Comparing Biopsy Needles for Endoscopic Ultrasound Guided Samples for Pancreatic Masses

Not Applicable

Completed

• Conditions: Pancreatic Neoplasm
• Interventions: Device: Acquire EUS Biopsy Device; Device: Expect EUS Aspiration Needle

• Registration Number: NCT02911974
• Lead Sponsor: AdventHealth

Brief Summary

This is a randomized prospective clinical study comparing a fine needle biopsy device and an aspiration needle.

Detailed Description

At EUS, once the pancreatic mass is identified, patients will be randomized to undergo sampling using the 22G FNA or 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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-22
• Study First Submitted QC: 2016-09-20
• Study First Posted: 2016-09-23
• Primary Completion: 2017-07
• Study Completion: 2018-08
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-12
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acquire EUS Biopsy Device	Acquire EUS Biopsy Device	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.
Expect EUS Aspiration Needle	Expect EUS Aspiration Needle	All patients will undergo sampling of pancreatic masses using the Expect EUS Aspiration Needle. 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

Primary Outcome Measures

Name	Time	Method
The total area of procured tissue between the FNA and FNB needles	6 months.	The primary objective of this study is to compare the total area of procured tissue between the FNA and FNB needles in patients undergoing EUS-guided sampling of pancreatic masses.; Pancreatic masses sampled using the FNB needle should have a tissue area greater than the FNA needle because of the serrated design of the FNB needle tip. This will be measured using a specialized digital image analysis software.; This hypothesis will be tested by comparing the total tissue area, tumor area within the tissue, stroma area within the tissue, tumor vs. stroma ratio and the macroscopic length of the procured tissue measured in millimeters. The total of these measurements will provide information about the area of procured tissue.

Secondary Outcome Measures

Name	Time	Method
Diagnostic adequacy between the FNA and FNB needles	6 months	The secondary objective of this study is to compare the diagnostic adequacy between the FNA and FNB needles in patients undergoing EUS-guided sampling of pancreatic masses.; Pancreatic masses sampled using the FNB needle should yield diagnostic adequacy with fewer passes as they are expected to procure a greater area tissue than the FNA 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.

Trial Locations

Locations (1)

Center for Interventional Endoscopy - Florida Hospital; 🇺🇸 Orlando, Florida, United States