspiration of Pancreatic Mass Lesions at Endoscopic Ultrasound

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 30, 2011
Registry last updated
Feb 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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