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

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreas; Mass Lesion
• Intervention / Treatment: Combination product: Heparin will be used for needle priming (BD PosiFlush™ Pre-Filled Heparin Lock Flush Syringe); Drug: Saline

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Principal Investigator: Jorge Machicado, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 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.
Active Comparator: Standard of care (saline)	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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Jorge Machicado, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2021
• Primary Completion (Anticipated): August 1, 2025
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: biopsy; pancreas lesion; endoscopic fine needle biopsy
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Calcium heparin
• Other Study ID Numbers: HUM00172203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: There is a plan to make individual participant data (IPD) and related data dictionaries available. All IPD that underlie results in our planned publication, after deidentification. IPD will be uploaded to a data repository to be determined at time of publication.
• IPD Sharing Time Frame: IPD will be available beginning 3 months following article publication and at a minimal ending 5 years following article publication.
• IPD Sharing Access Criteria: Anyone who wishes to access the data may do so, following the requirements specified by the repository.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No