AzTrials
AzTrials

Pancreatic NeoplasmExpectNCT02910960

Comparison of Two Fine Needle Biopsy Needles for Solid Pancreatic Masses

A study testing Acquire EUS Biopsy Device and SharkCore Biopsy System in people with Pancreatic Neoplasm, run by AdventHealth at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a randomized prospective clinical study comparing the Acquire Biopsy Device to SharkCore Biopsy Device. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Neoplasm
What is being tested?
Acquire EUS Biopsy Device and SharkCore Biopsy System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
Dec 2016to Oct 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Center for Interventional Endoscopy - Florida Hospital

    Orlando, Florida, 32803

Other trials in United States

About this study

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

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

Read the detailed 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.

Being tested
Acquire EUS Biopsy Device, SharkCore Biopsy System
Keywords
fine needle biopsy, EUS, solid pancreatic mass
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acquire EUS Biopsy DeviceDevice

    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.

  • SharkCore Biopsy SystemDevice

    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.

Study groups in NCT02910960
Study groupRoleWhat they receive
Acquire EUS Biopsy DeviceActive comparatorAll 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.
Receives: Device: Acquire EUS Biopsy Device
SharkCore Biopsy SystemActive comparatorAll 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.
Receives: Device: SharkCore Biopsy System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 48 hours

Secondary outcomes (1)

  1. 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.

    Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2016 (estimated)
  2. Study startDec 2016
  3. Primary completion28 Jul 2018
  4. Study completionOct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02910960
Sponsor's protocol ID
886967
Acronym
Expect
Status last verified
Feb 2019
First submitted
22 Aug 2016
Last updated
15 Feb 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

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.

    PubMed 22248600

  • 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.

    PubMed 15100946

  • 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.

    PubMed 26561917

  • 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.

    PubMed 20620274

  • 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.

    PubMed 22341257

  • 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.

    PubMed 29305893

Questions about this trial

What is this clinical trial studying?

A study testing Acquire EUS Biopsy Device and SharkCore Biopsy System in people with Pancreatic Neoplasm, run by AdventHealth at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total area of procured tissue between the two FNB needles (time frame: 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02910960, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in