← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately after the intervention/procedure/surgery

Awards & highlights

EUS Heparin Trial 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.Check my eligibility

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.See study design

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.

EUS Heparin Trial 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.

EUS Heparin Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after the intervention/procedure/surgery

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Aggregate specimen length (ASL)

Secondary outcome measures

Adequacy of diagnosis

Histology adequacy score

Length of the longest piece (LLP)

+6 more

EUS Heparin 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Hospitals Cleveland Medical CenterLead Sponsor

317 Previous Clinical Trials

340,215 Total Patients Enrolled

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

542 Previous Clinical Trials

135,450 Total Patients Enrolled

Shaffer Mok, MDPrincipal InvestigatorMoffitt Cancer Center

Media Library

wet heparinzed suction Clinical Trial Eligibility Overview. Trial Name: NCT05041335 — N/A

Esophageal Cancer Research Study Groups: Heparin and microsieve, No heparin and microsieve, No heparina nd no microsieve, Heparin and no microsieve

Esophageal 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

Frequently Asked Questions

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

Is this experiment seeking out more participants?

"Clinicaltrials.gov indicates that this research trial is not presently in need of participants, despite being published on December 15th 2022 and last updated August 10th 2022. Currently, however, there are 1,956 other studies actively recruiting patients."

Answered by AI

Recent research and studies

Gastrointestinal EndoscopyJournal

“wet Suction Technique (WEST)

Attam, Rajeev, Mustafa A. Arain, Stephen J. Bloechl, Guru Trikudanathan, Satish Munigala, Yan Bakman, Maharaj Singh, et al.. 2015. ““wet Suction Technique (WEST)”: A Novel Way to Enhance the Quality of EUS-FNA Aspirate. Results of a Prospective, Single-blind, Randomized, Controlled Trial Using a 22-gauge Needle for EUS-FNA of Solid Lesions”. Gastrointestinal Endoscopy. Elsevier BV. doi:10.1016/j.gie.2014.11.023.

The American Journal of GastroenterologyJournal

Efficacy, Safety and Predictive Factors for a Positive Yield of Eus-guided Trucut Biopsy: A Large Tertiary Referral Center Experience

Thomas, Titus, Phillip V Kaye, Krish Ragunath, and Guruprasad Aithal. 2009. “Efficacy, Safety and Predictive Factors for a Positive Yield of Eus-guided Trucut Biopsy: A Large Tertiary Referral Center Experience”. The American Journal of Gastroenterology. Ovid Technologies (Wolters Kluwer Health). doi:10.1038/ajg.2008.97.

CytopathologyJournal

The Presence of a Cytopathologist Increases the Diagnostic Accuracy of Endoscopic Ultrasound-guided Fine Needle Aspiration Cytology for Pancreatic Adenocarcinoma: A Meta-analysis

Hébert-Magee, S., S. Bae, S. Varadarajulu, J. Ramesh, A. R. Frost, M. A. Eloubeidi, and I. A. Eltoum. 2013. “The Presence of a Cytopathologist Increases the Diagnostic Accuracy of Endoscopic Ultrasound-guided Fine Needle Aspiration Cytology for Pancreatic Adenocarcinoma: A Meta-analysis”. Cytopathology. Wiley. doi:10.1111/cyt.12071.

American Journal of Clinical PathologyJournal