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Anticoagulant Flush for Abdominal Cancer (EUS Heparin Trial)

N/A
Waitlist Available
Led By Shaffer Mok, MD
Research Sponsored by University Hospitals Cleveland Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who underwent a prior EUS-FNA/FNB for solid pancreatic mass and did not receive a conclusive diagnosis
Patients with the presence of a solid abdominal mass as seen on diagnostic imaging [ie. ultrasound (US), computer tomography (CT) or magnetic resonance imaging (MRI)] scheduled to undergo EUS examination
Must not have
Patients who cannot consent for themselves
Patients with cystic abdominal masses
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after the intervention/procedure/surgery
Awards & highlights
No Placebo-Only Group

Summary

This trial is comparing the amount and quality of tissue obtained by endoscopic ultrasound-guided fine needle biopsy when the device is flushed with an anticoagulant or saline solution, as well as the use of a microsieve.

Who is the study for?
This trial is for adults over 18 with solid abdominal tumors (liver, pancreatic, stomach, or esophageal cancer) visible on imaging tests and scheduled for EUS examination. It's not for pregnant individuals, those unable to consent, recent users of certain blood thinners (except aspirin), people with cystic masses or low platelet counts, those allergic to heparin/porcine products, or anyone with a history of heparin-induced thrombocytopenia.
What is being tested?
The study compares the effectiveness of using a wet heparinized solution versus saline in the needle during tumor sampling by EUS-FNB. Additionally, it evaluates the use of a microsieve to assess tissue quality before analysis. Participants are randomly assigned to one of these methods in this data collection study across one site in the U.S.
What are the potential side effects?
Potential side effects may include bleeding due to anticoagulant properties of heparin if used; however specific side effects related to this procedure will be monitored closely given that it involves standard diagnostic techniques.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had a biopsy for a pancreatic mass but didn't get a clear diagnosis.
Select...
I have a solid mass in my abdomen confirmed by imaging and am scheduled for an EUS exam.
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am unable to give consent for my own medical treatment.
Select...
I have cyst-like lumps in my abdomen.
Select...
I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after the intervention/procedure/surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after the intervention/procedure/surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Aggregate specimen length (ASL)
Secondary study objectives
Adequacy of diagnosis
Histology adequacy score
Length of the longest piece (LLP)
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: No heparin and microsieveExperimental Treatment2 Interventions
The needle not be prepped. The provider will expel the tissue onto the microsieve
Group II: Heparin and no microsieveExperimental Treatment2 Interventions
The needle will be prepped with 500 U heparin USP per 10 mL to coat the inside of the needle. The provider will expel the tissue into formalin
Group III: Heparin and microsieveExperimental Treatment2 Interventions
The needle will be prepped with 500 U heparin USP per 10 mL to coat the inside of the needle. The provider will expel the tissue onto the microsieve
Group IV: No heparina nd no microsieveActive Control2 Interventions
The needle not be prepped. The provider will expel the tissue into formalin

Find a Location

Who is running the clinical trial?

University Hospitals Cleveland Medical CenterLead Sponsor
324 Previous Clinical Trials
342,882 Total Patients Enrolled
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
562 Previous Clinical Trials
144,806 Total Patients Enrolled
Shaffer Mok, MDPrincipal InvestigatorMoffitt Cancer Center

Media Library

wet heparinzed suction Clinical Trial Eligibility Overview. Trial Name: NCT05041335 — N/A
Cancer Research Study Groups: Heparin and microsieve, No heparin and microsieve, No heparina nd no microsieve, Heparin and no microsieve
Cancer Clinical Trial 2023: wet heparinzed suction Highlights & Side Effects. Trial Name: NCT05041335 — N/A
wet heparinzed suction 2023 Treatment Timeline for Medical Study. Trial Name: NCT05041335 — N/A
~28 spots leftby Jan 2025
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