NCT04764396

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreas
• Mass Lesion

Interventions

Type	Name	Description
COMBINATION_PRODUCT	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.
DRUG	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.

Timeline

• Start date: 2021-03-12
• Primary completion: 2021-04-06
• Completion: 2021-07-06
• First posted: 2021-02-21
• Last updated: 2024-06-20
• Results posted: 2024-06-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study