NCT01598194

Comparison of a Novel 22-gauge Core Biopsy Needle

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Solid Pancreatic Mass Lesions
• Malignant Neoplasm of Pancreas

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2012-01-30
• Primary completion: 2017-07-06
• Completion: 2017-07-06
• First posted: 2012-05-15
• Last updated: 2018-12-27
• Results posted: 2018-12-27

Locations

1 site across 1 country: United States