Comparison of Two Fine Needle Biopsy Needles for Solid Pancreatic Masses (Expect)

February 12, 2019 updated by: AdventHealth

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32803
        • Center for Interventional Endoscopy - Florida Hospital

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.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • 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.
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 performed using both needle types.
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.

What is the study measuring?

Primary Outcome Measures

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

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

Outcome Measure
Measure Description
Time Frame
Diagnostic adequacy between the two FNB needles
Time Frame: 48 hours

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

Collaborators and Investigators

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

Sponsor

AdventHealth

Publications and helpful links

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

General Publications

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 Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

July 28, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

August 22, 2016

First Submitted That Met QC Criteria

September 20, 2016

First Posted (Estimate)

September 22, 2016

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 12, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 886967

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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