Solid Pancreatic MassesNCT01795066
Endoscopic Ultrasound-guided Fine Needle Biopsy With 25-gauge Biopsy Needles for Solid Pancreatic Masses
A study testing EUS-FNB with 25-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland) in people with Solid Pancreatic Masses, run by Yonsei University at 1 site in South Korea.
Trial summary
For 12 months after approvement by the University of Yonsei institutional review board, of the 59 patients older than 20 years referred to our medical center for EUS-FNA or FNB, all consecutive pancreatic lesions were evaluated for inclusion in our prospective study. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Solid Pancreatic Masses
- What is being tested?
- EUS-FNB with 25-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2013to 22 Jan 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 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-FNA or 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.
South Korea1 site
Division of Gastroenterology, Department of Internal Medicine, Yonsei Institute of Gastroenterology, Yonsei University College of Medicine
Seoul, 120-752
About this study
For 12 months after approvement by the University of Yonsei institutional review board, of the 59 patients older than 20 years referred to our medical center for EUS-FNA or FNB, all consecutive pancreatic lesions were evaluated for inclusion in our prospective study. The inclusion criteria for this study were the following: diagnosed or suspected solid pancreatic masses according to clinical evaluation and imaging studies with need of histologic tissue confirmation by EUS-FNA or EUS-FNB. The exclusion criteria were the following: 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. Patients undergoing anticoagulant or anti- platelet therapy for non-critical problems discontinued treatment at least 5 days before the endoscopic procedure. Written informed consent was obtained from all patients for the procedures performed and participation in the study, and the study protocol was approved by the University of Yonsei institutional review board. All patients were underwent the procedure under conscious sedation with propofol and midazolam according to the current guidelines.8 After procedure, the patients were monitored for at least six hours in order to immediately detect post-procedural complications and were followed for up to 7 days in order to detect late complications.
- Conditions
- Solid Pancreatic Masses
- Being tested
- EUS-FNB with 25-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-FNB with 25-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)Device
Also called EUS-FNA with the use of Wilson-Cook procore 25-gauge needles (Echotip, Wilson-Cook, Winston Salem, NC, USA)
| Study group | Role | What they receive |
|---|---|---|
| EUS-FNB with 25-gauge | Experimental | Not described Receives: Device: EUS-FNB with 25-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland) |
What is being measured
The primary outcome is the main question the study is designed to answer.
accessing the rate for procurement of the histologic core
The tissue samples were immediately fixed in formalin. The histologic cassette was processed, embedded in paraffin, and then prepared in hematoxylin and eosin to be evaluated by one pathologist (K.H.K) for the presence of a histologic core. If the histologic core was present, the specimen was graded as optimal or suboptimal. Optimal specimens were those in which the procured material enabled satisfactory assessment of histologic architecture that either did not change the original diagnosis or yielded additional findings. Suboptimal specimens were those in which the quality of the histologic core was unsatisfactory for assessment of histologic architecture. When required, immunohistochemical or special staining was performed for differentiation of morphologically challenging lesions.10
Measured: up to 5 minuites after endoscopic ultrasound-guided fine needle biopsy
Secondary outcomes (1)
the percentage of cases in which pathologists classified the sample quality as optimal for histological evaluation of 25-gauge biopsy needle
The tissue samples were immediately fixed in formalin. The histologic cassette was processed, embedded in paraffin, and then prepared in hematoxylin and eosin to be evaluated by one pathologist (K.H.K) for the presence of a histologic core. If the histologic core was present, the specimen was graded as optimal or suboptimal. Optimal specimens were those in which the procured material enabled satisfactory assessment of histologic architecture that either did not change the original diagnosis or yielded additional findings. Suboptimal specimens were those in which the quality of the histologic core was unsatisfactory for assessment of histologic architecture. When required, immunohistochemical or special staining was performed for differentiation of morphologically challenging lesions.10
Measured: up to 5 minuites after 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 posted20 Feb 2013 (estimated)
- Study startJan 2013
- Primary completion22 Jan 2015
- Study completion22 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid Pancreatic MassesStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795066
- Sponsor's protocol ID
- 4-2012-0856
- Status last verified
- Dec 2015
- First submitted
- 12 Feb 2013
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Park SW, Chung MJ, Lee SH, Lee HS, Lee HJ, Park JY, Park SW, Song SY, Kim H, Chung JB, Bang S. Prospective Study for Comparison of Endoscopic Ultrasound-Guided Tissue Acquisition Using 25- and 22-Gauge Core Biopsy Needles in Solid Pancreatic Masses. PLoS One. 2016 May 5;11(5):e0154401. doi: 10.1371/journal.pone.0154401. eCollection 2016.
