Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

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.

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.

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.

Acquire EUS Biopsy Device

SharkCore Biopsy System

Shyam Varadarajulu, MD

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

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.

Comparison of Two Fine Needle Biopsy Needles for Solid Pancreatic Masses

Randomized Trial Comparing Two Fine Needle Biopsy Needles for Endoscopic Ultrasound-guided Sampling of Solid Pancreatic Masses.

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.

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.

AdventHealth

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

1. At EUS, once the pancreatic mass is identified, patients will be randomized to undergo sampling using the 22G Acquire EUS Biopsy Device or Expect EUS Aspiration Needle.

Expect EUS Aspiration Needle

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

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.

Comparing Biopsy Needles for Endoscopic Ultrasound Guided Samples for Pancreatic Masses

Randomized Trial Comparing Fine Needle Biopsy and Fine Needle Aspiration Needles for Endoscopic Ultrasound -Guided Sampling of Solid Pancreatic Masses

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Comparison of Two Fine Needle Biopsy Needles for Solid Pancreatic Masses	NCT02910960	Pancreatic Neop...	Acquire EUS Bio... SharkCore Biops...	18 Years -	AdventHealth
Comparing Biopsy Needles for Endoscopic Ultrasound Guided Samples for Pancreatic Masses	NCT02911974	Pancreatic Neop...	Acquire EUS Bio... Expect EUS Aspi...	18 Years -	AdventHealth

Spots Global Cancer Trial Database for acquire eus biopsy device