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Completed

NCT Number: NCT01677312

Trial Comparing 19 and 25-gauge EUS-FNA Needles

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

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Key information

Conditions

Cancer of Pancreas Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasm Pancreatic Neoplasms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

(1) Patients with solid pancreatic mass lesions.

Exclusion criteria

  • Age < 19 years
  • Unable to safely undergo EUS for any reason
  • Coagulopathy (INR > 1.6, Prothrombin Time > 18secs, Thrombocytopenia < 80,000 cells/ml)
  • Unable to consent
  • Non-English speaking patients

Treatment and study plan

Pancreatic Biopsy

Procedure

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.

Histological Samples

Procedure

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.

Primary outcomes

  1. Median Number of Passes to Establish Diagnosis

    Time frame: 5 months

    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 outcomes

  1. Procurement of Histological Samples

    Time frame: 30 days

    The ability of the 19G and 25G needles to obtain core (histological) tissue will be compared and a significance will be determined.

  2. Needle Dysfunction

    Time frame: 2 hours

    The percentage 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.

  3. Complications

    Time frame: 30 days

    The safety profile of the 19 and 25G needles will be compared that includes bleeding, pancreatitis and perforation.

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Collaborators

  • University of Alabama at Birmingham

Registry information

Official study 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

Acronym: EUS-FNA

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 3, 2012
Registry last updated
Mar 17, 2020

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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