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

Sponsor

University of Michigan (Other)

Overall Status

Recruiting

CT.gov ID

NCT04764396

Collaborator

(none)

100

Enrollment

Location

Arms

40.7

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized study that will enroll patients scheduled for an endoscopic 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.

Condition or Disease	Intervention/Treatment	Phase
Pancreas Mass Lesion	Combination Product: Heparin will be used for needle priming (BD PosiFlush™ Pre-Filled Heparin Lock Flush Syringe) Drug: Saline	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

The pathologist will be blinded to the allocation

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Mar 12, 2021

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Heparin priming biopsies	Combination Product: Heparin will be used for needle priming (BD PosiFlush™ Pre-Filled Heparin Lock Flush Syringe) The needle will be flushed with 1 milliliter (mL) of heparin (100 USP/mL) and then flushed with air. The first two passes will be collected for clinical purposes and sent to pathology per standard clinical procedures. Pass 3 will be obtained for research purposes and placed in a separate formalin jar for research. Between passes (after pass 1 and 2) 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.
Active Comparator: Standard of care (saline)	Drug: Saline The first two passes will be collected for clinical purposes and sent to pathology per standard clinical procedures. Between passes and after tissue is extracted from the needle, the needle will be flushed with 1 mL of saline, as per standard clinical practice, and flushed with air before next pass is made. Pass 3 will be taken for research purposes and placed in a separate formalin jar for research. Between passes (after pass 1 and 2) after tissue is extracted from the needle, the needle will be flushed with 1 mL of with 1 mL of saline, as per standard clinical practice, and flushed with air before next pass is made.

Arm

Intervention/Treatment

Experimental: Heparin priming biopsies

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

The needle will be flushed with 1 milliliter (mL) of heparin (100 USP/mL) and then flushed with air. The first two passes will be collected for clinical purposes and sent to pathology per standard clinical procedures. Pass 3 will be obtained for research purposes and placed in a separate formalin jar for research. Between passes (after pass 1 and 2) 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.

Active Comparator: Standard of care (saline)

Drug: Saline

The first two passes will be collected for clinical purposes and sent to pathology per standard clinical procedures. Between passes and after tissue is extracted from the needle, the needle will be flushed with 1 mL of saline, as per standard clinical practice, and flushed with air before next pass is made. Pass 3 will be taken for research purposes and placed in a separate formalin jar for research. Between passes (after pass 1 and 2) after tissue is extracted from the needle, the needle will be flushed with 1 mL of with 1 mL of saline, as per standard clinical practice, and flushed with air before next pass is made.

Outcome Measures

Primary Outcome Measures

Tissue quality in fine needle biopsies for the heparin group [Day 1 (biopsy tissue obtained)]
Hematoxylin and eosin stain (H&E) slides from the pass 1 and 2 will be compared to H&E slides from pass 3. Each slide will be examined to determine if there is adequate quality. A Pathologist will use a scale to rate the quality (0,1,2, 3) with 3 being the best quality.
Cellularity captured in fine needle biopsies for the heparin group [Day 1 (biopsy tissue obtained)]
H&E slides from the pass 1 and 2 will be compared to H&E slides from pass 3.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 the pass 1 and 2 will be compared to H&E slides from pass 3. The amount of blood present on each H&E slide will be quantified by using image processing software. This value will be total area of blood divided by total area of the biopsy.
Tissue Diagnosis [Day 1 (biopsy tissue obtained)]
Hematoxylin and eosin stain (H&E) slides from the pass 1 and 2 will be compared to H&E slides from pass 3 to see if a diagnosis can be made.

Secondary Outcome Measures

Blood contamination in successive fine needle biopsies saline group [Day 1 (biopsy tissue obtained)]
H&E slides from the pass 1 and 2 will be compared to H&E slides from pass 3. The amount of blood present on each H&E slide will be quantified by using image processing software. This will be calculated by the values from pass 1 plus pass 2, and the value from pass 3 and the value will be total area of blood divided by total area of the biopsy.
Cellularity captured in successive fine needle biopsies saline group [Day 1 (biopsy tissue obtained)]
H&E slides from the pass 1 and 2 will be compared to H&E slides from pass 3.The number of cells present on each H&E slide will be quantified by using image processing software. This will be calculated by the values from pass 1 plus pass 2 and the value from pass 3, and the value will be reported as total number of cells divided by total area of the biopsy.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients identified as having a possible solid lesion in their pancreas on radiographic imaging
scheduled for endoscopic fine needle biopsy (FNB) for clinical purposes.

Exclusion Criteria:

known history of coagulopathy
history of heparin allergy
patients with evidence of vascular tumors on imaging

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

University of Michigan

Investigators

Principal Investigator: Richard Kwon, MD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Richard Kwon, MD, Associate Professor of Internal Medicine, University of Michigan

ClinicalTrials.gov Identifier:

NCT04764396

Other Study ID Numbers:

HUM00172203

First Posted:

Feb 21, 2021

Last Update Posted:

Apr 13, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Richard Kwon, MD, Associate Professor of Internal Medicine, University of Michigan

biopsy

pancreas lesion

endoscopic fine needle biopsy

Additional relevant MeSH terms:

Heparin

Calcium heparin

Study Results

No Results Posted as of Apr 13, 2022