← Back to Search

Heparin Priming for Pancreatic Mass Biopsy

N/A
Recruiting
Led By Jorge Machicado, MD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
scheduled for endoscopic fine needle biopsy (FNB) for clinical purposes
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks (after initial biopsy)
Awards & highlights

Study Summary

This trial will enroll patients who are scheduled for an endoscopic biopsy of a pancreas lesion. The patients will be randomly assigned to either the heparin or saline group. 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.

Who is the study for?
This trial is for patients who are scheduled to have an endoscopic fine needle biopsy of a suspected solid lesion in their pancreas, as seen on imaging. It's not open to those with blood clotting disorders or allergies to heparin, nor patients with vascular tumors identified by imaging.Check my eligibility
What is being tested?
The study is testing whether using heparin (an anticoagulant) instead of saline to prime the biopsy needle can reduce blood contamination and improve tissue quality from pancreatic mass biopsies. Patients will be randomly assigned to receive either heparin or saline during the procedure.See study design
What are the potential side effects?
Potential side effects may include bleeding due to heparin's blood-thinning properties and allergic reactions in individuals sensitive to heparin. However, since this is a local application during a biopsy, systemic side effects are expected to be minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a needle biopsy through an endoscope.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks (after initial biopsy)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks (after initial biopsy) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Heparin
Heparin
Tissue Diagnosis
Secondary outcome measures
Blood contamination in successive fine needle biopsies saline group
Cellularity captured in successive fine needle biopsies saline group
Percentage of patients that needed repeated Endoscopic ultrasound (EUS) biopsy

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Heparin priming biopsiesExperimental Treatment1 Intervention
Group II: Standard of care (saline)Active Control1 Intervention

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,786 Previous Clinical Trials
6,365,422 Total Patients Enrolled
Jorge Machicado, MDPrincipal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
10 Total Patients Enrolled
Richard Kwon, MDPrincipal Investigator - University of Michigan
University of Michigan C.S. Mott Children's Hospital, University of Michigan Health System, Von Voigtlander Women's Hospital
University Of California (Medical School)
Brigham & Women'S Hospital (Residency)

Media Library

Pancreas Research Study Groups: Heparin priming biopsies, Standard of care (saline)
Pancreas Clinical Trial 2023: Fine Needle Biopsy Highlights & Side Effects. Trial Name: NCT04764396 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment of participants in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this research is actively recruiting participants. Initially posted on March 12th 2021, the trial seeks 100 individuals from a single site for participation."

Answered by AI

Are there any slots still available for enrollees in this experiment?

"Affirmative. According to the information accessible on clinicaltrials.gov, this medical trial is recruiting patients with an enrollment goal of 100 individuals across 1 site. It was initially posted in March 2021 and recently updated in April 2022."

Answered by AI

Have prior investigations explored the usage of Heparin in BD PosiFlush™ Pre-Filled Heparin Lock Flush Syringe priming?

"Currently, 36 clinical trials are underway on the efficacy of Heparin in needle priming. Of these studies, 12 have progressed to Stage 3. While most sites conducting this research can be found in Sherbrooke, Quebec; there is a total of 367 locations running examinations for this medical intervention."

Answered by AI

What therapeutic purpose is served by the frequent use of Heparin (BD PosiFlush™ Pre-Filled Heparin Lock Flush Syringe)?

"In addition to its use in medical device priming, heparin (BD PosiFlush™ Pre-Filled Heparin Lock Flush Syringe) can be employed therapeutically for sprains, unstable angina pectoris and atrial fibrillation."

Answered by AI

Does this research represent an unprecedented approach?

"Currently, there are 36 active clinical trials associated with Ash Access Technology's Heparin product (BD PosiFlush™ Pre-Filled Heparin Lock Flush Syringe) in 197 cities from 21 different nations. This drug first underwent a Phase 3 trial back in 2006 and has since gone through 620 more separate studies, involving 415 participants."

Answered by AI
~31 spots leftby Aug 2025