This trial is active, not recruiting.

Conditions solid pancreatic mass lesions, malignant neoplasm of pancreas
Treatment novel 22-gauge core biopsy needle + standard biopsy needle
Sponsor M.D. Anderson Cancer Center
Start date January 2012
End date January 2017
Trial size 60 participants
Trial identifier NCT01598194, 2011-0907


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
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.
novel 22-gauge core biopsy needle + standard biopsy needle
Two passes performed with the standard 22-gauge or 25-gauge straight hollow core needle and two passes will be performed using the 22-gauge EchoTip® Procore™ needle. All passes will be taken from a single lesion and from the same endoscopic location.

Primary Outcomes

Comparison Novel 22-gauge Core Biopsy Needle to Standard
time frame: 1 Day

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
Principal investigator Brian Weston, MD
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 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.