Comparison of Two Fine Needle Biopsy Needles for Solid Pancreatic Masses (Expect)

AdventHealth

Status: Completed

Conditions: Pancreatic Neoplasm

Treatments: Device: Acquire EUS Biopsy Device; Device: SharkCore Biopsy System

Study type: Interventional

Funder types: Other

Identifiers

NCT02910960

886967

Details and patient eligibility

About

This is a randomized prospective clinical study comparing the Acquire Biopsy Device to SharkCore Biopsy Device.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Acquire EUS Biopsy Device

Active Comparator group

Description:

All patients will undergo sampling of pancreatic masses using the Acquire EUS Biopsy Device. Both needles will be used, but the needle to be used first will be based on randomization. A minimum of at least one pass and a maximum of 8 passes will be performed using both needle types.

Treatment:

Device: Acquire EUS Biopsy Device

SharkCore Biopsy System

Active Comparator group

Description:

All patients will undergo sampling of pancreatic masses using the SharkCore Biopsy System. Both needles will be used, but the needle to be used first will be based on randomization. A minimum of at least one pass and a maximum of 8 passes will be performed using both needle types.

Treatment:

Device: SharkCore Biopsy System