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Trial registered on ANZCTR
Registration number
ACTRN12626001140347
Ethics application status
Approved
Date submitted
24/07/2026
Date registered
14/09/2026
Date last updated
14/09/2026
Date data sharing statement initially provided
14/09/2026
Type of registration
Prospectively registered
Titles & IDs
Public title
A study comparing three types of biopsy needles in patients with pancreatic lesions undergoing endoscopic ultrasound-guided tissue sampling
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Scientific title
Multi-center randomized non-inferiority trial comparing dual-bevel raptor tip needle (SecureFlex) versus the Franseen tip (Acquire and Clear-core) needle versus Tri-prong tip (Trident) needle for EUS-guided fine-needle biopsy of solid pancreatic lesions
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Additional trial identifiers [1]
317932
0
Nil
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Universal Trial Number (UTN)
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Trial acronym
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Related trial records
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Health condition
Health condition(s) studied:
Pancreatic Cancer
342885
0
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Condition category
Condition code
Cancer
338998
338998
0
0
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Pancreatic
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Surgery
339380
339380
0
0
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Surgical techniques
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Intervention/exposure
Study type
Interventional
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Description of the intervention or exposure
This is a prospective, multi-centre, randomised controlled trial involving adults with solid pancreatic lesions greater than 1 cm who require endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) as part of standard clinical care. The study does not introduce an experimental treatment or additional invasive procedure; the study-specific intervention is randomisation to one of three commercially available 22G FNB needle types used for the clinically indicated EUS-FNB procedure.
Participants will be randomised in a 1:1:1 ratio to one of the following needle groups:
1. 22G SecureFlex dual-bevel Raptor-tip needle (Olympus)
2. 22G Trident 3-prong-tip needle (Micro-Tech Endoscopy)
3. 22G Franseen-tip needle (Acquire [Boston Scientific] or ClearCore [Cook Medical])
Pre-procedure: Participants will undergo the usual clinical assessment required before EUS-FNB, including confirmation of eligibility, review of relevant medical history, medications and bleeding risk, and assessment of available imaging and clinical information. Written informed consent for the study will be obtained before randomisation and the EUS-FNB procedure.
During the procedure: EUS will be performed by an appropriately trained and credentialed gastroenterologist/endoscopist, with assistance from nursing staff and an anaesthetist or appropriately trained sedation practitioner as required according to local institutional practice. The pancreatic lesion will be assessed using standard EUS techniques. Doppler assessment will be used to identify and avoid intervening vascular structures. Contrast-enhanced EUS and/or elastography may be used at the discretion of the endoscopist where clinically appropriate.
Following EUS assessment, the participant will undergo EUS-FNB using the needle type allocated through randomisation. Standard EUS-FNB techniques, including fanning and avoidance of vascular structures, will be used. The use of suction will be at the discretion of the endoscopist. Each needle pass will involve advancing the needle into the pancreatic lesion and performing at least 10 ‘back-and-forth’ needle movements before withdrawing the needle and collecting the tissue specimen.
The first three needle passes form part of the same EUS-FNB procedure and are performed sequentially during the same procedure. They do not represent separate visits or separate procedures and are not required to target different pancreatic lesions. Each pass will be numbered sequentially (Pass 1, Pass 2 and Pass 3), with the endoscopist targeting the appropriate area of the pancreatic lesion based on EUS findings. Macroscopic on-site evaluation (MOSE) will be performed after each pass to assess the tissue obtained, including the presence and length of visible white core tissue. The core length from each pass will be recorded. A pass will be considered adequate when the measured core is greater than/equal to 11 mm. If adequate tissue cannot be obtained after three passes, additional passes may be performed, up to a maximum of five passes, where considered clinically necessary and safe to obtain a tissue diagnosis.
The procedure will be performed as part of standard clinical care and will generally take the time required for a routine EUS-FNB procedure. The actual procedural time will be recorded for the study. Tissue specimens will undergo routine histopathological assessment by the participating site's designated pathologist, including assessment of quantity, quality, blood contamination and diagnostic findings.
Post-procedure: Participants will receive routine post-EUS-FNB clinical care and monitoring and will be reviewed prior to discharge. A further assessment will occur approximately 24 hours after the procedure, followed by assessments at 30 days, 3 months and 6 months. These assessments will record clinical outcomes, procedure-related complications, diagnostic outcomes and whether any repeat tissue acquisition procedure was required. The pre-discharge and 24-hour assessments will be undertaken as part of the participant's clinical review where possible; the 30-day, 3-month and 6-month assessments may be performed during routine clinical review and/or by telephone or medical record review where appropriate. Each follow-up assessment is expected to take approximately 5–15 minutes, depending on the participant's clinical circumstances.
If the initial EUS-FNB does not provide a definitive diagnosis, any repeat EUS-FNB or other diagnostic procedure will be undertaken only where clinically indicated and in accordance with the treating clinician's usual practice. Repeat procedures are not performed solely because of participation in the study. Where a repeat procedure occurs, relevant clinical and diagnostic outcomes will be recorded for the study.
