Pancreatic NeoplasmsNCT02920944
Diagnostic Yield of 20-gauge Procore Needle for EUS-guided FNA Biopsy in Solid Pancreatic Lesions
A study testing EUS-FNB with 20 gauge ProCore needle and EUS-FNB with 22 gauge ProCore needle in people with Pancreatic Neoplasms, run by Seung Bae Yoon at 1 site in South Korea.
Trial summary
This study aims to examine technical feasibility and diagnostic yield of new 20-gauge Procore needle for EUS-guided fine needle biopsy in solid lesions by comparing with 22-gauge Procore needle. The study design is prospective, randomized study. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- EUS-FNB with 20 gauge ProCore needle and EUS-FNB with 22 gauge ProCore needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2016to Oct 2017
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 20 years referred to our medical center for EUS-FNB with diagnosed or suspected solid pancreatic masses according to clinical evaluation and imaging studies.
Who cannot join
- cystic pancreatic lesions, patients haemodynamically unstable or with severe coagulopathy (international normalized ratio [INR] > 1.5 or platelet count < 50,000 cells/cubic millimeter [cmm3]), patients unable to suspend anticoagulant/anti-platelet therapy, pregnancy, inability or refusal to give informed consent, and refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Technical Feasibility and Diagnostic Yield of New 20-gauge Procore Needle for EUS-guided FNA Biopsy in Solid Pancreatic Lesions; Comparison With 22-gauge Procore Needle
This study aims to examine technical feasibility and diagnostic yield of new 20-gauge Procore needle for EUS-guided fine needle biopsy in solid lesions by comparing with 22-gauge Procore needle. The study design is prospective, randomized study.
- Conditions
- Pancreatic Neoplasms
- Being tested
- EUS-FNB with 20 gauge ProCore needle, EUS-FNB with 22 gauge ProCore needle
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-FNB with 20 gauge ProCore needleDevice
EUS-FNB with 20-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)
EUS-FNB with 22 gauge ProCore needleDevice
EUS-FNB with 22-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)
| Study group | Role | What they receive |
|---|---|---|
| EUS-FNB with 20-gauge | Experimental | EUS-FNB with 20-gauge procore needle Receives: Device: EUS-FNB with 20 gauge ProCore needle |
| EUS-FNB with 22-gauge | Active comparator | EUS-FNB with 22-gauge procore needle Receives: Device: EUS-FNB with 22 gauge ProCore needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
single diagnostic yield of the histologic core
Measured: up to 5 minutes after endoscopic ultrasound-guided fine needle biopsy
Secondary outcomes (1)
total diagnostic yield of the histologic core
Measured: up to 5 minutes after endoscopic ultrasound-guided fine needle biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung Bae Yoon
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul St. Mary's Hospital
- Responsible party
- Sponsor-investigator, Seung Bae Yoon, Seoul St. Mary's Hospital
- Investigators
- In Seok Lee, MD, Study director, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920944
- Sponsor's protocol ID
- EUS 20 gauge
- Status last verified
- Oct 2017
- First submitted
- 28 Sep 2016
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technical Feasibility and Diagnostic Yield of New 20-gauge Procore Needle for EUS-guided FNA Biopsy in Solid Pancreatic Lesions; Comparison With 22-gauge Procore Needle
- ClinicalTrials.gov ID
- NCT02920944
- Acronym / sponsor ID
- EUS 20 gauge
- Conditions
- Pancreatic Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Seung Bae YoonUniversity, hospital or other
- Collaborators
- Seoul St. Mary's Hospital
- Study start
- Jul 2016
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 30 Sep 2016 (estimated)
- 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.
This study aims to examine technical feasibility and diagnostic yield of new 20-gauge Procore needle for EUS-guided fine needle biopsy in solid lesions by comparing with 22-gauge Procore needle. The study design is prospective, randomized study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS-FNB with 20-gauge | Experimental | Device: EUS-FNB with 20 gauge ProCore needleEUS-FNB with 20-gauge procore needle |
| EUS-FNB with 22-gauge | Active comparator | Device: EUS-FNB with 22 gauge ProCore needleEUS-FNB with 22-gauge procore needle |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients older than 20 years referred to our medical center for EUS-FNB with diagnosed or suspected solid pancreatic masses according to clinical evaluation and imaging studies.
Key exclusion criteria (1 listed)
- cystic pancreatic lesions, patients haemodynamically unstable or with severe coagulopathy (international normalized ratio [INR] > 1.5 or platelet count < 50,000 cells/cubic millimeter [cmm3]), patients unable to suspend anticoagulant/anti-platelet therapy, pregnancy, inability or refusal to give informed consent, and refusal to participate in the study.
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 |
|---|---|---|
| EUS-FNB with 20 gauge ProCore needleEUS-FNB with 20-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland) | Device | EUS-FNB with 20-gauge |
| EUS-FNB with 22 gauge ProCore needleEUS-FNB with 22-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland) | Device | EUS-FNB with 22-gauge |
Primary outcome
single diagnostic yield of the histologic core
Time frame: up to 5 minutes after endoscopic ultrasound-guided fine needle biopsy
1 secondary outcome
total diagnostic yield of the histologic core
Time frame: up to 5 minutes after endoscopic ultrasound-guided fine needle biopsy
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 3 Oct 2017.
- Individual participant dataSharing planned: Undecided
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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.
In Seok Lee, MD study director
The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-FNB with 20 gauge ProCore needle and EUS-FNB with 22 gauge ProCore needle in people with Pancreatic Neoplasms, run by Seung Bae Yoon at 1 site in South Korea.
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 1 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 3 Oct 2017. 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 South Korea. 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?
single diagnostic yield of the histologic core (time frame: up to 5 minutes after endoscopic ultrasound-guided fine needle biopsy). 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 3 Oct 2017; AzTrials last refreshed its copy on 6 Nov 2026.