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2016-08
2016-10
2017-10
0
NCT02534246
Milton S. Hershey Medical Center
Milton S. Hershey Medical Center
INTERVENTIONAL
Head to Head Comparison of Two Needles EUS Guided FNB
The aim of this study is to evaluate and compare the diagnostic accuracy and specimen adequacy of two ultrasound biopsy needles. These are two existing FDA approved tissue biopsy regimens, with respect to diagnosis of solid pancreatic lesions.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2015-08-13 | N/A | 2016-09-12 |
2015-08-26 | N/A | 2016-09-13 |
2015-08-27 | N/A | 2016-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Randomized
Interventional Model:
Crossover
Masking:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| 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
|
| 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 |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Direct Comparison of pancreatic mass histologic tissue adequacy using two EUS guided fine needle biopsy needles | Head to head comparison of tissue adequacy for solid pancreatic lesions using two 25 gauge EUS guided fine needle biopsy platforms - ProCore vs SharkCore. | 1year |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
