Pancreatic MassesASPRONCT02167074
Comparing a 25G EUS Fine Needle Aspiration (FNA) Device With a 20G EUS
A study testing 25G FNA needle and 20G ProCore FNB needle in people with Pancreatic Masses and Lymph Nodes, run by Foundation for Liver Research at 13 sites in 10 countries.
Trial summary
The aim of this study is to compare the diagnostic accuracy of two EUS-guided tissue acquisition devices; the 25G Echotip Ultra Fine Needle Aspiration (FNA) device and the 20G Echotip ProCore Fine Needle Biopsy (FNB) device. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pancreatic Masses, Lymph Nodes
- What is being tested?
- 25G FNA needle and 20G ProCore FNB needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 615 participants
- Where
- 13 sitesin 10 countries
- Study dates
- Feb 2015to 1 Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred for EUS-guided tissue acquisition because of a (I) pancreatic mass lesion or (II) lymph node
- Age > 18 years
- Written informed consent
- Lesion can be visualized with EUS and is ≥1 cm in size
Who cannot join
- Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma (FFP)
- Use of anticoagulants that cannot be discontinued in order to guarantee an INR below 1.5
- Purely cystic lesions
- Previous inclusion in the current study
- Pregnancy
Trial locations and contacts
13 sites in 10 countries.
13 sites in 10 countries
United States3 sites
University of California
Irvine, California, CA 92868
Yale University School of Medicine
New Haven, Connecticut, CT 06520
Stony Brook University Hospital
New York, New York, NY 11794
Italy2 sites
Vita Salute San Raffaele University
Milan
Catholic University Rome
Rome
Netherlands1 site
Erasmus University Medical Center
Rotterdam, South Holland, 3015 CE
Spain1 site
University Hospital of Santiago de Compostella
Santiago de Compostela
About this study
Official title: A Multicenter Randomized Trial, Comparing a 25G EUS Fine Needle Aspiration (FNA) Device With a 20G EUS ProCore Fine Needle Biopsy (FNB) Device
The aim of this study is to compare the diagnostic accuracy of two EUS-guided tissue acquisition devices; the 25G Echotip Ultra Fine Needle Aspiration (FNA) device and the 20G Echotip ProCore Fine Needle Biopsy (FNB) device.
Read the detailed description
Endoscopic ultrasound (EUS)-guided tissue acquisition has emerged as a valuable method to diagnose and stage malignancies. During Endoscopic Ultrasound (EUS), tissue samples can be obtained for pathological evaluation with different devices. Fine needle aspiration (FNA) provides a cytological specimen. Unfortunately, in a cytological specimen, inflammatory changes may be undistinguishable from well-differentiated dysplasia. Moreover, for neoplasms such as lymphomas and stromal tumors, tissue architecture and cell morphology are essential for accurate pathological assessment. Therefore, pathologists generally prefer a histological specimen. Fine needle biopsy (FNB) has the advantage of obtaining a histological specimen, which may lead to better diagnostic performance. However, FNB needles are stiffer and more difficult to handle, which can complicate tissue acquisition. In addition, the superiority of histology over cytology in EUS-guided tissue sampling has not been proven yet. For instance, tissue, obtained by FNA and processed with the new cell-block technique, may equal the diagnostic yield of histological tissue cores.
A recent meta-analysis suggested that 25G is the optimal FNA needle size to obtain an adequate cytological specimen. In this study, we aim to compare the properties and merits of a newly designed, more flexible, 20G EUS ProCore FNB device to a conventional 25G EUS-FNA device.
- Conditions
- Pancreatic Masses, Lymph Nodes
- Being tested
- 25G FNA needle, 20G ProCore FNB needle
- Keywords
- Diagnostic accuracy, Endoscopic Ultrasound-Guided Fine Needle Aspiration, EUS-FNA, Endoscopic Ultrasound-Guided Fine Needle Biopsy, EUS-FNB, Pancreatic mass, Lymph node
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25G FNA needleDevice
Also called 25G Echotip Ultra Fine Needle Aspiration (FNA) device
20G ProCore FNB needleDevice
Also called 20G Echotip ProCore Fine Needle Biopsy (FNB) device
| Study group | Role | What they receive |
|---|---|---|
| 25G FNA needle | Active comparator | Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic). Receives: Device: 25G FNA needle |
| 20G ProCore FNB needle | Active comparator | Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic). Receives: Device: 20G ProCore FNB needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy
Diagnostic accuracy is the number of correctly diagnosed cases as compared to gold standard diagnosis
Gold standard diagnosis is defined as;
- in operated patients; based on the surgical resection specimen
- in non-operated patients; based on the conclusions of the diagnostic work-up (combined outcomes of tissue sampling and imaging studies), and confirmed by a compatible clinical disease course of at least 9 months
Measured: 27 months
Secondary outcomes (5)
Number of Participants in Whom Target Lesion Was Sampled
records if a target lesion was reached during the procedure using the randomised needle or not
Measured: 1 day
Presence of Vital Target Cells Per Case, Per Needle Type
Presence of sufficient vital target cells, as in, target organ cells to provide a diagnosis (yes or no)
Measured: after 27 months
Number of Patients With Adverse Events Per Needle Type
adverse events per needle type, up to 27 months after procedure
Measured: 27 months after procedure
Diagnostic Yield of the First Needle Pass
Yield is expressed as sample sufficiency for diagnostic analysis by pathologists, this was either sufficient or not
Measured: after 27 months
On-site Pathological Evaluation Performed
Presence of pathologist on site during procedure
Measured: 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startFeb 2015
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatic MassesStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 615 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Liver Research
- Sponsor type
- University, hospital or other
- Collaborators
- Cook Ireland, Ltd.
