Pancreatic CancerEUS-FNANCT02246322
A Clinical Trial With a New Needle Device Comparing Two Needles for EUS_FNA of Solid Lesions.
A study testing 25G needle and 22G needle in people with Pancreatic Cancer and Neuroendocrine Tumors, 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 the GI wall lesions and from organs adjacent to the GI tract (pancreas, nodes...).Needles available for EUS-FNA include 25G, 22G and 19G. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Neuroendocrine Tumors, Lymphadenopathies
- What is being tested?
- 25G needle and 22G needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2013to Nov 2014
- 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
- endosonographic appearance of a solid lesions
- age >18 years
- informed consent.
Who cannot join
- alteration of the coagulation (INR >1.5, PLT <50 x 103 /µL)
- inability to express consent
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Humanitas Research Hospital
Rozzano, Milan, 20089
Alessandro Repici, MD, +390282247493, alessadro.repici@humanitas.it
Silvia Carrara, MD
About this study
Official title: A Randomized Clinical Trial With a New Needle Device Comparing 25G and 22G Needle in Endoscopic Ultrasound Fine-needle Aspiration of Solid Lesions.
Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA) is a reliable, safe, and effective technique for obtaining samples from the GI wall lesions and from organs adjacent to the GI tract (pancreas, nodes...).Needles available for EUS-FNA include 25G, 22G and 19G. Some studies have suggested that the 25G needle could be equal or even better than the 22G needle.
The BXN system and neddles are is a newly developed for EUS-FNA. This trial is developed for testing the accuracy of the new neddle system for EUS-FNA and for comparing the two needles types, 25G and 22G.
- Being tested
- 25G needle, 22G needle
- Keywords
- Pancreatic cancer, Neuroendocrine tumors, Lymphadenopathies, GIST, Gastrointestinal wall neoplasia
- Medical subject headings
- Pancreatic Neoplasms, Neuroendocrine Tumors, Lymphadenopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25G needleDevice
All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B).
22G needleDevice
All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B).
| Study group | Role | What they receive |
|---|---|---|
| 25G needle | Experimental | All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B). Receives: Device: 25G needle |
| 22G needle | Experimental | All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B). Receives: Device: 22G needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance of 22G and 25G needles
Evaluation of whether enough material for adequate cytological/histological analysis can obtained with equal efficacy with the 25G and the 22G needles. The percentages of adequate samples obtained.
Measured: 18 months
Secondary outcomes (5)
Ease of needle pass
The subjective evaluation of the operator (easy or hard)
Measured: 18 months
Needle malfunction
Needles do not come out of the cover; kinking; needles do not puncture the tissue (presence or absence of malfunction, and registering of the specific malfunction)
Measured: 18 months
Number of passes
The total number of passes needed to obtain adequate material for each lesion (absolute number).
Measured: 18 months
Number of crossovers
The times when the need for passage from the 22G to the 25G needle, or vice versa, registered as percentages of the total procedures.
Measured: 18 months
Major complications
Bleeding (minor: visible at EUS but without clinical significance or less than 2 g/dl; major: dropping of more than 2 g/dl in Hb levels and clinically significant), perforation (presence/absence), infection (need for hospitalization).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study startAug 2013
- Primary completionOct 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies 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
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Tedeschi, Istituto Clinico Humanitas
- Investigators
- Silvia Carrara, MD, Principal investigator, Humanitas Research Hospital IRCCS, Rozzano-Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246322
- Sponsor's protocol ID
- BNX-1
- Acronym
- EUS-FNA
- Status last verified
- Sep 2014
- First submitted
- 1 Sep 2014
- Last updated
- 22 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Camellini L, Carlinfante G, Azzolini F, Iori V, Cavina M, Sereni G, Decembrino F, Gallo C, Tamagnini I, Valli R, Piana S, Campari C, Gardini G, Sassatelli R. A randomized clinical trial comparing 22G and 25G needles in endoscopic ultrasound-guided fine-needle aspiration of solid lesions. Endoscopy. 2011 Aug;43(8):709-15. doi: 10.1055/s-0030-1256482. Epub 2011 May 24.
