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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05434247




Registration number
NCT05434247
Ethics application status
Date submitted
19/03/2022
Date registered
27/06/2022
Date last updated
27/06/2022

Titles & IDs
Public title
Comparing the Diagnostic Adequacy of 25-gauge Fork-tip, Franseen and Reverse-bevel Type Needles in Endoscopic Ultrasound Guided Tissue Acquisition
Scientific title
A Prospective Randomized Study Comparing the Diagnostic Adequacy of 25-gauge Fork-tip, Franseen and Reverse-bevel Type Needles in Endoscopic Ultrasound Guided Tissue Acquisition
Secondary ID [1] 0 0
LNR/QMS/44303
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Biopsy, Needle 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Needle choice

Other: Reverse-bevel ProCore™ - Historical comparator group of biopsies taken using Echo Tip® HD ProCore™ (Wilson-Cook Medical Inc., Winston-Salem, NC, United States) biopsy needle. Slow pull stylet technique with rapid on site evaluation in all cases.

Experimental: Fork-tip SharkCore™ - Experimental group of biopsies using SharkCore™ (Medtronic Inc., Sunnyvale, CA, United States) biopsy needle. Slow pull stylet technique with rapid on site evaluation in all cases.

Experimental: Franseen Acquire™ - Experimental group of biopsies using Acquire™ (Boston Scientific, Marlborough, MA, United States) biopsy needle. Slow pull stylet technique with rapid on site evaluation in all cases.


Treatment: Devices: Needle choice
The type of needle use was the only intervention
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Diagnostic yield
Timepoint [1] 0 0
At study completion, approximately 1 year after final subject enrolled
Secondary outcome [1] 0 0
Number of needle passes
Timepoint [1] 0 0
At study completion, approximately 1 year after final subject enrolled
Secondary outcome [2] 0 0
Sample bloodiness
Timepoint [2] 0 0
At study completion, approximately 1 year after final subject enrolled
Secondary outcome [3] 0 0
Target tissue cellularity
Timepoint [3] 0 0
At study completion, approximately 1 year after final subject enrolled

Eligibility
Key inclusion criteria
- Any solid tissue biopsy performed at the time of endoscopic ultrasound
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Fluid samples were excluded.

- Cases where biopsy was not deemed necessary by the proceduralist based on
endosonographic findings

- Cases where biopsy was deemed unsafe

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2020
Sample size
Target
Accrual to date
Final
178
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
4102 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
Princess Alexandra Hospital, Brisbane, Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Endoscopic ultrasound guided fine needle aspiration (EUS-FNA) and fine needle biopsy
(EUS-FNB) are well established techniques for the acquisition of tissue to classify a number
of lesions of the gastrointestinal tract and surrounding organs. These include pancreatic,
lymphoid, subepithelial and other abdominal lesions. Historically, FNA was the sole available
modality used to obtain cytological samples for analysis. The major shortcoming of this
technique is the lack of a histological tissue core.

In recent years attention has turned to optimizing needle design to improve sample quality.
New needles have been developed which aim to obtain a core of tissue with preserved
architecture.

These needles include the first generation Reverse-bevel Echo Tip® HD ProCore™ (Wilson-Cook
Medical Inc., Winston-Salem, NC, United States), and the second generation Fork-tip
SharkCore™ (Medtronic Inc., Sunnyvale, CA, United States) and Franseen Acquire™ (Boston
Scientific, Marlborough, MA, United States).

Currently there are a paucity of studies comparing the performance of these needles, and only
two of these are prospective randomized controlled trials. Real world performance of these
needles has seldom been reported, with only one RCT including non-pancreatic masses in their
analysis.

The investigators hypothesize that second generation needles have equivalent or better
diagnostic performance than the prior first-generation needle.

To test this, the investigators aim to conduct a prospective randomized controlled study
comparing the performance of Fork-tip and Franseen needles for the sampling of pancreatic,
subepithelial, lymphoid and other abdominal or mediastinal lesions. They also aim to include
a retrospective control arm of consecutive cases using the first-generation Reverse-bevel
needle.

The investigatora aim to assess the diagnostic yield of each needle, as well as number of
needle passes used, and specimen quality.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05434247
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alexander Huelsen, MD
Address 0 0
QLD Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries