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

Not Applicable

Terminated

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

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Standard of care (saline)	Saline	-
Heparin priming biopsies	Heparin will be used for needle priming (BD PosiFlush™ Pre-Filled Heparin Lock Flush Syringe)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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).
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.