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Lack of funding and change in research direction.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heparin priming biopsies | Experimental |
| |
| Standard of care (saline) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | Day 1 (biopsy tissue obtained) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 1 (biopsy tissue obtained) |
| Cellularity Captured in Successive Fine Needle Biopsies Saline Group |
| Measure | Description | Time Frame |
|---|---|---|
| Tissue Diagnosis | H&E slides from the pass 1, 2, and 3 will be reviewed to see if a diagnosis can be made. | Day 1 (biopsy tissue obtained) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jorge Machicado, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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.
IPD will be available beginning 3 months following article publication and at a minimal ending 5 years following article publication.
Anyone who wishes to access the data may do so, following the requirements specified by the repository.
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| ID | Title | Description |
|---|---|---|
| FG000 | Heparin Priming Biopsies | 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. |
| FG001 | Standard of Care (Saline) | Saline: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Heparin Priming Biopsies | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | No data is presented here because, with only 1 participant per arm, it is impossible to share this data, as doing so would conflict with the required informed consent language for ACTs, which says, "This website [ClinicalTrials.gov] will not include information that can identify you" and "...At most, the website will include a summary of the results." | Posted | Day 1 (biopsy tissue obtained) |
|
4 weeks
No data is presented here because, with only 1 participant per arm, it is impossible to share this data, as doing so would conflict with the required informed consent language for ACTs, which says, "This website [ClinicalTrials.gov] will not include information that can identify you" and "...At most, the website will include a summary of the results."
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Heparin Priming Biopsies | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eileen Carpenter | University of Michigan | 734-615-3948 | eicarpen@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 15, 2023 | May 28, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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After the amendment (Ame00126774) 98 more participants will be randomized.
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The pathologist will be blinded to the allocation
|
| Saline | Drug | 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. |
|
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. |
| 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. | 4 weeks (after initial biopsy) |
| BG001 | Standard of Care (Saline) | Saline: 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Standard of Care (Saline) | Saline: 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. |
|
| Primary | 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). | No data is presented here because, with only 1 participant per arm, it is impossible to share this data, as doing so would conflict with the required informed consent language for ACTs, which says, "This website [ClinicalTrials.gov] will not include information that can identify you" and "...At most, the website will include a summary of the results." | Posted | Day 1 (biopsy tissue obtained) |
|
|
| Secondary | 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). | No data is presented here because, with only 1 participant per arm, it is impossible to share this data, as doing so would conflict with the required informed consent language for ACTs, which says, "This website [ClinicalTrials.gov] will not include information that can identify you" and "...At most, the website will include a summary of the results." | Posted | Day 1 (biopsy tissue obtained) |
|
|
| Secondary | 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. | No data is presented here because, with only 1 participant per arm, it is impossible to share this data, as doing so would conflict with the required informed consent language for ACTs, which says, "This website [ClinicalTrials.gov] will not include information that can identify you" and "...At most, the website will include a summary of the results." | Posted | Day 1 (biopsy tissue obtained) |
|
|
| Secondary | 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. | No data is presented here because, with only 1 participant per arm, it is impossible to share this data, as doing so would conflict with the required informed consent language for ACTs, which says, "This website [ClinicalTrials.gov] will not include information that can identify you" and "...At most, the website will include a summary of the results." | Posted | 4 weeks (after initial biopsy) |
|
|
| Other Pre-specified | Tissue Diagnosis | H&E slides from the pass 1, 2, and 3 will be reviewed to see if a diagnosis can be made. | No data is presented here because, with only 1 participant per arm, it is impossible to share this data, as doing so would conflict with the required informed consent language for ACTs, which says, "This website [ClinicalTrials.gov] will not include information that can identify you" and "...At most, the website will include a summary of the results." | Posted | Day 1 (biopsy tissue obtained) |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Standard of Care (Saline) | Saline: 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D017670 |
| Sodium Compounds |