Comparing Biopsy Needles for Endoscopic Ultrasound Guided Samples for Pancreatic Masses (Expect)
Randomized Trial Comparing Fine Needle Biopsy and Fine Needle Aspiration Needles for Endoscopic Ultrasound -Guided Sampling of Solid Pancreatic Masses
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
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Orlando, Florida, United States, 32803
- Center for Interventional Endoscopy - Florida Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
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 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.
|
|
Active Comparator: 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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The total area of procured tissue between the FNA and FNB needles
Time Frame: 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. |
6 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnostic adequacy between the FNA and FNB needles
Time Frame: 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. |
6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 889569
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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