Mesenchymal TumorPhase 2NCT02766842
Evaluation of a New EUS Guided Biopsy Needle (SharkCore) Comparing to Standard EUS Needle (ProCore)
A Phase 2 study testing EUS-FNB with ProCore needle, EUS-FNB with SharkCore needle and ProCore needle in people with Mesenchymal Tumor and Autoimmune Pancreatitis, run by Johns Hopkins University at 1 site in United States.
Trial summary
Diagnosis of lesions of pancreas, the upper gastrointestinal tract, as well as adjacent structures, such as lymph nodes, is still showing advancements especially with the increased use of endoscopic ultrasound. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Mesenchymal Tumor, Autoimmune Pancreatitis, Lymphoma
- What is being tested?
- EUS-FNB with ProCore needle, EUS-FNB with SharkCore needle and ProCore needle
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Feb 2017
- Phase
- Phase 2
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years of age referred for EUS
- Lesions requiring histologic diagnosis:
- Mesenchymal tumors
- Autoimmune pancreatitis
- Granulomatous disease
- Indeterminate hepatitis
Show all 10Show fewer
- Confirmatory immunochemistry to establish a diagnosis (i.e. pancreatic neuroendocrine tumor)
- Lymphoma
- Solid tumors
- Previously non-diagnostic FNA
Who cannot join
- Uncorrectable coagulopathy (INR > 1.5)
- Uncorrectable thrombocytopenia (platelet < 50,000)
- Uncooperative patients
- Pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures)
- Refusal to consent form
- Cystic lesions
- Inaccessible lesions to EUS (proximal to sigmoid colon or distal to second duodenum)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a New EUS Guided Biopsy Needle (SharkCore) Comparing to Standard EUS Needle (ProCore): A Prospective Randomized, Controlled Multicenter Study
Diagnosis of lesions of pancreas, the upper gastrointestinal tract, as well as adjacent structures, such as lymph nodes, is still showing advancements especially with the increased use of endoscopic ultrasound. Endoscopic ultrasound-guided fine needle aspiration and fine needle biopsy (EUS-FNA/FNB) have become mainstay diagnostic techniques for these lesions. The purpose of the study is to compare between the currently used, ProCore needles and the new biopsy needle, SharkCore, for the histological diagnosis and evaluation of lesions.
Read the detailed description
Endoscopic ultrasound-guided fine needle aspiration and fine needle biopsy (EUS-FNA/FNB) have become mainstay diagnostic techniques for the diagnosis and evaluation of lesions of the pancreas, the upper gastrointestinal tract, as well as adjacent structures, including lymph nodes. Cytology specimens provided from FNA cannot fully characterize certain neoplasms such as lymphomas or mesenchymal tumors. Core biopsy specimens for histological examinations are needed to provide accurate diagnoses.
ProCore needles (ProCore, Wilson-Cook Medical Inc. Winston-Salem, NC) were designed to obtain histological and cytological samples. Studies comparing ProCore needles with standard FNA needles showed no significant difference in diagnostic accuracy, histological core tissue procurement or mean number of passes.
To overcome the above mentioned limitations (mainly suboptimal core tissue procurement rates), a new novel SharkCore needle (Beacon Endoscopic, Newton, MA, USA) has been designed and approved for clinical human use by the FDA.
The objective of the study is to compare the new EUS guided histology biopsy needle SharkCore to the currently used EUS histology needle, ProCore, for the histological diagnosis and evaluation of lesions.
- Conditions
- Mesenchymal Tumor, Autoimmune Pancreatitis, Lymphoma, Solid Tumors
- Being tested
- EUS-FNB with ProCore needle, EUS-FNB with SharkCore needle, ProCore needle, SharkCore needle
- Keywords
- SharkCore, ProCore
- Medical subject headings
- Autoimmune Pancreatitis, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-FNB with ProCore needleProcedure or surgery
The use of the standard ProCore needle to acquire diagnostic tissue
EUS-FNB with SharkCore needleProcedure or surgery
The use of new SharkCore needle to acquire diagnostic tissue
ProCore needleDevice
This is the standard needle used currently to procure tissue from lesions under endoscopic ultrasound guidance
SharkCore needleDevice
This is the new FDA approved needle for tissue procurement under endoscopic ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| EUS-FNB with ProCore needle | Active comparator | General anesthesia or conscious sedation will be started and an upper endoscopic ultrasound will be inserted into the participants mouth and advanced to the site of the lesion. The lesion will be punctured by the ProCore needle, then the stylet is completely removed, and negative suction pressure is applied using a 10 ml syringe for 30 seconds while the needle is stationary with the target. Then, the needle is moved back and forth several times within the target, utilizing the fanning technique. Finally, suction is released by closing the lock of the syringe and the needle is removed. Receives: Procedure: EUS-FNB with ProCore needle; Device: ProCore needle |
| EUS-FNB with SharkCore needle | Active comparator | The procedure will be done in the same manner with same endoscopic technique and method of tissue procurement. The only difference will be using the SharkCore needle to acquire tissue. Receives: Procedure: EUS-FNB with SharkCore needle; Device: SharkCore needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of needle as assessed by diagnostic yield of needle and final diagnosis method
The final diagnosis of tissue from needle will be compared to the final diagnosis reached either by surgical removal of mass or other method of biopsy
Measured: Up to 1 month
Secondary outcomes (3)
Number of passes to procure core tissue from needle
The number of passes needed to acquire core tissue as assessed by the pathologist in the room.
Measured: During procedure
Safety of tissue procurement by needle
All complications related to needle used will be recorded with a preset questionnaire to measure the frequency of complications related to needle used.
