Mass Lesion, Pancreas
Conditions
Keywords
biopsy, pancreas lesion, endoscopic fine needle biopsy
Brief 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. 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.
Interventions
COMBINATION_PRODUCTHeparin 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.
DRUGSaline
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.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The pathologist will be blinded to the allocation
Intervention model description
After the amendment (Ame00126774) 98 more participants will be randomized.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cellularity Captured in Fine Needle Biopsies for the Heparin Group | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Contamination in Successive Fine Needle Biopsies Saline Group | Day 1 (biopsy tissue obtained) | 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). |
| Cellularity Captured in Successive Fine Needle Biopsies Saline Group | Day 1 (biopsy tissue obtained) | 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. |
| Participants Who Needed Repeated Endoscopic Ultrasound (EUS) Biopsy | 4 weeks (after initial biopsy) | This outcome will report the number of participants who required a second EUS biopsy. Data was collected from health records. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Tissue Diagnosis | Day 1 (biopsy tissue obtained) | H&E slides from the pass 1, 2, and 3 will be reviewed to see if a diagnosis can be made. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1 |
| 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. | 1 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Heparin Priming Biopsies | Standard of Care (Saline) | Total |
|---|---|---|---|
| Age, Customized Age 18 - 85 | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 1 participants | 1 participants | 2 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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).
Time frame: 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.
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.
Time frame: 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.
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).
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.