Clinical trial NCT04764396: Assessing Effects of Heparin Priming and Pass Number on Tissue Quality of Fine Needle Biopsies
Official title: Assessing Effects of Heparin Priming and Pass Number on Tissue Quality of Fine Needle Biopsies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pancreas
Mass Lesion
Keywords: biopsy
pancreas lesion
endoscopic fine needle biopsy
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After the amendment (Ame00126774) 98 more participants will be randomized.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cellularity Captured in Fine Needle Biopsies for the Heparin Group
timeFrame: Day 1 (biopsy tissue obtained)
measure: Blood Contamination in Fine Needle Biopsies for the Heparin Group
timeFrame: Day 1 (biopsy tissue obtained)
Secondary outcomes:
measure: Blood Contamination in Successive Fine Needle Biopsies Saline Group
timeFrame: Day 1 (biopsy tissue obtained)
measure: Cellularity Captured in Successive Fine Needle Biopsies Saline Group
timeFrame: Day 1 (biopsy tissue obtained)
measure: Participants Who Needed Repeated Endoscopic Ultrasound (EUS) Biopsy
timeFrame: 4 weeks (after initial biopsy)
Other outcomes:
measure: Tissue Diagnosis
timeFrame: Day 1 (biopsy tissue obtained)
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jorge Machicado, MD
role: PRINCIPAL_INVESTIGATOR
References: