Pancreatic Neoplasm
Conditions
Keywords
fine needle biopsy, EUS, solid pancreatic mass
Brief summary
This is a randomized prospective clinical study comparing the Acquire Biopsy Device to SharkCore Biopsy Device.
Detailed description
At EUS, once the pancreatic mass is identified, patients will be randomized to undergo sampling using one of the two FNB needle. All patients will undergo sampling of pancreatic masses using both needles but the needle to be used first will be based on randomization. Subsequent passes will be performed by alternate needles and once onsite diagnosis is established using either needle type, more passes will not be performed for onsite diagnostic adequacy. However, a minimum of at least one pass and a maximum of 8 passes will be performed using both needle types. The number of passes needed to achieve diagnostic adequacy using both needles will documented. Four dedicated passes will then be performed using the initial randomization sequence for cell block. Two passes will be performed using each needle type and the specimen will be preserved in formalin and sent for cell block processing. If the doctor cannot obtain enough tissue with the study needles, another needle with a different gauge (19 or 25) will be used. This will also be a maximum of 8 passes. Information about the number of needles used, how many passes were performed, any problems with the needles will be collected. If there is not enough tissue available from these passes to establish a diagnosis, the subject will be asked to come back at another time for a repeat procedure.
Interventions
At EUS, once the pancreatic mass is identified, patients will be randomized to undergo sampling using the 22G Acquire EUS Biopsy Device or SharkCore Biopsy System.
DEVICESharkCore Biopsy System
At EUS, once the pancreatic mass is identified, patients will be randomized to undergo sampling using the 22G Acquire EUS Biopsy Device or SharkCore Biopsy System.
Sponsors
AdventHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled to undergo EUS * Patients with solid pancreatic masses on cross-sectional imaging or with jaundice secondary to biliary obstruction * Able and willing to provide written or verbal consent
Exclusion criteria
* Unable to safely undergo EUS for any reason * Coagulopathy (Prothrombin time \> 18 secs, platelet count \< 80,000/ml) * Active alcohol or other drug use or significant psychiatric illness * Pregnancy * Unable or unwilling to provide consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total area of procured tissue between the two FNB needles | 48 hours | The primary objective of this study is to compare the total area of procured tissue between the two FNB needles in patients undergoing EUS-guided sampling of pancreatic masses. Pancreatic masses sampled using the Acquire Endoscopic Ultrasound Fine Needle Biopsy Device needle should yield a tissue volume greater than the SharkCore Fine Needle Biopsy System needle because the serrated design of the FNB needle tip is expected to procure greater volume of tissue. This will be measured using a specialized digital image analysis software. This hypothesis will be tested by comparing the total tissue volume, tumor volume within the tissue, stroma volume within the tissue, tumor vs. stroma ratio and the macroscopic length of the procured tissue measured in millimeters. When evaluated together, the above measurement provide the total area of tissue procured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic adequacy between the two FNB needles | 48 hours | The secondary objective of this study is to compare the diagnostic adequacy between the two FNB needles in patients undergoing EUS-guided sampling of pancreatic masses. Pancreatic masses sampled using the Acquire Endoscopic Ultrasound Fine Needle Biopsy Device needle should yield diagnostic adequacy with fewer passes as they are expected to procure a greater area tissue than the SharkCore Fine Needle Biopsy System needle. This hypothesis will be tested by comparing the number of passes required to establish a onsite diagnosis using both needle types in individual patients. |
Countries
United States
Outcome results
None listed