- Responsible party
- Sponsor
- Investigators
- Marco J Bruno, MD, PhD, Study chair, Erasmus Medical CenterDjuna L Cahen, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167074
- Sponsor's protocol ID
- ASPRO-2014-01
- Acronym
- ASPRO
- Status last verified
- Aug 2021
- First submitted
- 12 Jun 2014
- Last updated
- 23 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
van Riet PA, Giorgio Arcidiacono P, Petrone M, Quoc Nguyen N, Kitano M, Chang K, Larghi A, Iglesias-Garcia J, Giovannini M, van der Merwe S, Santo E, Baldaque-Silva F, Bucobo JC, Bruno MJ, Aslanian HR, Cahen DL, Farrell J. Combined versus single use 20 G fine-needle biopsy and 25 G fine-needle aspiration for endoscopic ultrasound-guided tissue sampling of solid gastrointestinal lesions. Endoscopy. 2020 Jan;52(1):37-44. doi: 10.1055/a-0966-8755. Epub 2019 Jul 22.
PubMed 31330556van Riet PA, Larghi A, Attili F, Rindi G, Nguyen NQ, Ruszkiewicz A, Kitano M, Chikugo T, Aslanian H, Farrell J, Robert M, Adeniran A, Van Der Merwe S, Roskams T, Chang K, Lin F, Lee JG, Arcidiacono PG, Petrone M, Doglioni C, Iglesias-Garcia J, Abdulkader I, Giovannini M, Bories E, Poizat F, Santo E, Scapa E, Marmor S, Bucobo JC, Buscaglia JM, Heimann A, Wu M, Baldaque-Silva F, Moro CF, Erler NS, Biermann K, Poley JW, Cahen DL, Bruno MJ. A multicenter randomized trial comparing a 25-gauge EUS fine-needle aspiration device with a 20-gauge EUS fine-needle biopsy device. Gastrointest Endosc. 2019 Feb;89(2):329-339. doi: 10.1016/j.gie.2018.10.026. Epub 2018 Oct 24.
PubMed 30367877
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Trial, Comparing a 25G EUS Fine Needle Aspiration (FNA) Device With a 20G EUS ProCore Fine Needle Biopsy (FNB) Device
- ClinicalTrials.gov ID
- NCT02167074
- Acronym / sponsor ID
- ASPRO / ASPRO-2014-01
- Conditions
- Pancreatic Masses, Lymph Nodes
- Keywords
- Diagnostic accuracy, Endoscopic Ultrasound-Guided Fine Needle Aspiration, EUS-FNA, Endoscopic Ultrasound-Guided Fine Needle Biopsy, EUS-FNB, Pancreatic mass, Lymph node
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 615 participants (actual)
- Lead sponsor
- Foundation for Liver ResearchUniversity, hospital or other
- Collaborators
- Cook Ireland, Ltd.
- Study start
- Feb 2015 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 18 Jun 2014 (estimated)
- Results
- Posted 25 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare the diagnostic accuracy of two EUS-guided tissue acquisition devices; the 25G Echotip Ultra Fine Needle Aspiration (FNA) device and the 20G Echotip ProCore Fine Needle Biopsy (FNB) device.
Detailed description
Endoscopic ultrasound (EUS)-guided tissue acquisition has emerged as a valuable method to diagnose and stage malignancies. During Endoscopic Ultrasound (EUS), tissue samples can be obtained for pathological evaluation with different devices. Fine needle aspiration (FNA) provides a cytological specimen. Unfortunately, in a cytological specimen, inflammatory changes may be undistinguishable from well-differentiated dysplasia. Moreover, for neoplasms such as lymphomas and stromal tumors, tissue architecture and cell morphology are essential for accurate pathological assessment. Therefore, pathologists generally prefer a histological specimen. Fine needle biopsy (FNB) has the advantage of obtaining a histological specimen, which may lead to better diagnostic performance. However, FNB needles are stiffer and more difficult to handle, which can complicate tissue acquisition. In addition, the superiority of histology over cytology in EUS-guided tissue sampling has not been proven yet. For instance, tissue, obtained by FNA and processed with the new cell-block technique, may equal the diagnostic yield of histological tissue cores.
