EUS Guided BiopsyNCT03672032
SharkCore Versus Acquire FNB
A study testing Fork-tip Needle and Franseen Needle in people with EUS Guided Biopsy, run by Henning Gerke at 1 site in United States.
Trial summary
Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) has been established as an effective technique for sampling tissue inside and around the gastrointestinal tract, including the pancreas, liver, lymph nodes, and adrenal glands. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- EUS Guided Biopsy
- What is being tested?
- Fork-tip Needle and Franseen Needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients schedule for EUS guided biopsy
Who cannot join
- Patients who had EUS-FNA for cystic fluid aspiration
- Pregnant females
- International normalized ratio >1.5 and platelet count < 50,000
- Medically unstable
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52402
About this study
Official title: Randomized Controlled Trial Comparing the Franseen Needle With a Fork-tip Needle for EUS-guided Fine Needle Biopsy
Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) has been established as an effective technique for sampling tissue inside and around the gastrointestinal tract, including the pancreas, liver, lymph nodes, and adrenal glands. EUS-FNA is convenient, minimally invasive, and safe procedure with an estimated sensitivity of 75%-92% and a specificity of 82%-100%.
Diagnosis of various pathologies in the GI tract including solid pancreatic masses, mediastinal or gastric lymph nodes, gastrointestinal submucosal lesions, and peri-rectal lesions require adequate tissue architecture and immunohistochemical analysis. This is difficult to obtain and is frequently insufficient with EUS-FNA cytology alone. The core tissue is required to improve the diagnostic yield and obtain histologic diagnosis along with immunostaining to establish specimen adequacy. In past 1 year two new needle EUS needle (Shark Core)and Acquire EUS needles has been introduced to improve diagnostic accuracy, tissue yield, and potentially obtain a core tissue sample. So far, no prospective studies have compared these two needles to see which one is better for overall diagnostic accuracy. Our goal is to perform a prospective analysis to compare the diagnostic yield and safety profile of these 2 new EUS needle.
Read the detailed description
Subjects will come to a pre-procedure room on the day of the procedure. The investigator will again go over the risk and benefit of procedure and indication of the procedure. Once the consent form is signed, a large bore IV cannula is placed and the subject will be taken to the DHC procedure room. Once all the team members required to perform the procedure are in the room we will do a time-out to make sure current patient and procedure are performed. A time-out is done by asking the subject to tell his full name with date of birth and describe in his own words what procedure is planned for subject today. If all the things match the investigator will go ahead and start the sedation.
All EUS-FNB will be performed in the standard manner using linear echoendoscopes. All EUS-FNB procedures were performed by 1 of 2 highly experienced endosonographers (Henning Gerke or Rami EL-Abiad).
The needle to be used (SharkCore vs Acquire) will be decided based on randomization software. The needle will then be used to puncture the target lesion in standard fashion. Aspirated cellular materials will be expressed into the slide by advancing the stylet. The remainder will be expressed onto filter paper and submitted for cell block preparation. The subject's medical information including diagnosis, date of diagnosis, date of admission, blood test results, and medications received will be reviewed for analysis.
- Conditions
- EUS Guided Biopsy
- Being tested
- Fork-tip Needle, Franseen Needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fork-tip NeedleDevice
Fork-tip Needle will be used to obtain biopsy
Franseen NeedleDevice
Franseen Needle will be used to obtain biopsy
| Study group | Role | What they receive |
|---|---|---|
| Fork-tip Needle | Active comparator | Not described Receives: Device: Fork-tip Needle |
| Franseen Needle | Active comparator | Not described Receives: Device: Franseen Needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is the Acquire Needle Non-inferior Compared to SharkCore Needle in Histologic Yield of the Sample Obtained?
A pathologist blinded to clinical information will access each Biopsy specimen for adequacy (scoring system where scores of 0 were samples with no material, 1 - sufficient material for adequate histological interpretation, low quality (total material <10x power field in length), 2 - sufficient material for adequate histological interpretation, high quality (>10x power field in length)
Measured: 12 months
Secondary outcomes (2)
Is the Acquire Needle Non-inferior Compared to SharkCore Needle in Diagnostic Accuracy?
The diagnostic accuracy was calculated considering malignant diagnoses as a true positive.
A histological or cytological diagnosis of a neoplastic lesion will be considered correct since false-positive diagnoses have been reported to be rare if strict cytological criteria are applied.
The criterion standard for diagnosis of benign, non-neoplastic lesion that will not undergo surgical resection will be based on a combination of clinal impression, imaging characteristics and a clinical course that was consistent with the study diagnosis.
Measured: 12 months
Is the Acquire Needle Non-inferior Compared to SharkCore Needle in Number of Needle Passes Required to Obtain the Tissue Sample?
We will be collecting data on how many needle passes are required to get adequate FNB sample for each procedure. In the end, we will use this data to calculate using standard statistical measures to compare the average number of passes required to get adequate sample by both SharkCore and Acquire needle.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start29 Oct 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EUS Guided BiopsyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henning Gerke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Henning Gerke, University of Iowa
- Investigators
- Henning Gerke, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03672032
- Sponsor's protocol ID
- 201808820
- Status last verified
- Jun 2021
- First submitted
- 30 Aug 2018
- Last updated
- 13 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We will not be sharing IPD.
