Anticoagulant Flush for Abdominal Cancer

(EUS Heparin Trial)

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests methods to improve tissue collection from abdominal tumors, aiming to make diagnosis easier and more accurate. It compares using a blood thinner (wet heparinized suction) versus a salt-water solution in the sampling needle and examines whether a small sieve can immediately check tissue quality. Individuals with a solid abdominal mass shown on a scan and scheduled for a specific type of biopsy (EUS) might be eligible to join. As an unphased trial, this study offers a unique opportunity to advance diagnostic techniques for abdominal tumors.

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 prior data suggests that this protocol is safe for participants?

Research shows that using wet heparinized suction, which involves flushing the needle with the blood thinner heparin, is generally safe for diagnosing pancreatic tumors. Studies have found it effective and well-tolerated, meaning patients usually don't experience negative reactions. One study found that heparin can improve the quality of tissue samples taken from the body.

Specific safety data for the microsieve is not available, but it is used to check tissue quality before analysis. As a tool rather than a treatment, it is unlikely to cause harm.

In this trial, participants will have the needle prepared with or without heparin, and the tissue will be placed on a microsieve or into a solution. This setup aims to ensure safety while obtaining the best tissue samples for analysis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different ways of using heparin can improve procedures for abdominal cancer. Unlike standard practice, which may not use anticoagulants during tissue collection, this trial examines if coating needles with heparin can reduce blood clotting and improve sample quality. Additionally, the trial looks at using a microsieve to handle tissue samples more effectively. These approaches might lead to better diagnostic accuracy and less invasive procedures for patients.

What evidence suggests that this trial's treatments could be effective for abdominal cancer?

Research has shown that using a heparin flush, a type of blood thinner, can improve the quality of tissue samples taken from abdominal tumors. One study found that this method can increase the success rate of sampling. In this trial, some participants will receive a heparin flush with or without the use of a microsieve. When examining pancreatic lesions, these needles have demonstrated up to 94.7% accuracy in diagnosis. This suggests that using heparin might help doctors obtain better samples for diagnosing and treating abdominal cancer. Although evidence for the microsieve is less direct, it may help doctors examine tissue samples more effectively. Participants in other arms of this trial will not receive a heparin flush, with or without the use of a microsieve, to compare the effectiveness of these methods. ^{1 2 4 6 7}

Who Is on the Research Team?

Shaffer Mok, MD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinconnect.io clinconnect.io/trials/NCT05041335

Wet Heparinized Suction for Abdominal Cancer - ClinConnect 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 ...

2. ancora.ai ancora.ai/en/details/NCT05041335

Wet Heparinized Suction for Abdominal Cancer 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10268349/

Effect of wet-heparinized suction on the quality ... Wet-heparinized suction can improve the quality of mediastinal lesion samples obtained by EUS-FNA and increase the success rate of sampling.

4. npcf.us npcf.us/clinical-trials/wet-heparinized-suction-for-abdominal-cancer/

Wet Heparinized Suction For Abdominal Cancer When evaluating pancreatic lesions, FNB needles have demonstrated 81-100% technical success and up to 94.7% diagnostic accuracy [18-21]. Overall, EUS-FNB ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10018294/

Tissue Quality Comparison Between Heparinized Wet ... Third, heparin wet-suction showed a non-significant trend of better outcome in the subgroups of small tumor (<2 cm), trans-duodenal route, and resectable ...

6. gutnliver.org gutnliver.org/journal/view.html?volume=17&number=2&spage=318

Tissue Quality Comparison Between Heparinized Wet ... Heparinized wet-suction was proved to be safe and efficient for the diagnosis of pancreatic solid tumors. This study also demonstrated that ...

7. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)36657-8/fulltext

Comparing normal saline versus diluted heparin to lock ... We randomly allocated 802 cancer patients with a newly inserted port either to heparin lock (300 U/3 ml) or to NS lock groups in a 1:1 assignment ratio.