Biopsy, NeedleNCT05434247
Comparing the Diagnostic Adequacy of 25-gauge Fork-tip, Franseen and Reverse-bevel Type Needles in Endoscopic Ultrasound Guided Tissue Acquisition
A study testing Needle choice in people with Biopsy, Needle, run by Princess Alexandra Hospital, Brisbane, Australia at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Biopsy, Needle
- What is being tested?
- Needle choice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Sep 2018to 1 Sep 2020
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any solid tissue biopsy performed at the time of endoscopic ultrasound
Who cannot join
- Fluid samples were excluded.
- Cases where biopsy was not deemed necessary by the proceduralist based on endosonographic findings
- Cases where biopsy was deemed unsafe
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read more
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.
- Conditions
- Biopsy, Needle
- Being tested
- Needle choice
- Keywords
- Endoscopic ultrasound, Fine Needle Biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needle choiceDevice
The type of needle use was the only intervention
| Study group | Role | What they receive |
|---|---|---|
| Reverse-bevel ProCore™ | Other | 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. Receives: Device: Needle choice |
| Fork-tip SharkCore™ | Experimental | 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. Receives: Device: Needle choice |
| Franseen Acquire™ | Experimental | 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. Receives: Device: Needle choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield
The percentage of lesions sampled for which a tissue diagnosis was obtained
Measured: At study completion, approximately 1 year after final subject enrolled
Secondary outcomes (3)
Number of needle passes
Measured: At study completion, approximately 1 year after final subject enrolled
Sample bloodiness
A subjective assessment of the amount of blood seen on histopathological specimens (1 = no interference with interpretation, 2 = interference with interpretation but diagnosis can still be made, 3 = excessive blood makes assessment impossible)
Measured: At study completion, approximately 1 year after final subject enrolled
Target tissue cellularity
Subjective assessment by histopathologist of the cellularity of the sample (consisting of cells from the target lesion) - low, medium or high.
Measured: At study completion, approximately 1 year after final subject enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start1 Sep 2018
- Primary completion1 Sep 2019
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biopsy, NeedleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Randomized trial with retrospective comparator group
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Princess Alexandra Hospital, Brisbane, Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Huelsen, Princess Alexandra Hospital, Brisbane, Australia
- Investigators
- Alexander Huelsen, MD, Study director, QLD Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434247
- Sponsor's protocol ID
- LNR/QMS/44303
- Status last verified
- Jun 2022
- First submitted
- 19 Mar 2022
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05434247
- Acronym / sponsor ID
- LNR/QMS/44303
- Conditions
- Biopsy, Needle
- Keywords
- Endoscopic ultrasound, Fine Needle Biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Princess Alexandra Hospital, Brisbane, AustraliaUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized trial with retrospective comparator group
| Arm | Type | Receives |
|---|---|---|
| Reverse-bevel ProCore™ | Other | Device: Needle choiceHistorical 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. |
| Fork-tip SharkCore™ | Experimental | Device: Needle choiceExperimental 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. |
| Franseen Acquire™ | Experimental | Device: Needle choiceExperimental 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any solid tissue biopsy performed at the time of endoscopic ultrasound
Key exclusion criteria (3 listed)
- Fluid samples were excluded.
- Cases where biopsy was not deemed necessary by the proceduralist based on endosonographic findings
- Cases where biopsy was deemed unsafe
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Needle choiceThe type of needle use was the only intervention | Device | Fork-tip SharkCore™, Franseen Acquire™, Reverse-bevel ProCore™ |
Primary outcome
Diagnostic yield
Time frame: At study completion, approximately 1 year after final subject enrolled
The percentage of lesions sampled for which a tissue diagnosis was obtained
3 secondary outcomes
Number of needle passes
Time frame: At study completion, approximately 1 year after final subject enrolled
Sample bloodiness
Time frame: At study completion, approximately 1 year after final subject enrolled
Target tissue cellularity
Time frame: At study completion, approximately 1 year after final subject enrolled
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Huelsen, MD study director
QLD Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Needle choice in people with Biopsy, Needle, run by Princess Alexandra Hospital, Brisbane, Australia at 1 site in Australia.
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 1 inclusion and 3 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 27 Jun 2022. 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 Australia. 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?
Diagnostic yield (time frame: At study completion, approximately 1 year after final subject enrolled). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2022.