Pancreatic NeoplasmsNCT01727921
Comparative Study of 22 and 25 Gauge ProCore EUS-guided Biopsy in Pancreatic Mass
A study testing 22 gauge ProCore needle biopsy and 25 gauge ProCore needle biopsy in people with Pancreatic Neoplasms, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Background: EUS-guided fine needle aspiration (FNA) is a major diagnostic tool in the patient with pancreatic mass with high specificity, specificity and accuracy. However FNA with small needle has sometimes failed in acquisition of tissue due to small caliber. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- 22 gauge ProCore needle biopsy and 25 gauge ProCore needle biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2013to Nov 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 years and older
- 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
- Patients who have pancreatic or peripancreatic mass in imaging studies
Who cannot join
- Contraindication to endoscopy
- Patients younger than 18 years old
- Bleeding tendency
- Cardiopulmonary dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Ultrasound-guided Fine Needle Tissue Acquisition With 22- and 25-gauge ProCore Needle in Solid Pancreatic and Peripancreatic Masses: A Prospective Comparative Study
Background:
EUS-guided fine needle aspiration (FNA) is a major diagnostic tool in the patient with pancreatic mass with high specificity, specificity and accuracy. However FNA with small needle has sometimes failed in acquisition of tissue due to small caliber. To overcome this limitation, newly designed ProCore needle was developed and flexible 22 and 25 gauge ProCore needles were frequently used. However there was no comparative study of the efficacy and accuracy between 22 and 25 gauge ProCore needle yet.
Read more
Aim:
To compare the efficacy and accuracy of EUS-guided FNA between 22 and 25 gauge ProCore needle. (The investigators hypothesized that the accuracy of 25 gauge Procore needle is not inferior to 22 gauge ProCore needle.)
Read the detailed description
Patient and methods:
Patients who have pancreatic or peripancreatic mass in imaging studies which need pathologic confirm. These patients were randomly assigned to 22 gauge or 25 gauge group.
Procedure:
They underwent EUS-guided FNA, 3 times with 10 times of to-and pro movement each.
The number of patients required:
We used confidence intervals (CIs) with a prespecified non-inferiority margin of 10% for the non-inferiority analysis. We concluded non-inferiority of PC25 to PC22 if the lower limit of the 95% CI for the difference (PC25-PC22) was not lower than -10%. It was assumed that the diagnostic accuracy of one pass was 75% and that of three cumulative passes was estimated to be 98.4% in PC22. Based on these assumptions, the calculated sample size was 216 samples with power of 80% and significance level of 5%.
- Conditions
- Pancreatic Neoplasms
- Being tested
- 22 gauge ProCore needle biopsy, 25 gauge ProCore needle biopsy
- Keywords
- ProCore FNA biopsy
- 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 biopsyDevice
22 gauge, EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle
25 gauge ProCore needle biopsyDevice
25 gauge, EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle
| Study group | Role | What they receive |
|---|---|---|
| 22 gauge ProCore needle biopsy | Active comparator | EUS-guided pancreatic or peripancreatic mass biopsy with 22 gauge ProCore biopsy needle. Receives: Device: 22 gauge ProCore needle biopsy |
| 25 gauge ProCore needle biopsy | Active comparator | EUS-guided pancreatic or peripancreatic mass biopsy with 25 gauge ProCore biopsy needle. Receives: Device: 25 gauge ProCore needle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
Diagnostic accuracy include histologic diAgnosis and cytologic diagnosis
Measured: October. 2014
Secondary outcomes (1)
Technical success
Technical success means the gain of tissue or cells through EUS-guided FNA.
Measured: October. 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionDec 2014
- Study completionNov 2015
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.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kwang Hyuck Lee, Samsung Medical Center
- Investigators
- Kwanghyuck Lee, MD, Principal investigator, Assistant Professor of Medicine, Division of Gastroenterology, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727921
- Sponsor's protocol ID
- 2012-08-066-001
- Status last verified
- Apr 2016
- First submitted
- 21 Oct 2012
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound-guided Fine Needle Tissue Acquisition With 22- and 25-gauge ProCore Needle in Solid Pancreatic and Peripancreatic Masses: A Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT01727921
- Acronym / sponsor ID
- 2012-08-066-001
- Conditions
- Pancreatic Neoplasms
- Keywords
- ProCore FNA biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 16 Nov 2012 (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:
EUS-guided fine needle aspiration (FNA) is a major diagnostic tool in the patient with pancreatic mass with high specificity, specificity and accuracy. However FNA with small needle has sometimes failed in acquisition of tissue due to small caliber. To overcome this limitation, newly designed ProCore needle was developed and flexible 22 and 25 gauge ProCore needles were frequently used. However there was no comparative study of the efficacy and accuracy between 22 and 25 gauge ProCore needle yet.
Aim:
To compare the efficacy and accuracy of EUS-guided FNA between 22 and 25 gauge ProCore needle. (The investigators hypothesized that the accuracy of 25 gauge Procore needle is not inferior to 22 gauge ProCore needle.)
Detailed description
Patient and methods:
Patients who have pancreatic or peripancreatic mass in imaging studies which need pathologic confirm. These patients were randomly assigned to 22 gauge or 25 gauge group.
Procedure:
They underwent EUS-guided FNA, 3 times with 10 times of to-and pro movement each.
The number of patients required:
We used confidence intervals (CIs) with a prespecified non-inferiority margin of 10% for the non-inferiority analysis. We concluded non-inferiority of PC25 to PC22 if the lower limit of the 95% CI for the difference (PC25-PC22) was not lower than -10%. It was assumed that the diagnostic accuracy of one pass was 75% and that of three cumulative passes was estimated to be 98.4% in PC22. Based on these assumptions, the calculated sample size was 216 samples with power of 80% and significance level of 5%.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 22 gauge ProCore needle biopsy | Active comparator | Device: 22 gauge ProCore needle biopsyEUS-guided pancreatic or peripancreatic mass biopsy with 22 gauge ProCore biopsy needle. |
| 25 gauge ProCore needle biopsy | Active comparator | Device: 25 gauge ProCore needle biopsyEUS-guided pancreatic or peripancreatic mass biopsy with 25 gauge ProCore biopsy needle. |
Who may qualify
- Ages
- 18 years and older
- 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
- Patients who have pancreatic or peripancreatic mass in imaging studies
Key exclusion criteria (4 listed)
- Contraindication to endoscopy
- Patients younger than 18 years old
- Bleeding tendency
- Cardiopulmonary dysfunction
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 biopsy22 gauge, EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle | Device | 22 gauge ProCore needle biopsy |
| 25 gauge ProCore needle biopsy25 gauge, EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle | Device | 25 gauge ProCore needle biopsy |
Primary outcome
Diagnostic accuracy
Time frame: October. 2014
Diagnostic accuracy include histologic diAgnosis and cytologic diagnosis
1 secondary outcome
Technical success
Time frame: October. 2014
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 28 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.
Kwanghyuck Lee, MD principal investigator
Assistant Professor of Medicine, Division of Gastroenterology, 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 biopsy and 25 gauge ProCore needle biopsy in people with Pancreatic Neoplasms, 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 4 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 28 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?
Diagnostic accuracy (time frame: October. 2014). 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 28 Apr 2016.