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

Pancreas Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04764396
• Other study ID #: HUM00172203
• Status: Terminated
• Phase: N/A
• Start date: March 12, 2021
• Est. completion date: July 6, 2021

Study information

• Verified date: May 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 6, 2021
• Est. primary completion date: April 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mass Lesion
• Pancreas

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tissue Diagnosis	H&E slides from the pass 1, 2, and 3 will be reviewed to see if a diagnosis can be made.	Day 1 (biopsy tissue obtained)
Primary	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)
Primary	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	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)
Secondary	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.; The data for this outcome will be calculated and reported as total number of cells divided by total area of the biopsy.	Day 1 (biopsy tissue obtained)
Secondary	Participants Who Needed Repeated Endoscopic Ultrasound (EUS) Biopsy	This outcome will report the number of participants who required a second EUS biopsy. Data was collected from health records.	4 weeks (after initial biopsy)