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Prospective Comparison of a Novel 22-gauge Core Biopsy Needle With Reverse Bevel Design to a Standard Endoscopic Ultrasound (EUS) Guided Fine Needle Aspiration (FNA) Needle for Diagnosis of Solid Pancreatic Mass Lesions


N/A
18 Years
N/A
Open (Enrolling)
Both
Solid Pancreatic Mass Lesions

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Trial Information

Prospective Comparison of a Novel 22-gauge Core Biopsy Needle With Reverse Bevel Design to a Standard Endoscopic Ultrasound (EUS) Guided Fine Needle Aspiration (FNA) Needle for Diagnosis of Solid Pancreatic Mass Lesions


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 a 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 clinic, an average of 4 needle passes (needle sticks) are 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 you agree 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 needle will be included in your 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 patients will take part in this study. All will be enrolled at MD Anderson.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Comparison Novel 22-gauge Core Biopsy Needle to Standard

Outcome Description:

Assess if 22-gauge EchoTip® Procore™ needle has a better diagnostic performance compared to standard 22-gaugeG and 25-gaugeG straight hollow core needles The primary endpoint is whether or not the needle pass result provides diagnostic material (yes vs. no). For each patient, both needles will be used to sample the same lesion. Two needle passes will be performed with each needle type.

Outcome Time Frame:

1 Day

Safety Issue:

No

Principal Investigator

Brian Weston, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2011-0907

NCT ID:

NCT01598194

Start Date:

January 2012

Completion Date:

Related Keywords:

  • Solid Pancreatic Mass Lesions
  • solid pancreatic mass lesions
  • 22-gauge core biopsy needle
  • reverse bevel design
  • endoscopic ultrasound
  • EUS
  • guided
  • fine needle aspiration
  • FNA

Name

Location
UT MD Anderson Cancer Center Houston, Texas  77030