Pancreatic TumorNCT02534246
Head to Head Comparison of Two Needles EUS Guided FNB
A study testing Ultrasound biopsy needle Echo Tip ProCore and Ultrasound biopsy needle SharkCore in people with Pancreatic Tumor, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The aim of this study is to evaluate and compare the diagnostic accuracy and specimen adequacy of two ultrasound biopsy needles. These are two existing FDA approved tissue biopsy regimens, with respect to diagnosis of solid pancreatic lesions. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Pancreatic Tumor
- What is being tested?
- Ultrasound biopsy needle Echo Tip ProCore and Ultrasound biopsy needle SharkCore
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Oct 2017
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects aged 18-90 of any gender, ethnicity and race that are referred to endoscopy for endoscopic ultrasound guided tissue acquisition for solid pancreatic mass.
- Voluntary enrollment
- Ability to give written informed consent
- Subjects must have a pancreatic mass detected by radiology (CT or MRI) or ultrasound or at the time of EUS.
Who cannot join
- Patients with coagulopathy with an elevated INR>2
- Any individual who cannot provide one's voluntary informed written consent.
- Any pre-existing or discovered medical condition that may at the discretion of investigator interfere with the completion of and/ or participation in existing protocol.
- Pregnancy
- Less than 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: A Paired Prospective, Single Blinded Study of the Diagnostic Accuracy and Specimen Adequacy of Two Endoscopic Tissue Biopsy Needles for Diagnosis Solid Pancreatic Mass
The aim of this study is to evaluate and compare the diagnostic accuracy and specimen adequacy of two ultrasound biopsy needles. These are two existing FDA approved tissue biopsy regimens, with respect to diagnosis of solid pancreatic lesions.
Read the detailed description
EUS guided core biopsy using various needle designs and sizes, seems to be a promising technique to procure tissue in solid pancreatic masses for making an accurate histological diagnosis. EUS-guided core biopsies of pancreas may aid in patients with non-diagnostic EUS-FNA samples and institutions where they do not have on-site cytopathology available for prompt evaluation of tissue adequacy. Making an accurate diagnosis not only assists in planning appropriate treatment but also may decrease morbidity/mortality from unnecessary surgeries.
Our goal is to evaluate and compare the diagnostic accuracy and specimen adequacy of the Cook Medical 25 gauge ProCore ultrasound biopsy needle and the Medtronic (Beacon) 25 gauge SharkCore ultrasound biopsy needle. We hypothesize the endoscopic ultrasound tissue biopsy will not be different in diagnostic accuracy of solid pancreatic lesions when using a 25 gauge SharkCore ultrasound biopsy needle in comparison with the 25 gauge ProCore ultrasound biopsy needle.
This is a non- inferior paired, prospective, single-blind study design in which patients undergoing EUS for a solid pancreatic mass. Two biopsies with each of the two endoscopic needles of interest in this study will be used in random order. The biopsy needle passed first will be randomized, after which the two needles will be alternated for each of the remaining biopsies. Randomization will occur in permuted blocks of 3. Physician will record the ease/ difficulty of obtaining each of the 4 biopsies on a scale of 1 to 5. Also, they record the needle visibility on ultrasound. The biopsy site will be examined for evidence of bleeding. Biopsies will be sent to the pathology laboratory in a blinded fashion in coded containers, where pathologist determine the number of adequate biopsies out of two passes of each needle.The pathologist will also provide a scale of perceived diagnostic usefulness of material in a blinded fashion. Post procedure care will including a letter to referring physician with recommendations for treatment and follow up.
This study include 30 patients referred to Hershey Medical Center.
- Conditions
- Pancreatic Tumor
- Being tested
- Ultrasound biopsy needle Echo Tip ProCore, Ultrasound biopsy needle SharkCore
- Keywords
- Core tissue biopsy, Core needle biopsy, EUS, Fine needle biopsy, Fine needle aspiration
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound biopsy needle Echo Tip ProCoreDevice
Two passes preformed with Echo Tip ProCore ultrasound biopsy needle (Cook Medical 25 gauge) and two passes will be performed using SharkCore ultrasound biopsy needle (Medtronic [Beacon] 25 gauge) from single lesion.
Ultrasound biopsy needle SharkCoreDevice
| Study group | Role | What they receive |
|---|---|---|
| Pro Core EUS guided Fine Needle Biopsy | Experimental | Echo Tip ProCore ultrasound biopsy needle (Cook Medical 25 gauge) with reverse bevel design for diagnosis of pancreatic lesions. Receives: Device: Ultrasound biopsy needle Echo Tip ProCore |
| Shark Core EUS guided Fine Needle Biopsy | Experimental | SharkCore ultrasound biopsy needle (Medtronic [Beacon] 25 gauge) with six cutting edge surfaces and an opposing bevel design for diagnosis of pancreatic lesions. Receives: Device: Ultrasound biopsy needle SharkCore |
What is being measured
The primary outcome is the main question the study is designed to answer.