PubMed 21611946Siddiqui UD, Rossi F, Rosenthal LS, Padda MS, Murali-Dharan V, Aslanian HR. EUS-guided FNA of solid pancreatic masses: a prospective, randomized trial comparing 22-gauge and 25-gauge needles. Gastrointest Endosc. 2009 Dec;70(6):1093-7. doi: 10.1016/j.gie.2009.05.037. Epub 2009 Jul 28.
PubMed 19640524
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial With a New Needle Device Comparing 25G and 22G Needle in Endoscopic Ultrasound Fine-needle Aspiration of Solid Lesions.
- ClinicalTrials.gov ID
- NCT02246322
- Acronym / sponsor ID
- EUS-FNA / BNX-1
- Keywords
- Pancreatic cancer, Neuroendocrine tumors, Lymphadenopathies, GIST, Gastrointestinal wall neoplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 22 Sep 2014 (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 the GI wall lesions and from organs adjacent to the GI tract (pancreas, nodes...).Needles available for EUS-FNA include 25G, 22G and 19G. Some studies have suggested that the 25G needle could be equal or even better than the 22G needle.
The BXN system and neddles are is a newly developed for EUS-FNA. This trial is developed for testing the accuracy of the new neddle system for EUS-FNA and for comparing the two needles types, 25G and 22G.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 25G needle | Experimental | Device: 25G needleAll consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B). |
| 22G needle | Experimental | Device: 22G needleAll consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- endosonographic appearance of a solid lesions
- age >18 years
- informed consent.
Key exclusion criteria (2 listed)
- alteration of the coagulation (INR >1.5, PLT <50 x 103 /µL)
- inability to express consent
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 |
|---|---|---|
| 25G needleAll consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B). | Device | 25G needle |
| 22G needleAll consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B). | Device | 22G needle |
Primary outcome
Clinical performance of 22G and 25G needles
Time frame: 18 months
Evaluation of whether enough material for adequate cytological/histological analysis can obtained with equal efficacy with the 25G and the 22G needles. The percentages of adequate samples obtained.
5 secondary outcomes
Ease of needle pass
Time frame: 18 months
Needle malfunction
Time frame: 18 months
Number of passes
Time frame: 18 months
Number of crossovers
Time frame: 18 months
Major complications
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2014.
- Background: PubMed 21611946Camellini L, Carlinfante G, Azzolini F, Iori V, Cavina M, Sereni G, Decembrino F, Gallo C, Tamagnini I, Valli R, Piana S, Campari C, Gardini G, Sassatelli R. A randomized clinical trial comparing 22G and 25G needles in endoscopic ultrasound-guided fine-needle aspiration of solid lesions. Endoscopy. 2011 Aug;43(8):709-15. doi: 10.1055/s-0030-1256482. Epub 2011 May 24.
- Background: PubMed 19640524Siddiqui UD, Rossi F, Rosenthal LS, Padda MS, Murali-Dharan V, Aslanian HR. EUS-guided FNA of solid pancreatic masses: a prospective, randomized trial comparing 22-gauge and 25-gauge needles. Gastrointest Endosc. 2009 Dec;70(6):1093-7. doi: 10.1016/j.gie.2009.05.037. Epub 2009 Jul 28.
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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.
Silvia Carrara, MD principal investigator
Humanitas Research Hospital IRCCS, Rozzano-Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 25G needle and 22G needle in people with Pancreatic Cancer and Neuroendocrine Tumors, 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Sep 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvia Carrara, MD (+390282247288, silvia.carrara@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical performance of 22G and 25G needles (time frame: 18 months). 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 NCT02246322, which also lists 2 linked publications.
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 22 Sep 2014.