22G FNA Needle vs. 22G ProCore Needle

Pancreatic Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01394159
• Other study ID #: F110506010
• Status: Completed
• Phase: N/A
• First received: July 12, 2011
• Last updated: February 9, 2018
• Start date: July 2011
• Est. completion date: December 2011

Study information

• Verified date: February 2018
• Source: Florida Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

-All patients with solid pancreatic mass lesions

Exclusion Criteria:

• Coaguloapthy,

• minors,

• prgenant patients

Related Conditions & MeSH terms

• Pancreatic Neoplasm
• Pancreatic Neoplasms

Intervention

Procedure:
• 22G ProCore biopsy needle
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.
• 22G standard FNA needle
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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Florida Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the Median Number of Passes Required to Establish a Diagnosis		6 months
Secondary	Diagnosis Achieved With the Needle		6 months
Secondary	Technical Failure	Malfunction of the needle during endoscopic ultrasound-guided sampling of the pancreatic mass lesion before a diagnosis is achieved	6 months