Fine Needle Biopsy of Solid Pancreatic Mass Lesions

August 3, 2020 updated by: AdventHealth

Randomized Trial Comparing Fine Needle Biopsy Needles and Different Techniques for Endoscopic-guided Fine Needle Biopsy of Solid Pancreatic Mass Lesions

This is a randomized trial to evaluate and directly compare the tissue quality, diagnostic sucess and safety profile of four different Fine Needle Biopsy needles.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is currently the standard method for sampling solid pancreatic masses, with reported sensitivity for malignant cytology of 85-95%, specificity of 95-98% and diagnostic accuracy of 78-95%. Diagnostic failure of EUS-FNA can be due to inadequate targeting, inexperience of the endoscopist/pathologist, or necrotic or fibrotic tumors in which viable cells are difficult to obtain. The cellularity and architectural representation of the sample can also be determined by the needle used and its specific features. Recently, new needles known as "fine needle biopsy (FNB)" needles have become available that are specially designed to promote the collection of core tissue by unique designs of their needle tips. The advantages of FNB over FNA needles are that (a) the quality of tissue procured is superior: FNA needles yield cytology whereas FNB needles yield histology (b) molecular marker analysis can be performed more reliably on histology samples than cytology aspirates and (c) as histological tissue is greater in quantity than cytological aspirates, a quicker diagnosis with fewer passes can be established by histology than cytology.

Four different types of FNB needles are currently available - reverse-bevel tip (EchoTip ProCore HD Ultrasound Biopsy Needle, Cook Medical, Bloomington, IN), Menghini-tip (EZ shot, Olympus America, Center Valley, PA), Franseen tip (Acquire, Boston Scientific Corporation, Natick, MA) and fork-tip (SharkCore, Medtronic Corporation/Covidien, Newton, MA) needles, each with unique tip designs to facilitate procurement of histological core tissue. Although we have previously compared in randomized trials the diagnostic yield of Franseen and fork-tip FNB needles and have shown the two needles to be equivalent, there are currently no randomized trials directly comparing all four FNB needle types. EUS-guided tissue acquisition can also be performed using different techniques, including the use of suction, no use of suction and the stylet retraction technique. There are currently no studies comparing these different tissue acquisition techniques using the different FNB needles and no study has demonstrated the best technique for FNB.

Study Type

Interventional

Enrollment (Anticipated)

130

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
        • Recruiting
        • AdventHealth Orlando

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. All patients referred for EUS-guided tissue acquisition of suspected or confirmed solid pancreatic mass lesions visualized on any radiological imaging
  2. Able and willing to provide written or verbal consent
  3. ≥ 18 years old
  4. Able to undergo conscious sedation for EUS procedure

Exclusion Criteria:

  1. <18 years old
  2. Unable to obtain informed consent from the patient
  3. Medically unfit for sedation
  4. Pregnant patients
  5. No pancreatic mass lesions visualized on EUS
  6. Irreversible coagulopathy as determined by platelet count < 50,000/microL or International Normalized Ratio (INR) > 1.5
  7. Unable to stop anti-platelet agents prior to the procedure

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: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 22 Gauge FNB Needle - ProCore
The 22 Gauge FNB Needle - ProCore will be used to biopsy solid pancreatic mass lesions.
Diagnostic test: Solid pancreatic mass lesion biopsy
The needle will be used to puncture the lesion and remove a piece of tissue from the mass for histological diagnosis.
Other Names:
  • biopsy, fine needle biopsy, fine needle aspiration
Active Comparator: 22 Gauge FNB Needle - Acquire
The 22 Gauge FNB Needle - Acquire will be used to biopsy solid pancreatic mass lesions.
Diagnostic test: Solid pancreatic mass lesion biopsy
The needle will be used to puncture the lesion and remove a piece of tissue from the mass for histological diagnosis.
Other Names:
  • biopsy, fine needle biopsy, fine needle aspiration
Active Comparator: 22 Gauge FNB Needle - SharkCore
The 22 Gauge FNB Needle - SharkCore will be used to biopsy solid pancreatic mass lesions.
Diagnostic test: Solid pancreatic mass lesion biopsy
The needle will be used to puncture the lesion and remove a piece of tissue from the mass for histological diagnosis.
Other Names:
  • biopsy, fine needle biopsy, fine needle aspiration
Active Comparator: 22 Gauge FNB needle - EZ Shot 3 Plus
The 22 Gauge FNB Needle - EZ Shot 3 Plus will be used to biopsy solid pancreatic mass lesions.
Diagnostic test: Solid pancreatic mass lesion biopsy
The needle will be used to puncture the lesion and remove a piece of tissue from the mass for histological diagnosis.
Other Names:
  • biopsy, fine needle biopsy, fine needle aspiration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of cellularity in biopsy sample
Time Frame: 3 days
Compare the degree of cellularity of the obtained tissue in the biopsy sample between the four FNB needles in patients undergoing EUS-guided sampling of pancreatic masses using the three different sampling techniques. Cellularity is defined as the proportion of core tissue to total specimen area.
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic adequacy of the biopsy sample
Time Frame: 1 day
Documentation of the presence of adequate tissue material (pancreatic parenchyma and tumor if applicable) in the biopsy sample.
1 day
Specimen bloodiness in biopsy sample
Time Frame: 1 day
Measured as the area of bloodiness in the biopsy sample, with calculation as a percentage in the microscopic field.
1 day
Presence of crush artefact in biopsy sample
Time Frame: 1 day
Documenting the presence or absence of crush artefact in the biopsy sample. If present, it is measured as the area of artefact in biopsy sample, with calculation as a percentage in relation to the total sample area.
1 day
Technical failure
Time Frame: 1 day
Measured as the inability to successfully perform the fine needle biopsy using the assigned needle, due to any needle dysfunction.
1 day
Adverse events
Time Frame: 7 days, 30 days, and 6 months
The subject will be asked to report and medical records will be reviewed for any adverse events related to the procedure or the underlying disease.
7 days, 30 days, and 6 months
Diagnostic operating characteristics
Time Frame: 6 months
Compare the diagnostic operating characteristics of the biopsy sample and detection of neoplasia (defined as sensitivity, specificity, negative predictive value, positive predictive value and accuracy) between the four FNB needles in patients undergoing EUS-guided sampling of pancreatic masses using the three different sampling techniques
6 months

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 (Actual)

September 9, 2019

Primary Completion (Actual)

June 25, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

September 9, 2019

First Submitted That Met QC Criteria

September 9, 2019

First Posted (Actual)

September 11, 2019

Study Record Updates

Last Update Posted (Actual)

August 5, 2020

Last Update Submitted That Met QC Criteria

August 3, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1469116

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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