Pancreatic CancerNCT01876069
Comparing Newly Developed PreCore Needle With Conventional Fine Needle in Suspected Unresectable Pancreatic Cancer
A study testing 22 gauge ProCore needle aspiration and 22 gauge Fine needle aspiration in people with Pancreatic Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Background: Pancreatic cancer is associated with a poor prognosis. Therefore, rapid and accurate diagnosis of a pancreatic mass is important to direct patient management. Endoscopic ultrasonography-guided fine needle aspiration (EUS-FNA) is the current standard for sampling pancreatic mass lesions, with diagnostic… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- 22 gauge ProCore needle aspiration and 22 gauge Fine needle aspiration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2013to Feb 2015
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who agree to participate in research
- 18 years of age and older patients less than 80 years old
- Patients who have suspected unresectable pancreatic cancer in imaging studies
Who cannot join
- Contraindication to endoscopy
- Patients younger than 18 years old or older than 80 years old
- Bleeding tendency
- Cardiopulmonary dysfunction
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Newly Developed PreCore Needle With Conventional Fine Needle in Endoscopic Ultrasonography-guided Sampling of Suspected Unresectable Pancreatic Cancer
Background:
Pancreatic cancer is associated with a poor prognosis. Therefore, rapid and accurate diagnosis of a pancreatic mass is important to direct patient management. Endoscopic ultrasonography-guided fine needle aspiration (EUS-FNA) is the current standard for sampling pancreatic mass lesions, with diagnostic accuracy of 78% to 95%. But, the EUS-FNA has some limitations include stromal cell tumors and lymphomas may be difficult to diagnose. To overcome these limitations, a new needle device with ProCore reverse-bevel technology was developed recently.
Read more
Aims:
The objective of this prospective study is to compare the rate of diagnostic sufficiency in the EUS sampling by using newly developed ProCore needle with conventional FNA needle in suspected unresectable pancreatic cancer. We will also compare the safety, the yield of histologic core tissue and the cost-effectiveness between these modalities.
Read the detailed description
Patient:
Newly diagnosed pancreatic cancer patient whose cancer lesion is suspected unresectable in diagnostic imaging such as CT or MRI
Procedure:
Each EUS-guided FNA and ProCore aspiration will performed twice in same patient. The priority of order will be given by randomization assignment.
The number of patients required:
Total sixty five patients will be required.
- Conditions
- Pancreatic Cancer
- Being tested
- 22 gauge ProCore needle aspiration, 22 gauge Fine needle aspiration
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
22 gauge ProCore needle aspirationDevice
Also called EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle
Pancreatic mass evaluation through the 22 gauge ProCore needle aspiration
22 gauge Fine needle aspirationDevice
Also called 22 gauge, EN-SHOT2 Side Port Aspiration Needle
Pancreatic mass evaluation through the 22 gauge Fine needle aspiration
| Study group | Role | What they receive |
|---|---|---|
| 22 gauge ProCore needle aspiration | Active comparator | EUS-guided pancreatic mass aspiration with 22 gauge ProCore needle Receives: Device: 22 gauge ProCore needle aspiration |
| 22 gauge Fine needle aspiration | Active comparator | EUS-guided pancreatic mass aspiration with 22 gauge Fine needle Receives: Device: 22 gauge Fine needle aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rates of diagnostic sufficiency
The rates of diagnostic sufficency will be assessed by the pathologist as the proportion of definate diagnosis from cytology and histology within 2 passes of each procendure
Measured: Up to 1 year
Secondary outcomes (1)
The presence of histologic core
The presence histologic core means the gain of tissue, not clustered cells, through each procedure. It will be also assessed by the pathologist.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Olympus
- Responsible party
- Principal investigator, Kwang Hyuck Lee, Samsung Medical Center
- Investigators
- Kwang Hyuck Lee, MD., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876069
- Sponsor's protocol ID
- 2013-02-018
- Status last verified
- Apr 2016
- First submitted
- 4 Jun 2013
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Newly Developed PreCore Needle With Conventional Fine Needle in Endoscopic Ultrasonography-guided Sampling of Suspected Unresectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01876069
- Acronym / sponsor ID
- 2013-02-018
- Conditions
- Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Olympus
- Study start
- Jul 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 12 Jun 2013 (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.
Background:
Pancreatic cancer is associated with a poor prognosis. Therefore, rapid and accurate diagnosis of a pancreatic mass is important to direct patient management. Endoscopic ultrasonography-guided fine needle aspiration (EUS-FNA) is the current standard for sampling pancreatic mass lesions, with diagnostic accuracy of 78% to 95%. But, the EUS-FNA has some limitations include stromal cell tumors and lymphomas may be difficult to diagnose. To overcome these limitations, a new needle device with ProCore reverse-bevel technology was developed recently.
Aims:
The objective of this prospective study is to compare the rate of diagnostic sufficiency in the EUS sampling by using newly developed ProCore needle with conventional FNA needle in suspected unresectable pancreatic cancer. We will also compare the safety, the yield of histologic core tissue and the cost-effectiveness between these modalities.
Detailed description
Patient:
Newly diagnosed pancreatic cancer patient whose cancer lesion is suspected unresectable in diagnostic imaging such as CT or MRI
Procedure:
Each EUS-guided FNA and ProCore aspiration will performed twice in same patient. The priority of order will be given by randomization assignment.
The number of patients required:
Total sixty five patients will be required.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 22 gauge ProCore needle aspiration | Active comparator | Device: 22 gauge ProCore needle aspirationEUS-guided pancreatic mass aspiration with 22 gauge ProCore needle |
| 22 gauge Fine needle aspiration | Active comparator | Device: 22 gauge Fine needle aspirationEUS-guided pancreatic mass aspiration with 22 gauge Fine needle |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who agree to participate in research
- 18 years of age and older patients less than 80 years old
- Patients who have suspected unresectable pancreatic cancer in imaging studies
Key exclusion criteria (5 listed)
- Contraindication to endoscopy
- Patients younger than 18 years old or older than 80 years old
- Bleeding tendency
- Cardiopulmonary dysfunction
- 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 |
|---|---|---|
| 22 gauge ProCore needle aspirationAlso: EchoTip® ProCore™ High Definition Ultrasound Biopsy NeedlePancreatic mass evaluation through the 22 gauge ProCore needle aspiration | Device | 22 gauge ProCore needle aspiration |
| 22 gauge Fine needle aspirationAlso: 22 gauge, EN-SHOT2 Side Port Aspiration NeedlePancreatic mass evaluation through the 22 gauge Fine needle aspiration | Device | 22 gauge Fine needle aspiration |
Primary outcome
The rates of diagnostic sufficiency
Time frame: Up to 1 year
The rates of diagnostic sufficency will be assessed by the pathologist as the proportion of definate diagnosis from cytology and histology within 2 passes of each procendure
1 secondary outcome
The presence of histologic core
Time frame: Up to 1 year
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 Apr 2016.
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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.
Kwang Hyuck Lee, MD. principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 22 gauge ProCore needle aspiration and 22 gauge Fine needle aspiration in people with Pancreatic Cancer, run by Samsung Medical Center 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 3 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 27 Apr 2016. 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?
The rates of diagnostic sufficiency (time frame: Up to 1 year). 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 Apr 2016; AzTrials last refreshed its copy on 31 Oct 2026.