The intervention will be delivered once for each participant during the initial clinically indicated EUS-FNB procedure. The total study follow-up period is 6 months.
Intervention adherence and fidelity: Adherence to the allocated intervention will be assessed through study records and procedure documentation. The allocated needle type, needle gauge, number of passes, core length, procedural time, use of suction and other protocol-required procedural assessments will be recorded. Deviations from the allocated needle type or other protocol requirements will be documented and reviewed by the study team. Participating sites will use standardised study data collection procedures, with data entered into the site's approved electronic data capture system and subject to central data review by the coordinating study team.
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Intervention code [1]
334788
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Diagnosis / Prognosis
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Description of the comparator or control
Participants randomised to the comparator group will undergo EUS-guided fine-needle biopsy using a commercially available 22G Franseen-tip needle (Acquire or ClearCore).
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Control group
Active
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Outcomes
Primary outcome [1]
346243
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Diagnostic Yield between needle types.
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Assessment method [1]
346243
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Diagnostic yield will be assessed based on the adequacy of the tissue specimen obtained by EUS-FNB, as determined by histopathological assessment. Specimens will be classified as adequate or non-adequate for establishing a histological diagnosis. The proportion of participants with an adequate diagnostic specimen will be compared between the three randomised needle groups.
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Timepoint [1]
346243
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Individual participant diagnostic yield assessed within 1 week of specimen collection.
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Secondary outcome [1]
465157
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Diagnostic accuracy between the needles types.
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Assessment method [1]
465157
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Diagnostic accuracy will be determined by comparing the histopathological diagnosis obtained from EUS-FNB with the participant's final diagnosis, established according to the protocol-defined criteria using surgical histology, repeat EUS-FNB with compatible clinical course, or clinical and radiological follow-up of at least 6 months where applicable. Diagnostic accuracy will also be assessed according to the number of needle passes (1, 2 and 3).
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Timepoint [1]
465157
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Individual assessment obtained within 1 week of sample collection. Full assessment up to 6 months after the EUS-FNB procedure.
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Secondary outcome [2]
465158
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Core tissue length obtained per needle pass, taken from 1st, 2nd, and 3rd passes.
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Assessment method [2]
465158
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The length of the visible white core obtained from each of the first three EUS-FNB passes will be measured (in mm) during macroscopic on-site evaluation and recorded in the study records. Core length will be compared between the three needle groups for Pass 1, Pass 2 and Pass 3.
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Timepoint [2]
465158
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Assessed immediately following each of the first three needle passes during the EUS-FNB procedure.
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Secondary outcome [3]
465159
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Tissue characteristics between the 3 needle types (includes three characteristics being predefined components).
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Assessment method [3]
465159
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Tissue characteristics will be assessed independently from the histopathology report. Specimens will be assessed for quantity (Grade 0–2), quality (Grade 0–2), and blood contamination (Grade 0–2), using the predefined histological assessment criteria. A separate histologic assessment score (0–2) will be assigned based on the overall quantity and quality of the tissue obtained. Tissue collection rate will be assessed separately as a secondary outcome.
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Timepoint [3]
465159
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Histopathological assessment performed within 1 week of specimen collection.
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Secondary outcome [4]
465160
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Initial Puncture Feasibility
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Assessment method [4]
465160
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Initial puncture success will be assessed from the endoscopist's procedural assessment during EUS-FNB and recorded in the procedure as "Yes/No". Success defined as 'successful puncture of the target lesion on the first attempt without the needle slipping or pushing against the gastrointestinal mucosa', confirmed by EUS visualisation.
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Timepoint [4]
465160
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Assessed immediately following completion of the EUS-FNB procedure on the day of the procedure.
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Secondary outcome [5]
465161
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Tissue collection rate
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Assessment method [5]
465161
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Assessed by comparing the histological assessment outcomes, and defined as the proportion of procedures yielding sufficient tissue samples (score of 1 or 2). Information to calculate rate obtained from histopathology report.
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Timepoint [5]
465161
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Individual assessment obtained within 1 week of sample collection.
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Secondary outcome [6]
465162
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Procedural Time
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Assessment method [6]
465162
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Total procedural time will be recorded in minutes from the commencement of the EUS-FNB procedure until completion of the procedure, based on the procedure record.
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Timepoint [6]
465162
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Recorded immediately following completion of the EUS-FNB procedure on the day of the procedure.
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Secondary outcome [7]
465165
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Need for repeat procedure.
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Assessment method [7]
465165
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Assessed through review of medical records, procedure reports and study follow-up records to determine whether an additional diagnostic/tissue acquisition procedure was required following the initial EUS-FNB. The occurrence of a repeat procedure will be recorded as "Yes/No" and compared between the three needle groups.
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Timepoint [7]
465165
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Assessed at six month after the initial EUS-FNB.
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Secondary outcome [8]
465167
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Complication rate comparisons between three needle type cohorts. (This is a composite secondary outcome comprising bleeding, perforation and pancreatitis. Each complication will also be recorded individually and the overall complication rate will be compared between the three needle groups.)
