Pancreatic MassesNCT02946840
The Use of a New Core Needle in the Endoscopic Ultrasound Assisted Tissue Sampling for Pancreatic Solid Masses
An observational study of Pancreatic Masses, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA) is a reliable, safe, and effective technique for obtaining samples from pancreatic masses. A new core biopsy needle has been developed by Beacon bnx® (Medtronic, Newton, MA) that allows the possibility to achieve a core for histology evaluation and… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pancreatic Masses
- What is being tested?
- FNA with 25 G Beacon needle
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2016to May 2018
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients referred for EUS examination and FNA of solid pancreatic masses, will undergo EUS-FNA with the 25G Shark core needle.
Who may be able to join
- Age greater than 18 and less than 90, both genders..
- Presence of a pancreatic solid lesion. In the presence of a cystic component, the solid part of the lesion should be more 75% of the total.
- Absence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma or coagulation factors.
- Informed consent is obtained.
Who cannot join
- Previous biopsy of the lesion with diagnosis of malignancy
- Presence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma.
- Pregnancy or breast-feeding.
- Patients unable to understand and/or read the consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA) is a reliable, safe, and effective technique for obtaining samples from pancreatic masses. A new core biopsy needle has been developed by Beacon bnx® (Medtronic, Newton, MA) that allows the possibility to achieve a core for histology evaluation and the interchangibility of needle size using the same needle shelter and different needle sizes.
Read the detailed description
At every pass, the material will be fixed in formalin. Three passes will be done. Details of the aspirated material will be described at macroscopic evaluation by the endoscopist and then by the pathologist at macroscopic and microscopic evaluation, in order to find an interobserved agreement on the definition of the core.
- Conditions
- Pancreatic Masses
- Being tested
- FNA with 25 G Beacon needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FNA with 25 G Beacon needleDevice
| Study group | Role | What they receive |
|---|---|---|
| Solid pancreatic masses | Consecutive patients with solid pancreatic masses, submitted to FNA with 25 G Beacon needle (Medtronic, Newton, MA, USA) Receives: Device: FNA with 25 G Beacon needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core acquisition
The presence of a core adequate for histological evaluation for final diagnosis
Measured: 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study startAug 2016
- Primary completionMay 2017
- Study completionMay 2018
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 Pancreatic MassesStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Collaborators
- Maggiore Bellaria Hospital, Bologna, Catholic University of the Sacred Heart, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies, Azienda Ospedaliera Universitaria Integrata Verona, Azienda Unità Sanitaria Locale di Imola
- Responsible party
- Sponsor
- Investigators
- Alessandro Repici, MD, Study director, Humanitas UniversitySilvia Carrara, MD, Principal investigator, Humanitas Research Hospital IRCCS, Rozzano-MilanAlberto Larghi, MD, Study director, Università Cattolica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946840
- Sponsor's protocol ID
- Studio 1587
- Status last verified
- Aug 2018
- First submitted
- 3 Aug 2016
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Di Leo M, Crino SF, Bernardoni L, Rahal D, Auriemma F, Correale L, Donato G, Massidda M, Anderloni A, Manfrin E, Armellini E, Poliani L, Fugazza A, Semeraro R, Occhipinti P, Repici A, Carrara S. EUS-guided core biopsies of pancreatic solid masses using a new fork-tip needle: A multicenter prospective study. Dig Liver Dis. 2019 Sep;51(9):1275-1280. doi: 10.1016/j.dld.2019.03.025. Epub 2019 Apr 20.
PubMed 31010744
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a New Core Needle in the Endoscopic Ultrasound Assisted Tissue Sampling for Pancreatic Solid Masses
- ClinicalTrials.gov ID
- NCT02946840
- Acronym / sponsor ID
- Studio 1587
- Conditions
- Pancreatic Masses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Collaborators
- Maggiore Bellaria Hospital, Bologna, Catholic University of the Sacred Heart, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies, Azienda Ospedaliera Universitaria Integrata Verona, Azienda Unità Sanitaria Locale di Imola
- Study start
- Aug 2016
- Primary completion
- May 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 27 Oct 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.
Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA) is a reliable, safe, and effective technique for obtaining samples from pancreatic masses. A new core biopsy needle has been developed by Beacon bnx® (Medtronic, Newton, MA) that allows the possibility to achieve a core for histology evaluation and the interchangibility of needle size using the same needle shelter and different needle sizes.
Detailed description
At every pass, the material will be fixed in formalin. Three passes will be done. Details of the aspirated material will be described at macroscopic evaluation by the endoscopist and then by the pathologist at macroscopic and microscopic evaluation, in order to find an interobserved agreement on the definition of the core.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Solid pancreatic masses | – | Device: FNA with 25 G Beacon needleConsecutive patients with solid pancreatic masses, submitted to FNA with 25 G Beacon needle (Medtronic, Newton, MA, USA) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients referred for EUS examination and FNA of solid pancreatic masses, will undergo EUS-FNA with the 25G Shark core needle.
Key inclusion criteria (4 listed)
- Age greater than 18 and less than 90, both genders..
- Presence of a pancreatic solid lesion. In the presence of a cystic component, the solid part of the lesion should be more 75% of the total.
- Absence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma or coagulation factors.
- Informed consent is obtained.
Key exclusion criteria (4 listed)
- Previous biopsy of the lesion with diagnosis of malignancy
- Presence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma.
- Pregnancy or breast-feeding.
- Patients unable to understand and/or read the consent form.
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 |
|---|---|---|
| FNA with 25 G Beacon needle | Device | Solid pancreatic masses |
Primary outcome
Core acquisition
Time frame: 24 h
The presence of a core adequate for histological evaluation for final diagnosis
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 8 Aug 2018.
- Derived from this study: PubMed 31010744Di Leo M, Crino SF, Bernardoni L, Rahal D, Auriemma F, Correale L, Donato G, Massidda M, Anderloni A, Manfrin E, Armellini E, Poliani L, Fugazza A, Semeraro R, Occhipinti P, Repici A, Carrara S. EUS-guided core biopsies of pancreatic solid masses using a new fork-tip needle: A multicenter prospective study. Dig Liver Dis. 2019 Sep;51(9):1275-1280. doi: 10.1016/j.dld.2019.03.025. Epub 2019 Apr 20.
- Individual participant dataSharing planned: No
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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.
Alessandro Repici, MD study director
Humanitas University
Silvia Carrara, MD principal investigator
Humanitas Research Hospital IRCCS, Rozzano-Milan
Alberto Larghi, MD study director
Università Cattolica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Masses, run by Istituto Clinico Humanitas at 1 site in Italy.
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 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 8 Aug 2018. 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 Italy. 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?
Core acquisition (time frame: 24 h). 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 NCT02946840, 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 8 Aug 2018.