A recent meta-analysis suggested that 25G is the optimal FNA needle size to obtain an adequate cytological specimen. In this study, we aim to compare the properties and merits of a newly designed, more flexible, 20G EUS ProCore FNB device to a conventional 25G EUS-FNA device.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 25G FNA needle | Active comparator | Device: 25G FNA needlePatients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic). |
| 20G ProCore FNB needle | Active comparator | Device: 20G ProCore FNB needlePatients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients referred for EUS-guided tissue acquisition because of a (I) pancreatic mass lesion or (II) lymph node
- Age > 18 years
- Written informed consent
- Lesion can be visualized with EUS and is ≥1 cm in size
Key exclusion criteria (5 listed)
- Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma (FFP)
- Use of anticoagulants that cannot be discontinued in order to guarantee an INR below 1.5
- Purely cystic lesions
- Previous inclusion in the current study
- Pregnancy
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 |
|---|---|---|
| 25G FNA needleAlso: 25G Echotip Ultra Fine Needle Aspiration (FNA) device | Device | 25G FNA needle |
| 20G ProCore FNB needleAlso: 20G Echotip ProCore Fine Needle Biopsy (FNB) device | Device | 20G ProCore FNB needle |
Primary outcome
Diagnostic Accuracy
Time frame: 27 months
Diagnostic accuracy is the number of correctly diagnosed cases as compared to gold standard diagnosis Gold standard diagnosis is defined as; 1. in operated patients; based on the surgical resection specimen 2. in non-operated patients; based on the conclusions of the diagnostic work-up (combined outcomes of tissue sampling and imaging studies), and confirmed by a compatible clinical disease course of at least 9 months
5 secondary outcomes
Number of Participants in Whom Target Lesion Was Sampled
Time frame: 1 day
Presence of Vital Target Cells Per Case, Per Needle Type
Time frame: after 27 months
Number of Patients With Adverse Events Per Needle Type
Time frame: 27 months after procedure
Diagnostic Yield of the First Needle Pass
Time frame: after 27 months
On-site Pathological Evaluation Performed
Time frame: 27 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31330556van Riet PA, Giorgio Arcidiacono P, Petrone M, Quoc Nguyen N, Kitano M, Chang K, Larghi A, Iglesias-Garcia J, Giovannini M, van der Merwe S, Santo E, Baldaque-Silva F, Bucobo JC, Bruno MJ, Aslanian HR, Cahen DL, Farrell J. Combined versus single use 20 G fine-needle biopsy and 25 G fine-needle aspiration for endoscopic ultrasound-guided tissue sampling of solid gastrointestinal lesions. Endoscopy. 2020 Jan;52(1):37-44. doi: 10.1055/a-0966-8755. Epub 2019 Jul 22.
- Derived from this study: PubMed 30367877van Riet PA, Larghi A, Attili F, Rindi G, Nguyen NQ, Ruszkiewicz A, Kitano M, Chikugo T, Aslanian H, Farrell J, Robert M, Adeniran A, Van Der Merwe S, Roskams T, Chang K, Lin F, Lee JG, Arcidiacono PG, Petrone M, Doglioni C, Iglesias-Garcia J, Abdulkader I, Giovannini M, Bories E, Poizat F, Santo E, Scapa E, Marmor S, Bucobo JC, Buscaglia JM, Heimann A, Wu M, Baldaque-Silva F, Moro CF, Erler NS, Biermann K, Poley JW, Cahen DL, Bruno MJ. A multicenter randomized trial comparing a 25-gauge EUS fine-needle aspiration device with a 20-gauge EUS fine-needle biopsy device. Gastrointest Endosc. 2019 Feb;89(2):329-339. doi: 10.1016/j.gie.2018.10.026. Epub 2018 Oct 24.
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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.
Marco J Bruno, MD, PhD study chair
Erasmus Medical Center
Djuna L Cahen, MD, PhD principal investigator
Erasmus Medical Center
13 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 25G FNA needle and 20G ProCore FNB needle in people with Pancreatic Masses and Lymph Nodes, run by Foundation for Liver Research at 13 sites in 10 countries.
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 4 inclusion and 5 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 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Italy, Australia, Belgium, France and 5 more countries. 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?
Yes. Results are posted in the registry (first posted 25 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Accuracy (time frame: 27 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02167074, which also lists 2 linked publications.
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 23 Aug 2021.