PubMed 27149404
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound-guided Fine Needle Biopsy With 25-gauge Biopsy Needles for Solid Pancreatic Masses
- ClinicalTrials.gov ID
- NCT01795066
- Acronym / sponsor ID
- 4-2012-0856
- Conditions
- Solid Pancreatic Masses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- 22 Jan 2015 (actual)
- Study completion
- 22 Jan 2015 (actual)
- First posted
- 20 Feb 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.
For 12 months after approvement by the University of Yonsei institutional review board, of the 59 patients older than 20 years referred to our medical center for EUS-FNA or FNB, all consecutive pancreatic lesions were evaluated for inclusion in our prospective study. The inclusion criteria for this study were the following: diagnosed or suspected solid pancreatic masses according to clinical evaluation and imaging studies with need of histologic tissue confirmation by EUS-FNA or EUS-FNB. The exclusion criteria were the following: 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. Patients undergoing anticoagulant or anti- platelet therapy for non-critical problems discontinued treatment at least 5 days before the endoscopic procedure. Written informed consent was obtained from all patients for the procedures performed and participation in the study, and the study protocol was approved by the University of Yonsei institutional review board. All patients were underwent the procedure under conscious sedation with propofol and midazolam according to the current guidelines.8 After procedure, the patients were monitored for at least six hours in order to immediately detect post-procedural complications and were followed for up to 7 days in order to detect late complications.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EUS-FNB with 25-gauge | Experimental | Device: EUS-FNB with 25-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland) |
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-FNA or 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 25-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)Also: EUS-FNA with the use of Wilson-Cook procore 25-gauge needles (Echotip, Wilson-Cook, Winston Salem, NC, USA) | Device | EUS-FNB with 25-gauge |
Primary outcome
accessing the rate for procurement of the histologic core
Time frame: up to 5 minuites after endoscopic ultrasound-guided fine needle biopsy
The tissue samples were immediately fixed in formalin. The histologic cassette was processed, embedded in paraffin, and then prepared in hematoxylin and eosin to be evaluated by one pathologist (K.H.K) for the presence of a histologic core. If the histologic core was present, the specimen was graded as optimal or suboptimal. Optimal specimens were those in which the procured material enabled satisfactory assessment of histologic architecture that either did not change the original diagnosis or yielded additional findings. Suboptimal specimens were those in which the quality of the histologic core was unsatisfactory for assessment of histologic architecture. When required, immunohistochemical or special staining was performed for differentiation of morphologically challenging lesions.10
1 secondary outcome
the percentage of cases in which pathologists classified the sample quality as optimal for histological evaluation of 25-gauge biopsy needle
Time frame: up to 5 minuites after 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 29 Mar 2019.
- Derived from this study: PubMed 27149404Park SW, Chung MJ, Lee SH, Lee HS, Lee HJ, Park JY, Park SW, Song SY, Kim H, Chung JB, Bang S. Prospective Study for Comparison of Endoscopic Ultrasound-Guided Tissue Acquisition Using 25- and 22-Gauge Core Biopsy Needles in Solid Pancreatic Masses. PLoS One. 2016 May 5;11(5):e0154401. doi: 10.1371/journal.pone.0154401. eCollection 2016.
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Pancreatic Masses
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.
The record lists no contact. Use the official record to reach the sponsor.
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 25-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland) in people with Solid Pancreatic Masses, run by Yonsei University 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 29 Mar 2019. 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?
accessing the rate for procurement of the histologic core (time frame: up to 5 minuites 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?
On the ClinicalTrials.gov record for NCT01795066, which also lists 1 linked publication.
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 29 Mar 2019.