Comparison Of Two Fine Needle Biopsy Needles For Solid Pancreatic Masses

Study Overview

Comparison of Two Fine Needle Biopsy Needles for Solid Pancreatic Masses

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.

Pancreatic Neoplasm

DEVICE: Acquire EUS Biopsy Device
DEVICE: SharkCore Biopsy System

886967

Study Record Dates

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
First Submitted 2016-08-22	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-02-12
First Submitted that Met QC Criteria 2016-09-20	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-02-15
First Posted (ACTUAL) 2016-09-22	Results First Posted N/A	Last Verified 2019-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Single

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: 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 perfor	DEVICE: Acquire EUS Biopsy Device 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.
ACTIVE_COMPARATOR: SharkCore Biopsy System 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 performe	DEVICE: SharkCore 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.

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: 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 perfor

DEVICE: Acquire EUS Biopsy Device

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.

ACTIVE_COMPARATOR: SharkCore Biopsy System

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 performe

DEVICE: SharkCore 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.

Primary Outcome Measures	Measure Description	Time Frame
Total area of procured tissue between the two FNB needles	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.	48 hours

Secondary Outcome Measures	Measure Description	Time Frame
Diagnostic adequacy between the two FNB needles	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.	48 hours

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

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:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Shyam Varadarajulu, MD, AdventHealth

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Hewitt MJ, McPhail MJ, Possamai L, Dhar A, Vlavianos P, Monahan KJ. EUS-guided FNA for diagnosis of solid pancreatic neoplasms: a meta-analysis. Gastrointest Endosc. 2012 Feb;75(2):319-31. doi: 10.1016/j.gie.2011.08.049.
Varadarajulu S, Fraig M, Schmulewitz N, Roberts S, Wildi S, Hawes RH, Hoffman BJ, Wallace MB. Comparison of EUS-guided 19-gauge Trucut needle biopsy with EUS-guided fine-needle aspiration. Endoscopy. 2004 May;36(5):397-401. doi: 10.1055/s-2004-814316.
Bang JY, Hawes R, Varadarajulu S. A meta-analysis comparing ProCore and standard fine-needle aspiration needles for endoscopic ultrasound-guided tissue acquisition. Endoscopy. 2016 Apr;48(4):339-49. doi: 10.1055/s-0034-1393354. Epub 2015 Nov 12.
Ngamruengphong S, Li F, Zhou Y, Chak A, Cooper GS, Das A. EUS and survival in patients with pancreatic cancer: a population-based study. Gastrointest Endosc. 2010 Jul;72(1):78-83, 83.e1-2. doi: 10.1016/j.gie.2010.01.072.
Othman MO, Wallace MB. The role of endoscopic ultrasonography in the diagnosis and management of pancreatic cancer. Gastroenterol Clin North Am. 2012 Mar;41(1):179-88. doi: 10.1016/j.gtc.2011.12.014. Epub 2012 Jan 16.
Bang JY, Hebert-Magee S, Navaneethan U, Hasan MK, Hawes R, Varadarajulu S. Randomized trial comparing the Franseen and Fork-tip needles for EUS-guided fine-needle biopsy sampling of solid pancreatic mass lesions. Gastrointest Endosc. 2018 Jun;87(6):1432-1438. doi: 10.1016/j.gie.2017.11.036. Epub 2018 Jan 3.

Learn

Resources

Patients

Caregivers

Clinical Trial Record