22G FNA Needle vs. 22G ProCore Needle

AdventHealth

Status: Completed

Conditions: Pancreatic Neoplasm

Treatments: Procedure: 22G ProCore biopsy needle; Procedure: 22G standard FNA needle

Study type: Interventional

Funder types: Other

Identifiers

NCT01394159

F110506010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-All patients with solid pancreatic mass lesions

Exclusion criteria

• Coaguloapthy,
• minors,
• prgenant patients

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

22G ProCore biopsy needle

Active Comparator group

Description:

Using the 22G ProCore needle for sampling pancreatic mass lesions, the tissue obtained will be compared to the standard FNA needle.

Treatment:

Procedure: 22G ProCore biopsy needle

22G standard FNA needle

Active Comparator group

Description:

Using the 22G standard fine needle aspiration needle (FNA) for sampling pancreatic mass lesions, the tissue obtained will be compared to the 22 G ProCore needle.

Treatment:

Procedure: 22G standard FNA needle