22G FNA Needle vs. 22G ProCore Needle
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01394159|
Recruitment Status : Completed
First Posted : July 14, 2011
Results First Posted : April 1, 2015
Last Update Posted : March 9, 2018
|Condition or disease||Intervention/treatment|
|Pancreatic Neoplasm||Procedure: 22G ProCore biopsy needle Procedure: 22G standard FNA needle|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Trial Comparing the 22-gauge Aspiration and 22-gauge Biopsy Needles for EUS-guided Sampling of Solid Pancreatic Mass Lesions|
|Study Start Date :||July 2011|
|Primary Completion Date :||September 2011|
|Study Completion Date :||December 2011|
Active Comparator: 22G ProCore biopsy needle
Using the 22G ProCore needle for sampling pancreatic mass lesions, the tissue obtained will be compared to the standard FNA needle.
Procedure: 22G ProCore biopsy needle
Tissue will be acquired with the 22G Procore biopsy needle and the sample will be compared to the sample obtained with the 22G standard FNA needle.
Other Name: Biopsy
Active Comparator: 22G standard FNA needle
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.
Procedure: 22G standard FNA needle
Tissue will be acquired with the 22G standard FNA biopsy needle and the sample will be compared to the sample obtained with the 22G ProCore biopsy needle.
Other Name: biopsy
- Compare the Median Number of Passes Required to Establish a Diagnosis [ Time Frame: 6 months ]
- Diagnosis Achieved With the Needle [ Time Frame: 6 months ]
- Technical Failure [ Time Frame: 6 months ]Malfunction of the needle during endoscopic ultrasound-guided sampling of the pancreatic mass lesion before a diagnosis is achieved
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01394159
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||Shyam Varadarajulu, MD||University of Alabama at Birmingham|