Anticoagulant Flush for Abdominal Cancer

(EUS Heparin Trial)

Recruiting at 1 trial location

Overseen By Shaffer Mok, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University Hospitals Cleveland Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this research is to compare the amount and quality of tissue obtained by EUS-FNB when the device is flushed with an anticoagulant or "blood thinner" vs. saline a salt water solution as well as the use of a microsieve in order for the doctor to look at the tissue to check the acceptability of the specimens before sending for analysis. You will be randomly assigned (like a flip of a coin) to have either the blood thinner or the salt water solution placed within the needle being used to sample your abdominal tumor and to have either a sieve used or not. You will be one of 42 participants enrolled in this data collection study which includes 1 sites in the United States.

Research Team

Shaffer Mok, MD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Your blood platelet count is higher than 50,000.

I had a biopsy for a pancreatic mass but didn't get a clear diagnosis.

I have a solid mass in my abdomen confirmed by imaging and am scheduled for an EUS exam.

Exclusion Criteria

You are allergic to heparin or pork.

You have had a serious reaction to heparin in the past.

Your blood clotting test shows that your blood is not clotting normally.

Treatment Details

Interventions

• Microsieve (Procedure)
• No heparin flush (Procedure)
• No microsieve (Procedure)
• wet heparinzed suction (Procedure)

Trial Overview 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.

Participant Groups

Group I: No heparin and microsieve Experimental Treatment 2 Interventions

The needle not be prepped. The provider will expel the tissue onto the microsieve

Group II: Heparin and no microsieve Experimental Treatment 2 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 microsieve Experimental Treatment 2 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 microsieve Active Control 2 Interventions

The needle not be prepped. The provider will expel the tissue into formalin

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+