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

NCT04764396 | Terminated Results FDA Device

• 1 other identifier: HUM00172203
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreas; Mass Lesion

Keywords

biopsy; pancreas lesion; endoscopic fine needle biopsy

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (3)

• Blood Contamination in Successive Fine Needle Biopsies Saline Group

  Day 1 (biopsy tissue obtained)

• Cellularity Captured in Successive Fine Needle Biopsies Saline Group

  Day 1 (biopsy tissue obtained)

• Participants Who Needed Repeated Endoscopic Ultrasound (EUS) Biopsy

  4 weeks (after initial biopsy)

Other Outcomes (1)

• Tissue Diagnosis

  Day 1 (biopsy tissue obtained)

Study Arms (2)

Heparin priming biopsies

EXPERIMENTAL

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

Standard of care (saline)

ACTIVE COMPARATOR

Drug: Saline

Interventions

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

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.

Heparin priming biopsies

Saline DRUG

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.

Standard of care (saline)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Eileen Carpenter
• Organization: University of Michigan

eicarpen@med.umich.edu

734-615-3948

Study Officials

• Jorge Machicado, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The pathologist will be blinded to the allocation
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Internal Medicine

Model Details: After the amendment (Ame00126774) 98 more participants will be randomized.

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 21, 2021
• Study Start: March 12, 2021
• Primary Completion: April 6, 2021
• Study Completion: July 6, 2021
• Last Updated: June 20, 2024
• Results First Posted: June 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD will be available beginning 3 months following article publication and at a minimal ending 5 years following article publication.
• Access Criteria: Anyone who wishes to access the data may do so, following the requirements specified by the repository.

Locations

US (1)