Anticoagulant Flush for Abdominal Cancer

(EUS Heparin Trial)

Recruiting at 1 trial location

Overseen By Shaffer Mok, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Hospitals Cleveland Medical Center

Must not be taking: Anticoagulants, Anti-platelet agents

Disqualifiers: Pregnancy, Cystic masses, Heparin allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

42 Participants Needed

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking anticoagulants or anti-platelet agents (except aspirin) at least 7-10 days before participating.

What data supports the effectiveness of the treatment Microsieve, No heparin flush, No microsieve, wet heparinized suction for abdominal cancer?

Research shows that anticoagulants like low molecular weight heparin (LMWH) are effective in preventing blood clots and may also have anti-cancer effects, reducing mortality in cancer patients. This suggests that using anticoagulant treatments during abdominal cancer surgery could be beneficial. ^{1 2 3 4 5}

Is the anticoagulant flush safe for humans?

Heparin flushes, often used to keep catheters open, can cause serious complications like bleeding and a condition called heparin-induced thrombocytopenia and thrombosis syndrome (HITS). While some studies suggest that using saline instead of heparin can be just as effective for preventing clots, heparin flushes are not always harmless and can lead to significant side effects. ^{1 6 7 8 9}

How is the treatment 'wet heparinized suction' unique for abdominal cancer?

The 'wet heparinized suction' treatment is unique because it involves using heparin (a blood thinner) in a suction method, which may help prevent blood clots during abdominal cancer surgery. This approach is different from standard anticoagulant treatments that are typically administered through injections or orally. ^{1 5 10 11 12}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo EUS-FNB with either heparin or saline solution and use of a microsieve or not, to compare tissue acquisition techniques

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

4 weeks

Treatment Details

Interventions

• Microsieve
• No heparin flush
• No microsieve
• wet heparinzed suction

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+

Findings from Research

In a study involving 614 patients undergoing colorectal cancer surgery, extended duration thromboprophylaxis with tinzaparin did not significantly improve disease-free survival compared to standard in-hospital thromboprophylaxis, with similar outcomes observed in both groups.

The rates of venous thromboembolism and major bleeding complications were low and comparable between the extended duration and in-hospital groups, indicating that both approaches are safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of extended duration to perioperative thromboprophylaxis with low molecular weight heparin on disease-free survival after surgical resection of colorectal cancer (PERIOP-01): multicentre, open label, randomised controlled trial. Auer, RC., Ott, M., Karanicolas, P., et al.[2022]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Venous thromboembolism in abdominal cancer surgery. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of extended duration to perioperative thromboprophylaxis with low molecular weight heparin on disease-free survival after surgical resection of colorectal cancer (PERIOP-01): multicentre, open label, randomised controlled trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Prophylaxis extension for venous thromboembolism after major abdominal and pelvic surgery for cancer (prevent): Quality improvement transitioned into a cohort study. [2022]

4. Greece pubmed.ncbi.nlm.nih.gov

Perioperative heparin-therapy inhibits late death from metastatic cancer. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Thromboprophylaxis following surgery for colorectal cancer - is it worthwhile after hospital discharge? [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Impact of decreased heparin dose for flush-lock of implanted venous access ports in pediatric oncology patients. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Normal saline versus heparin flush for maintaining central venous catheter patency during apheresis collection of peripheral blood stem cells (PBSC). [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Effect of Heparinized Flush Concentration on Safety and Efficacy During Endovascular Thrombectomy for Acute Ischemic Stroke: Results from the MR CLEAN Registry. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

The heparin flush syndrome: a cause of iatrogenic hemorrhage. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Low-molecular-weight heparin for the prevention of postoperative venous thromboembolism after abdominal surgery: a review. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Postoperative Evaluation and Management of Portomesenteric Venous Thrombosis in Patients With IBD. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Prophylactic Low-Molecular Weight Heparin for Ambulatory Patients With Advanced Pancreatic Cancer: Outcomes From the CONKO-004 Trial. [2022]