PancreasNCT04764396
Assessing Effects of Heparin Priming and Pass Number on Tissue Quality of Fine Needle Biopsies
A study testing Heparin will be used for needle priming (BD PosiFlush™ Pre-Filled Heparin Lock Flush Syringe) and Saline in people with Pancreas and Mass Lesion, run by University of Michigan at 1 site in United States.
Trial summary
This is a randomized study that will enroll patients scheduled for an endoscopic ultrasound biopsy of a pancreas lesion to be in the heparin or saline group during the procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas, Mass Lesion
- What is being tested?
- Heparin will be used for needle priming (BD PosiFlush™ Pre-Filled Heparin Lock Flush Syringe) and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2021to 6 Jul 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient identified as having a possible solid pancreatic lesion on computed tomography or magnetic resonance
- Patient scheduled for Endoscopic ultrasound (EUS) for sampling of pancreatic mass
Who cannot join
- known history of coagulopathy
- history of heparin allergy
- patients with evidence of vascular tumors on imaging
- Patients with history of chronic pancreatitis
- Pregnant patients
- Medically unstable patients
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized study that will enroll patients scheduled for an endoscopic ultrasound biopsy of a pancreas lesion to be in the heparin or saline group during the procedure.
The purpose of this study is to examine the effect of blood contamination, heparin priming of the fine needle biopsies, and pass number on tumor tissue quality in fine needle biopsies.
The hypothesis for this study is that fine needle biopsy tissue quality of pancreatic masses decreases with increasing pass number due to blood contamination; this blood contamination can be ameliorated with priming of the needle with an anticoagulant such as heparin.
Read the detailed description
A total of 3 fine-needle biopsy passes will be performed on every procedure. The tissue specimens from each of the 3 passes will be collected in 3 separate jars of 10% formalin for tissue analysis. The use of heparin flushing vs. not heparin flushing will be based on their randomized group assignments.
In the heparin arm, between passes, after tissue is extracted from the needle, the needle will be flushed with 1 mL of heparin (100 USP/mL) and flushed with air before the next pass will be made. This means the needle will have no heparin during the first pass. In the standard of care arm, between passes, after tissue is extracted from the needle, the needle will be flushed with saline and/or air as per current standards of care.
This study was amended at the Institutional Review Board (IRB) after having enrolled only two participants. Following the amendment, the responsible party changed and with that change some adjustments were made to the interventions, analysis and some outcomes.
- Conditions
- Pancreas, Mass Lesion
- Being tested
- Heparin will be used for needle priming (BD PosiFlush™ Pre-Filled Heparin Lock Flush Syringe), Saline
- Keywords
- biopsy, pancreas lesion, endoscopic fine needle biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin will be used for needle priming (BD PosiFlush™ Pre-Filled Heparin Lock Flush Syringe)Combination product
The fine needle biopsy (FNB) needle will be flushed with 1 mL of heparin (100 USP/mL) and then flushed with air. Pass 1, 2, and 3 will be collected in separate jars and sent to pathology, as per standard clinical procedures. Between passes, after tissue is extracted from the needle, the needle will be flushed with 1 mL of heparin (100 USP/mL) and flushed with air before next pass is made.
SalineDrug
FNB will be performed as current standard methods in the medical procedure unit without the use of heparin priming. Pass 1, 2, and 3 will be collected in separate jars and sent to pathology, as per standard clinical procedures. Between passes, after tissue is extracted from the needle, the needle will be flushed saline and or air as per current standards of care.
| Study group | Role | What they receive |
|---|---|---|
| Heparin priming biopsies | Experimental | Not described Receives: Combination Product: Heparin will be used for needle priming (BD PosiFlush™ Pre-Filled Heparin Lock Flush Syringe) |
| Standard of care (saline) | Active comparator | Not described Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cellularity Captured in Fine Needle Biopsies for the Heparin Group
Hematoxylin and eosin (H\&E) slides from the passes 1, 2, and 3 will be compared. The number of cells present on each H\&E slide will be quantified by using image processing software. This value will be total number of cells divided by the total area of the biopsy.
Measured: Day 1 (biopsy tissue obtained)
Blood Contamination in Fine Needle Biopsies for the Heparin Group
H\&E slides from passes 1, 2, and 3 will be reviewed. The amount of blood present on each H\&E slide will be quantified by using image processing software (blood contamination area between passes).
Measured: Day 1 (biopsy tissue obtained)
Secondary outcomes (3)
Blood Contamination in Successive Fine Needle Biopsies Saline Group
H\&E slides from the pass 1, 2, and 3 will be reviewed. The amount of blood present on each H\&E slide will be quantified by using image processing software (blood contamination area between passes).
Measured: Day 1 (biopsy tissue obtained)
Cellularity Captured in Successive Fine Needle Biopsies Saline Group
H\&E slides from the passes 1, 2, and 3 will be reviewed. The number of cells present on each H\&E slide will be quantified by using image processing software.
The data for this outcome will be calculated and reported as total number of cells divided by total area of the biopsy.
Measured: Day 1 (biopsy tissue obtained)
Participants Who Needed Repeated Endoscopic Ultrasound (EUS) Biopsy
This outcome will report the number of participants who required a second EUS biopsy. Data was collected from health records.
Measured: 4 weeks (after initial biopsy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start12 Mar 2021
- Primary completion6 Apr 2021
- Study completion6 Jul 2021
Why it stopped: Lack of funding and change in research direction.
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.