Measured: Up to 1 year
Procedure time
Time required to acquire tissue using each needle will be recorded from time of needle insertion to time of core tissue procurement as per pathologist.
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startApr 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Why it stopped: The reason was the fact that the ProCore needle was removed from clinical use
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesenchymal TumorStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mouen Khashab, Johns Hopkins University
- Investigators
- Mouen Khashab, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766842
- Sponsor's protocol ID
- IRB00095614
- Status last verified
- May 2017
- First submitted
- 6 May 2016
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New EUS Guided Biopsy Needle (SharkCore) Comparing to Standard EUS Needle (ProCore): A Prospective Randomized, Controlled Multicenter Study
- ClinicalTrials.gov ID
- NCT02766842
- Acronym / sponsor ID
- IRB00095614
- Conditions
- Mesenchymal Tumor, Autoimmune Pancreatitis, Lymphoma, Solid Tumors
- Keywords
- SharkCore, ProCore
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The reason was the fact that the ProCore needle was removed from clinical use
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 10 May 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.
Diagnosis of lesions of pancreas, the upper gastrointestinal tract, as well as adjacent structures, such as lymph nodes, is still showing advancements especially with the increased use of endoscopic ultrasound. Endoscopic ultrasound-guided fine needle aspiration and fine needle biopsy (EUS-FNA/FNB) have become mainstay diagnostic techniques for these lesions. The purpose of the study is to compare between the currently used, ProCore needles and the new biopsy needle, SharkCore, for the histological diagnosis and evaluation of lesions.
Detailed description
Endoscopic ultrasound-guided fine needle aspiration and fine needle biopsy (EUS-FNA/FNB) have become mainstay diagnostic techniques for the diagnosis and evaluation of lesions of the pancreas, the upper gastrointestinal tract, as well as adjacent structures, including lymph nodes. Cytology specimens provided from FNA cannot fully characterize certain neoplasms such as lymphomas or mesenchymal tumors. Core biopsy specimens for histological examinations are needed to provide accurate diagnoses.
ProCore needles (ProCore, Wilson-Cook Medical Inc. Winston-Salem, NC) were designed to obtain histological and cytological samples. Studies comparing ProCore needles with standard FNA needles showed no significant difference in diagnostic accuracy, histological core tissue procurement or mean number of passes.
To overcome the above mentioned limitations (mainly suboptimal core tissue procurement rates), a new novel SharkCore needle (Beacon Endoscopic, Newton, MA, USA) has been designed and approved for clinical human use by the FDA.
The objective of the study is to compare the new EUS guided histology biopsy needle SharkCore to the currently used EUS histology needle, ProCore, for the histological diagnosis and evaluation of lesions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS-FNB with ProCore needle | Active comparator | Procedure: EUS-FNB with ProCore needle, Device: ProCore needleGeneral anesthesia or conscious sedation will be started and an upper endoscopic ultrasound will be inserted into the participants mouth and advanced to the site of the lesion. The lesion will be punctured by the ProCore needle, then the stylet is completely removed, and negative suction pressure is applied using a 10 ml syringe for 30 seconds while the needle is stationary with the target. Then, the needle is moved back and forth several times within the target, utilizing the fanning technique. Finally, suction is released by closing the lock of the syringe and the needle is removed. |
| EUS-FNB with SharkCore needle | Active comparator | Procedure: EUS-FNB with SharkCore needle, Device: SharkCore needleThe procedure will be done in the same manner with same endoscopic technique and method of tissue procurement. The only difference will be using the SharkCore needle to acquire tissue. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients ≥ 18 years of age referred for EUS
- Mesenchymal tumors
- Autoimmune pancreatitis
- Granulomatous disease
- Indeterminate hepatitis
Key exclusion criteria (7 listed)
- Uncorrectable coagulopathy (INR > 1.5)
- Uncorrectable thrombocytopenia (platelet < 50,000)
- Uncooperative patients
- Pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures)
- Refusal to 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 |
|---|---|---|
| EUS-FNB with ProCore needleThe use of the standard ProCore needle to acquire diagnostic tissue | Procedure or surgery | EUS-FNB with ProCore needle |
| EUS-FNB with SharkCore needleThe use of new SharkCore needle to acquire diagnostic tissue | Procedure or surgery | EUS-FNB with SharkCore needle |
| ProCore needleThis is the standard needle used currently to procure tissue from lesions under endoscopic ultrasound guidance | Device | EUS-FNB with ProCore needle |
| SharkCore needleThis is the new FDA approved needle for tissue procurement under endoscopic ultrasound guidance. | Device | EUS-FNB with SharkCore needle |
Primary outcome
Diagnostic accuracy of needle as assessed by diagnostic yield of needle and final diagnosis method
Time frame: Up to 1 month
The final diagnosis of tissue from needle will be compared to the final diagnosis reached either by surgical removal of mass or other method of biopsy
3 secondary outcomes
Number of passes to procure core tissue from needle
Time frame: During procedure
Safety of tissue procurement by needle
Time frame: Up to 1 year
Procedure time
Time frame: During procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
Mouen Khashab, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EUS-FNB with ProCore needle, EUS-FNB with SharkCore needle and ProCore needle in people with Mesenchymal Tumor and Autoimmune Pancreatitis, run by Johns Hopkins University 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 10 inclusion and 7 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: withdrawn, as of the sponsor's last update on 15 May 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 of needle as assessed by diagnostic yield of needle and final diagnosis method (time frame: Up to 1 month). 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 15 May 2017.