Assessing Effects of Heparin Priming and Pass Number on Tissue Quality of Fine Needle Biopsies

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Assessing Effects of Heparin Priming and Pass Number on Tissue Quality of Fine Needle Biopsies

Conditions
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Pancreas, Mass Lesion

Intervention / Treatment
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* Combination Product: Heparin will be used for needle priming (BD PosiFlush™ Pre-Filled Heparin Lock Flush Syringe)
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: After the amendment (Ame00126774) 98 more participants will be randomized.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heparin priming biopsies<br> | Combination Product: Heparin will be used for needle priming (BD PosiFlush™ Pre-Filled Heparin Lock Flush Syringe)<br>* 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.<br>|
| Active Comparator: Standard of care (saline)<br> | Drug: Saline<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 
| Tissue Diagnosis | H&E slides from the pass 1, 2, and 3 to see if a diagnosis can be made. | Day 1 (biopsy tissue obtained) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. This will be calculated and reported as total number of cells divided by total area of the biopsy. | Day 1 (biopsy tissue obtained) | 
| Percentage of patients that needed repeated Endoscopic ultrasound (EUS) biopsy | Data will be collected from standard of care records. | 4 weeks (after initial biopsy) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biopsy, pancreas lesion, endoscopic fine needle biopsy