- Other trials for PancreasStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After the amendment (Ame00126774) 98 more participants will be randomized.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Machicado, MD, MPH, University of Michigan
- Investigators
- Jorge Machicado, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764396
- Sponsor's protocol ID
- HUM00172203
- Status last verified
- May 2024
- First submitted
- 17 Feb 2021
- Last updated
- 20 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: There is a plan to make individual participant data (IPD) and related data dictionaries available. All IPD that underlie results in our planned publication, after deidentification. IPD will be uploaded to a data repository to be determined at time of publication.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Effects of Heparin Priming and Pass Number on Tissue Quality of Fine Needle Biopsies
- ClinicalTrials.gov ID
- NCT04764396
- Acronym / sponsor ID
- HUM00172203
- Conditions
- Pancreas, Mass Lesion
- Keywords
- biopsy, pancreas lesion, endoscopic fine needle biopsy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding and change in research direction.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 6 Apr 2021 (actual)
- Study completion
- 6 Jul 2021 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Posted 20 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized study that will enroll patients scheduled for an endoscopic ultrasound biopsy of a pancreas lesion to be in the heparin or saline group during the procedure.
The purpose of this study is to examine the effect of blood contamination, heparin priming of the fine needle biopsies, and pass number on tumor tissue quality in fine needle biopsies.
The hypothesis for this study is that fine needle biopsy tissue quality of pancreatic masses decreases with increasing pass number due to blood contamination; this blood contamination can be ameliorated with priming of the needle with an anticoagulant such as heparin.
Detailed description
A total of 3 fine-needle biopsy passes will be performed on every procedure. The tissue specimens from each of the 3 passes will be collected in 3 separate jars of 10% formalin for tissue analysis. The use of heparin flushing vs. not heparin flushing will be based on their randomized group assignments.
In the heparin arm, between passes, after tissue is extracted from the needle, the needle will be flushed with 1 mL of heparin (100 USP/mL) and flushed with air before the next pass will be made. This means the needle will have no heparin during the first pass. In the standard of care arm, between passes, after tissue is extracted from the needle, the needle will be flushed with saline and/or air as per current standards of care.
This study was amended at the Institutional Review Board (IRB) after having enrolled only two participants. Following the amendment, the responsible party changed and with that change some adjustments were made to the interventions, analysis and some outcomes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- After the amendment (Ame00126774) 98 more participants will be randomized.
| Arm | Type | Receives |
|---|---|---|
| Heparin priming biopsies | Experimental | Combination Product: Heparin will be used for needle priming (BD PosiFlush™ Pre-Filled Heparin Lock Flush Syringe) |
| Standard of care (saline) | Active comparator | Drug: Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient identified as having a possible solid pancreatic lesion on computed tomography or magnetic resonance
- Patient scheduled for Endoscopic ultrasound (EUS) for sampling of pancreatic mass
Key exclusion criteria (6 listed)
- known history of coagulopathy
- history of heparin allergy
- patients with evidence of vascular tumors on imaging
- Patients with history of chronic pancreatitis
- Pregnant patients
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 |
|---|---|---|
| Heparin will be used for needle priming (BD PosiFlush™ Pre-Filled Heparin Lock Flush Syringe)The fine needle biopsy (FNB) needle will be flushed with 1 mL of heparin (100 USP/mL) and then flushed with air. Pass 1, 2, and 3 will be collected in separate jars and sent to pathology, as per standard clinical procedures. Between passes, after tissue is extracted from the needle, the needle will be flushed with 1 mL of heparin (100 USP/mL) and flushed with air before next pass is made. | Combination product | Heparin priming biopsies |
| SalineFNB will be performed as current standard methods in the medical procedure unit without the use of heparin priming. Pass 1, 2, and 3 will be collected in separate jars and sent to pathology, as per standard clinical procedures. Between passes, after tissue is extracted from the needle, the needle will be flushed saline and or air as per current standards of care. | Drug | Standard of care (saline) |
Primary outcome
Cellularity Captured in Fine Needle Biopsies for the Heparin Group
Time frame: Day 1 (biopsy tissue obtained)
Hematoxylin and eosin (H\&E) slides from the passes 1, 2, and 3 will be compared. The number of cells present on each H\&E slide will be quantified by using image processing software. This value will be total number of cells divided by the total area of the biopsy.
Blood Contamination in Fine Needle Biopsies for the Heparin Group
Time frame: Day 1 (biopsy tissue obtained)
H\&E slides from passes 1, 2, and 3 will be reviewed. The amount of blood present on each H\&E slide will be quantified by using image processing software (blood contamination area between passes).
3 secondary outcomes
Blood Contamination in Successive Fine Needle Biopsies Saline Group
Time frame: Day 1 (biopsy tissue obtained)
Cellularity Captured in Successive Fine Needle Biopsies Saline Group
Time frame: Day 1 (biopsy tissue obtained)
Participants Who Needed Repeated Endoscopic Ultrasound (EUS) Biopsy
Time frame: 4 weeks (after initial biopsy)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. There is a plan to make individual participant data (IPD) and related data dictionaries available. All IPD that underlie results in our planned publication, after deidentification. IPD will be uploaded to a data repository to be determined at time of publication.
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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.
Jorge Machicado, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heparin will be used for needle priming (BD PosiFlush™ Pre-Filled Heparin Lock Flush Syringe) and Saline in people with Pancreas and Mass Lesion, run by University of Michigan 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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 20 Jun 2024. 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 20 Jun 2024). 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?
Cellularity Captured in Fine Needle Biopsies for the Heparin Group (time frame: Day 1 (biopsy tissue obtained)). The study lists 2 primary outcomes in all. 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 20 Jun 2024.