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Assessment method [8]
465167
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Assessed through review of procedure records, medical records and clinical follow-up at the participating site.
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Timepoint [8]
465167
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Complications will be assessed from the time of the EUS-FNB procedure through 6 months of follow-up using procedure records, medical records and participant clinical follow-up.
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Secondary outcome [9]
467013
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Puncture performance
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Assessment method [9]
467013
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Endoscopist-assessed puncture performance using a 5-point visual analogue scale (VAS), ranging from 1 (very easy) to 5 (very difficult).
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Timepoint [9]
467013
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Assessed immediately following completion of the EUS-FNB procedure on the day of the procedure.
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Eligibility
Key inclusion criteria
Patients requiring endoscopic ultrasound and tissue sampling of solid lesions greater than 1cm diameter int he pancreas that are visualised wand within the reach of Endoscopic Ultrasound Fine Needle Aspiration
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Healthy volunteers
No
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Key exclusion criteria
1. Pregnant females,
2. Uncorrectable coagulation disorder (INR > 1.5)
3. Those with medical co-morbidities that preclude them from sedation (as determined by anaesthetic team)
4. Actively on medications that increase the risk of bleeding from EUS guided tissue acquisition (NOAC, warfarin, combined aspirin and clopidogrel). Aspirin (100mg daily) alone is allowed in cases where antiplatelet therapy is critical such as recurrent stroke/CVA and in-situ coronary stent.
5. Those unable to give informed consent
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation blocks will be generated and site will abide by randomisation allocation patient-by-patient. Blocks of size 30 will be created to ensure equal allocation to one of the three groups.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
16/09/2026
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
780
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA,WA,VIC
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Recruitment outside Australia
Country [1]
28340
0
Hong Kong
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State/province [1]
28340
0
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Country [2]
28341
0
New Zealand
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State/province [2]
28341
0
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Country [3]
28342
0
Thailand
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State/province [3]
28342
0
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Country [4]
28343
0
Singapore
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State/province [4]
28343
0
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Country [5]
28344
0
India
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State/province [5]
28344
0
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Country [6]
28376
0
Japan
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State/province [6]
28376
0
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Funding & Sponsors
Funding source category [1]
322483
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Hospital
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Name [1]
322483
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Royal Adelaide Hospital
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Address [1]
322483
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Country [1]
322483
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Australia
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Primary sponsor type
Hospital
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Name
Royal Adelaide Hospital
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Address
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Country
Australia
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Secondary sponsor category [1]
325397
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None
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Name [1]
325397
0
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Address [1]
325397
0
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Country [1]
325397
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
320959
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Central Adelaide Local Health Network HREC
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Ethics committee address [1]
320959
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https://www.rah.sa.gov.au/research/for-researchers/central-adelaide-local-health-network-human-research-ethics-committee
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Ethics committee country [1]
320959
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Australia
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Date submitted for ethics approval [1]
320959
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18/03/2026
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Approval date [1]
320959
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23/07/2026
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Ethics approval number [1]
320959
0
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Summary
Brief summary
This study is comparing three different types of biopsy needles used during an endoscopic ultrasound (EUS) procedure to collect tissue samples from solid pancreatic lesions Who is it for? You may be eligible to join this study if you are aged 18 years or above and require endoscopic ultrasound and tissue sampling of solid lesions in the pancreas for assessment of suspected pancreatic cancer. Study details All three needles used in the study are commercially available and routinely used in clinical practice, but it is not yet known which provides the best tissue sample for making an accurate diagnosis. Participants will be randomly allocated to one of the three needle types during their standard-of-care endoscopic ultrasound procedure. The study will compare how well each needle performs in obtaining tissue for diagnosis, how easy it is to use, and how safe it is. The Endoscopic Ultrasound Fine Needle Aspiration procedure will be assessed for the length of core sample taken, accuracy of diagnosis, tissue characteristics, and procedural time. It is hoped that the results from this study may help identify the most effective needle for EUS-guided tissue sampling and improve the diagnosis and management of patients with pancreatic lesions.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
152202
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Prof Nam Nguyen
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Address
152202
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Royal Adelaide Hospital, Port Road, Adelaide, SA 5000
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Country
152202
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Australia
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Phone
152202
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+61 8 70742142
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Fax
152202
0
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Email
152202
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[email protected]
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Contact person for public queries
Name
152203
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Joshua Zobel
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Address
152203
0
Royal Adelaide Hospital, Port Road, Adelaide, SA 5000
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Country
152203
0
Australia
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Phone
152203
0
+61 8 70742188
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Fax
152203
0
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Email
152203
0
[email protected]
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Contact person for scientific queries
Name
152204
0
Joshua Zobel
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Address
152204
0
Royal Adelaide Hospital, Port Road, Adelaide, SA 5000
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Country
152204
0
Australia
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Phone
152204
0
+61 8 70742188
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Fax
152204
0
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Email
152204
0
[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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