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

University of Michigan

Status: Terminated

Conditions: Pancreas; Mass Lesion

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04764396

HUM00172203

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2 participants in 2 patient groups

Heparin priming biopsies

Experimental group

Treatment:

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

Standard of care (saline)

Active Comparator group

Treatment:

Drug: Saline