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OpenTrials
Completed

NCT Number: NCT01394159

22G FNA Needle vs. 22G ProCore Needle

The aim of this research study is to identify the best needle for performing biopsy during EUS procedures. There are two types of needles for performing biopsy: A FNA needle that provides a small sample of tissue for analysis and a 22G ProCore needle that provides larger amount of tissue. It is not clear at this point which of the two needles is superior for performing biopsy. This study will attempt to identify the better needle by assessing the performance of both needles in a randomized fashion.

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Key information

Conditions

Pancreatic Neoplasm Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases 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, 35294, United States

About this study

In this randomized trial, the 22G standard fine needle aspiration needle was compared with the newly developed 22G ProCore needle for sampling pancreatic mass lesions during endoscopic ultrasound. Patients were randomized into the two needle groups and then various outcomes were compared between the two needle types, including the number of passes needed to establish a diagnosis, the ability to procure enough tissue sample to be able to make a diagnosis, the rates of needle failure and complication rates.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

-All patients with solid pancreatic mass lesions

Exclusion criteria

  • Coaguloapthy,
  • minors,
  • prgenant patients

Treatment and study plan

22G ProCore biopsy needle

Procedure

Tissue will be acquired with the 22G Procore biopsy needle and the sample will be compared to the sample obtained with the 22G standard FNA needle.

Other names: Biopsy

22G standard FNA needle

Procedure

Tissue will be acquired with the 22G standard FNA biopsy needle and the sample will be compared to the sample obtained with the 22G ProCore biopsy needle.

Other names: biopsy

Primary outcomes

  1. Compare the Median Number of Passes Required to Establish a Diagnosis

    Time frame: 6 months

Secondary outcomes

  1. Diagnosis Achieved With the Needle

    Time frame: 6 months

  2. Technical Failure

    Time frame: 6 months

    Malfunction of the needle during endoscopic ultrasound-guided sampling of the pancreatic mass lesion before a diagnosis is achieved

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Registry information

Official study title

Randomized Trial Comparing the 22-gauge Aspiration and 22-gauge Biopsy Needles for EUS-guided Sampling of Solid Pancreatic Mass Lesions

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 14, 2011
Registry last updated
Mar 9, 2018

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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