Comparison of a Novel 22-gauge Core Biopsy Needle

M.D. Anderson Cancer Center

Status: Completed

Conditions: Solid Pancreatic Mass Lesions; Malignant Neoplasm of Pancreas

Treatments: Device: Novel 22-gauge Core Biopsy Needle + Standard Biopsy Needle

Study type: Interventional

Funder types: Other

Identifiers

NCT01598194

2011-0907

Details and patient eligibility

About

The goal of this clinical research study is to compare the performance of a newly available needle with reverse bevel design (called the EchoTip® Procore™ needle) with standard needles to see which needle gives better diagnostic information for pancreatic lesions.

Full description

An endoscopic ultrasound-guided needle biopsy or FNA is a special endoscopic procedure used to sample lesions within or next to the digestive tract, including the pancreas. The needle is used to collect material for diagnosis. A special lighted, flexible tube called an endoscope is inserted through the mouth, into the stomach and small intestine. The endoscope also has an ultrasound probe at its tip which can be used to see the pancreas, which is located behind the stomach. The doctor will then use the ultrasound to guide the needle biopsy or FNA.

In this procedure, an average of 4 needle passes (needle sticks) is needed to collect enough tissue for diagnosis. However, the number of passes can be higher or lower, depending on the individual lesion and success of the needle passes.

If participant agrees to take part in this study, 2 different needles (the standard straight hollow-core needle and the new EchoTip® Procore™ needle) will be used to sample the pancreas lesion. Two (2) passes will be performed with each needle type and compared. If additional passes are needed for diagnosis, they will not be included in this study. After the first set of needle passes, the doctor may decide that more passes are needed.

Final test results will be taken from the diagnostic results from each needle pass. The results from both types of the needle will be included in the participant's medical record.

This is an investigational study. All needles used in this study are FDA approved and commercially available. Comparing the needles is investigational.

Up to 60 participants will take part in this study. All will be enrolled at MD Anderson.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient age 18 years and older.
2. All patients referred for EUS FNA of endoscopically accessible solid pancreatic lesions.

Exclusion criteria

1. Unable to obtain informed consent.
2. Unable to tolerate the procedure.
3. Women with known pregnancy at time.
4. Patient age less than 18 years of age.
5. Bleeding diathesis
6. Cystic pancreatic lesions
7. Lesion not accessible by EUS guided FNA

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Novel 22-gauge Core Biopsy Needle Standard Biopsy Needle

Experimental group

Description:

The 22-gauge core biopsy needle with reverse bevel design (EchoTip® Procore™) will be compared prospectively to the standard straight hollow-core 22-gauge or 25-gauge FNA needle already used in our clinical practice for the diagnosis of solid pancreatic lesions.

Treatment:

Device: Novel 22-gauge Core Biopsy Needle + Standard Biopsy Needle