Direct Comparison of pancreatic mass histologic tissue adequacy using two EUS guided fine needle biopsy needles
Head to head comparison of tissue adequacy for solid pancreatic lesions using two 25 gauge EUS guided fine needle biopsy platforms - ProCore vs SharkCore.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study startAug 2016
- Primary completionOct 2016 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic TumorStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John M. Levenick, Milton S. Hershey Medical Center
- Investigators
- John M Levenick, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534246
- Sponsor's protocol ID
- STUDY2970
- Status last verified
- Sep 2016
- First submitted
- 13 Aug 2015
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Paired Prospective, Single Blinded Study of the Diagnostic Accuracy and Specimen Adequacy of Two Endoscopic Tissue Biopsy Needles for Diagnosis Solid Pancreatic Mass
- ClinicalTrials.gov ID
- NCT02534246
- Acronym / sponsor ID
- STUDY2970
- Conditions
- Pancreatic Tumor
- Keywords
- Core tissue biopsy, Core needle biopsy, EUS, Fine needle biopsy, Fine needle aspiration
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 27 Aug 2015 (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.
The aim of this study is to evaluate and compare the diagnostic accuracy and specimen adequacy of two ultrasound biopsy needles. These are two existing FDA approved tissue biopsy regimens, with respect to diagnosis of solid pancreatic lesions.
Detailed description
EUS guided core biopsy using various needle designs and sizes, seems to be a promising technique to procure tissue in solid pancreatic masses for making an accurate histological diagnosis. EUS-guided core biopsies of pancreas may aid in patients with non-diagnostic EUS-FNA samples and institutions where they do not have on-site cytopathology available for prompt evaluation of tissue adequacy. Making an accurate diagnosis not only assists in planning appropriate treatment but also may decrease morbidity/mortality from unnecessary surgeries.
Our goal is to evaluate and compare the diagnostic accuracy and specimen adequacy of the Cook Medical 25 gauge ProCore ultrasound biopsy needle and the Medtronic (Beacon) 25 gauge SharkCore ultrasound biopsy needle. We hypothesize the endoscopic ultrasound tissue biopsy will not be different in diagnostic accuracy of solid pancreatic lesions when using a 25 gauge SharkCore ultrasound biopsy needle in comparison with the 25 gauge ProCore ultrasound biopsy needle.
This is a non- inferior paired, prospective, single-blind study design in which patients undergoing EUS for a solid pancreatic mass. Two biopsies with each of the two endoscopic needles of interest in this study will be used in random order. The biopsy needle passed first will be randomized, after which the two needles will be alternated for each of the remaining biopsies. Randomization will occur in permuted blocks of 3. Physician will record the ease/ difficulty of obtaining each of the 4 biopsies on a scale of 1 to 5. Also, they record the needle visibility on ultrasound. The biopsy site will be examined for evidence of bleeding. Biopsies will be sent to the pathology laboratory in a blinded fashion in coded containers, where pathologist determine the number of adequate biopsies out of two passes of each needle.The pathologist will also provide a scale of perceived diagnostic usefulness of material in a blinded fashion. Post procedure care will including a letter to referring physician with recommendations for treatment and follow up.
This study include 30 patients referred to Hershey Medical Center.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pro Core EUS guided Fine Needle Biopsy | Experimental | Device: Ultrasound biopsy needle Echo Tip ProCoreEcho Tip ProCore ultrasound biopsy needle (Cook Medical 25 gauge) with reverse bevel design for diagnosis of pancreatic lesions. |
| Shark Core EUS guided Fine Needle Biopsy | Experimental | Device: Ultrasound biopsy needle SharkCoreSharkCore ultrasound biopsy needle (Medtronic [Beacon] 25 gauge) with six cutting edge surfaces and an opposing bevel design for diagnosis of pancreatic lesions. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult subjects aged 18-90 of any gender, ethnicity and race that are referred to endoscopy for endoscopic ultrasound guided tissue acquisition for solid pancreatic mass.
- Voluntary enrollment
- Ability to give written informed consent
- Subjects must have a pancreatic mass detected by radiology (CT or MRI) or ultrasound or at the time of EUS.
Key exclusion criteria (5 listed)
- Patients with coagulopathy with an elevated INR>2
- Any individual who cannot provide one's voluntary informed written consent.
- Any pre-existing or discovered medical condition that may at the discretion of investigator interfere with the completion of and/ or participation in existing protocol.
- Pregnancy
- Less than 18 years old
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 |
|---|---|---|
| Ultrasound biopsy needle Echo Tip ProCoreTwo passes preformed with Echo Tip ProCore ultrasound biopsy needle (Cook Medical 25 gauge) and two passes will be performed using SharkCore ultrasound biopsy needle (Medtronic [Beacon] 25 gauge) from single lesion. | Device | Pro Core EUS guided Fine Needle Biopsy |
| Ultrasound biopsy needle SharkCore | Device | Shark Core EUS guided Fine Needle Biopsy |
Primary outcome
Direct Comparison of pancreatic mass histologic tissue adequacy using two EUS guided fine needle biopsy needles
Time frame: 1year
Head to head comparison of tissue adequacy for solid pancreatic lesions using two 25 gauge EUS guided fine needle biopsy platforms - ProCore vs SharkCore.
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 13 Sep 2016.
Related trials for Pancreatic Tumor
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
John M Levenick, MD principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound biopsy needle Echo Tip ProCore and Ultrasound biopsy needle SharkCore in people with Pancreatic Tumor, run by Milton S. Hershey Medical Center 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 4 inclusion and 5 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 13 Sep 2016. 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?
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?
Direct Comparison of pancreatic mass histologic tissue adequacy using two EUS guided fine needle biopsy needles (time frame: 1year). 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 13 Sep 2016.