Wet Heparin for Obtaining Liver Tissue for EUS Guided Liver Biopsy

Completed · Not applicable

Conditions studied: Liver Diseases

In brief

Since its inception, endoscopic ultrasound with fine needle aspiration (EUS-FNA) has proven a valuable diagnostic and prognostic tool for evaluating a diverse number of pathologies. One such pathology is chronic liver disease (CLD), for which EUS-guided liver biopsy has become a well-accepted method for tissues acquisition. EUS-LB also been compared with percutaneous and transguluar routes showing at least comparable ability to obtain adequate tissue for CLD. Though enhancements to EUS-FNA, such as dry suction, stylet pull have not proven to demonstrate increased diagnostic accuracy for EUS-FNA, the use of wet suction technique (WEST) has demonstrated the ability to obtain more cellular tissue samples with less blood contamination. In an attempt to obtain further improvement in tissue adequacy, with less blood contamination for EUS-LB, the use of wet heparinized needles will be investigated as compared with conventional EUS-LB for patients with CLD. To do this subjects shall be selected to undergo EUS-LB. As it is the standard to perform 3 needle passes during EUS-LB, subjects will undergo one pass with the following designations: pass 1: conventional EUS-LB \[no flush\], pass 2: dry heparin heparin \[5 milliliters (mL) of heparin flushed and then flushed with air\], and pass 3: wet heparin \[5 milliliters (mL) of heparin flushed and retained in the needle\]. It is predicted that specimens collected with heparinized needle shall show improved adequacy compared with conventional EUS-LB. It is also predicted that the heparin wash will lead to less blood contamination compared with conventional methods. Subjects shall also be monitored for adverse events (AE).

Key facts

Study ID

NCT03103997

Run by

Geisinger Clinic

People needed

40

Starts

2017-01-06

Expected to finish

2018-06-30

Last updated by the study team

2018-08-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients undergoing EUS-LB
• Platelet count > 50,000
• International normalized ratio (INR) < 1.5
• Age > 18 years
• Non-pregnant patients

You may not qualify if…

• Age < 18 years
• Pregnant Patients
• Inability to obtain consent
• Anticoagulants or anti-platelet agents use (excluding aspirin) within the last 7-10 days
• Platelet count < 50,000
• INR > 1.5
• Presence of ascites
• Known liver cirrhosis
• Patients with a heparin or porcine allergy
• Patients with prior heparin induced thrombocytopenia (HIT)
• Patient's with religious aversion to porcine-containing products

Where it is running

• Geisinger Medical Center — Danville, Pennsylvania, United States

Full record on ClinicalTrials.gov

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