Publications
Ashat M, Klair JS, Rooney SL, Vishal SJ, Jensen C, Sahar N, Murali AR, El-Abiad R, Gerke H. Randomized controlled trial comparing the Franseen needle with the Fork-tip needle for EUS-guided fine-needle biopsy. Gastrointest Endosc. 2021 Jan;93(1):140-150.e2. doi: 10.1016/j.gie.2020.05.057. Epub 2020 Jun 9.
PubMed 32526235
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing the Franseen Needle With a Fork-tip Needle for EUS-guided Fine Needle Biopsy
- ClinicalTrials.gov ID
- NCT03672032
- Acronym / sponsor ID
- 201808820
- Conditions
- EUS Guided Biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Henning GerkeUniversity, hospital or other
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 14 Sep 2018 (actual)
- Results
- Posted 13 Jul 2021
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 (EUS-FNA) has been established as an effective technique for sampling tissue inside and around the gastrointestinal tract, including the pancreas, liver, lymph nodes, and adrenal glands. EUS-FNA is convenient, minimally invasive, and safe procedure with an estimated sensitivity of 75%-92% and a specificity of 82%-100%.
Diagnosis of various pathologies in the GI tract including solid pancreatic masses, mediastinal or gastric lymph nodes, gastrointestinal submucosal lesions, and peri-rectal lesions require adequate tissue architecture and immunohistochemical analysis. This is difficult to obtain and is frequently insufficient with EUS-FNA cytology alone. The core tissue is required to improve the diagnostic yield and obtain histologic diagnosis along with immunostaining to establish specimen adequacy. In past 1 year two new needle EUS needle (Shark Core)and Acquire EUS needles has been introduced to improve diagnostic accuracy, tissue yield, and potentially obtain a core tissue sample. So far, no prospective studies have compared these two needles to see which one is better for overall diagnostic accuracy. Our goal is to perform a prospective analysis to compare the diagnostic yield and safety profile of these 2 new EUS needle.
Detailed description
Subjects will come to a pre-procedure room on the day of the procedure. The investigator will again go over the risk and benefit of procedure and indication of the procedure. Once the consent form is signed, a large bore IV cannula is placed and the subject will be taken to the DHC procedure room. Once all the team members required to perform the procedure are in the room we will do a time-out to make sure current patient and procedure are performed. A time-out is done by asking the subject to tell his full name with date of birth and describe in his own words what procedure is planned for subject today. If all the things match the investigator will go ahead and start the sedation.
All EUS-FNB will be performed in the standard manner using linear echoendoscopes. All EUS-FNB procedures were performed by 1 of 2 highly experienced endosonographers (Henning Gerke or Rami EL-Abiad).
The needle to be used (SharkCore vs Acquire) will be decided based on randomization software. The needle will then be used to puncture the target lesion in standard fashion. Aspirated cellular materials will be expressed into the slide by advancing the stylet. The remainder will be expressed onto filter paper and submitted for cell block preparation. The subject's medical information including diagnosis, date of diagnosis, date of admission, blood test results, and medications received will be reviewed for analysis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fork-tip Needle | Active comparator | Device: Fork-tip Needle |
| Franseen Needle | Active comparator | Device: Franseen Needle |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients schedule for EUS guided biopsy
Key exclusion criteria (4 listed)
- Patients who had EUS-FNA for cystic fluid aspiration
- Pregnant females
- International normalized ratio >1.5 and platelet count < 50,000
- Medically unstable
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 |
|---|---|---|
| Fork-tip NeedleFork-tip Needle will be used to obtain biopsy | Device | Fork-tip Needle |
| Franseen NeedleFranseen Needle will be used to obtain biopsy | Device | Franseen Needle |
Primary outcome
Is the Acquire Needle Non-inferior Compared to SharkCore Needle in Histologic Yield of the Sample Obtained?
Time frame: 12 months
A pathologist blinded to clinical information will access each Biopsy specimen for adequacy (scoring system where scores of 0 were samples with no material, 1 - sufficient material for adequate histological interpretation, low quality (total material <10x power field in length), 2 - sufficient material for adequate histological interpretation, high quality (>10x power field in length)
2 secondary outcomes
Is the Acquire Needle Non-inferior Compared to SharkCore Needle in Diagnostic Accuracy?
Time frame: 12 months
Is the Acquire Needle Non-inferior Compared to SharkCore Needle in Number of Needle Passes Required to Obtain the Tissue Sample?
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32526235Ashat M, Klair JS, Rooney SL, Vishal SJ, Jensen C, Sahar N, Murali AR, El-Abiad R, Gerke H. Randomized controlled trial comparing the Franseen needle with the Fork-tip needle for EUS-guided fine-needle biopsy. Gastrointest Endosc. 2021 Jan;93(1):140-150.e2. doi: 10.1016/j.gie.2020.05.057. Epub 2020 Jun 9.
- Individual participant dataSharing planned: No. We will not be sharing IPD.
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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.
Henning Gerke, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fork-tip Needle and Franseen Needle in people with EUS Guided Biopsy, run by Henning Gerke at 1 site in United States.
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 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 13 Jul 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 13 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Is the Acquire Needle Non-inferior Compared to SharkCore Needle in Histologic Yield of the Sample Obtained? (time frame: 12 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 NCT03672032, 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 13 Jul 2021.