Head to Head Comparison of Two Needles EUS Guided FNB
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|ClinicalTrials.gov Identifier: NCT02534246|
Recruitment Status : Withdrawn
First Posted : August 27, 2015
Last Update Posted : September 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Tumor||Device: Ultrasound biopsy needle Echo Tip ProCore Device: Ultrasound biopsy needle SharkCore||Not Applicable|
EUS guided core biopsy using various needle designs and sizes, seems to be a promising technique to procure tissue in solid pancreatic masses for making an accurate histological diagnosis. EUS-guided core biopsies of pancreas may aid in patients with non-diagnostic EUS-FNA samples and institutions where they do not have on-site cytopathology available for prompt evaluation of tissue adequacy. Making an accurate diagnosis not only assists in planning appropriate treatment but also may decrease morbidity/mortality from unnecessary surgeries.
Our goal is to evaluate and compare the diagnostic accuracy and specimen adequacy of the Cook Medical 25 gauge ProCore ultrasound biopsy needle and the Medtronic (Beacon) 25 gauge SharkCore ultrasound biopsy needle. We hypothesize the endoscopic ultrasound tissue biopsy will not be different in diagnostic accuracy of solid pancreatic lesions when using a 25 gauge SharkCore ultrasound biopsy needle in comparison with the 25 gauge ProCore ultrasound biopsy needle.
This is a non- inferior paired, prospective, single-blind study design in which patients undergoing EUS for a solid pancreatic mass. Two biopsies with each of the two endoscopic needles of interest in this study will be used in random order. The biopsy needle passed first will be randomized, after which the two needles will be alternated for each of the remaining biopsies. Randomization will occur in permuted blocks of 3. Physician will record the ease/ difficulty of obtaining each of the 4 biopsies on a scale of 1 to 5. Also, they record the needle visibility on ultrasound. The biopsy site will be examined for evidence of bleeding. Biopsies will be sent to the pathology laboratory in a blinded fashion in coded containers, where pathologist determine the number of adequate biopsies out of two passes of each needle.The pathologist will also provide a scale of perceived diagnostic usefulness of material in a blinded fashion. Post procedure care will including a letter to referring physician with recommendations for treatment and follow up.
This study include 30 patients referred to Hershey Medical Center.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||A Paired Prospective, Single Blinded Study of the Diagnostic Accuracy and Specimen Adequacy of Two Endoscopic Tissue Biopsy Needles for Diagnosis Solid Pancreatic Mass|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||October 2016|
|Estimated Study Completion Date :||October 2017|
Experimental: Pro Core EUS guided Fine Needle Biopsy
Echo Tip ProCore ultrasound biopsy needle (Cook Medical 25 gauge) with reverse bevel design for diagnosis of pancreatic lesions.
Device: Ultrasound biopsy needle Echo Tip ProCore
Two passes preformed with Echo Tip ProCore ultrasound biopsy needle (Cook Medical 25 gauge) and two passes will be performed using SharkCore ultrasound biopsy needle (Medtronic [Beacon] 25 gauge) from single lesion.
Experimental: Shark Core EUS guided Fine Needle Biopsy
SharkCore ultrasound biopsy needle (Medtronic [Beacon] 25 gauge) with six cutting edge surfaces and an opposing bevel design for diagnosis of pancreatic lesions.
Device: Ultrasound biopsy needle SharkCore
- Direct Comparison of pancreatic mass histologic tissue adequacy using two EUS guided fine needle biopsy needles [ Time Frame: 1year ]Head to head comparison of tissue adequacy for solid pancreatic lesions using two 25 gauge EUS guided fine needle biopsy platforms - ProCore vs SharkCore.
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): NCT02534246
|United States, Pennsylvania|
|Penn State Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||John M Levenick, MD||Milton S. Hershey Medical Center|