Trial Outcomes & Findings for Assessing Effects of Heparin Priming and Pass Number on Tissue Quality of Fine Needle Biopsies (NCT NCT04764396)
NCT ID: NCT04764396
Last Updated: 2024-06-20
Results Overview
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.
TERMINATED
NA
2 participants
Day 1 (biopsy tissue obtained)
2024-06-20
Participant Flow
Participant milestones
| Measure |
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.
|
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.
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|---|---|---|
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Overall Study
STARTED
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1
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1
|
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Overall Study
COMPLETED
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0
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1
|
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Overall Study
NOT COMPLETED
|
1
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0
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Reasons for withdrawal
| Measure |
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.
|
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.
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|---|---|---|
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Overall Study
Physician Decision
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1
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0
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Baseline Characteristics
Assessing Effects of Heparin Priming and Pass Number on Tissue Quality of Fine Needle Biopsies
Baseline characteristics by cohort
| Measure |
Heparin Priming Biopsies
n=1 Participants
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.
|
Standard of Care (Saline)
n=1 Participants
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.
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Total
n=2 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Customized
Age 18 - 85
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1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
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0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1 (biopsy tissue obtained)Population: 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."
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1 (biopsy tissue obtained)Population: 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."
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 (biopsy tissue obtained)Population: 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."
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 (biopsy tissue obtained)Population: 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."
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeks (after initial biopsy)Population: 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."
This outcome will report the number of participants who required a second EUS biopsy. Data was collected from health records.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 (biopsy tissue obtained)Population: 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."
H\&E slides from the pass 1, 2, and 3 will be reviewed to see if a diagnosis can be made.
Outcome measures
Outcome data not reported
Adverse Events
Heparin Priming Biopsies
Standard of Care (Saline)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place