Wet Heparinized Suction: A Novel Technique to Enhance Tissue Acquisition for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB): A Prospective Trial

Status: Completed
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: Accepts Healthy Volunteers
View:

• Patients undergoing EUS-LB

• Platelet count > 50,000

• International normalized ratio (INR) < 1.5

• Age > 18 years

• Non-pregnant patients

Locations
United States
Pennsylvania
Geisinger Medical Center
Danville
Time Frame
Start Date: January 6, 2017
Completion Date: June 30, 2018
Participants
Target number of participants: 40
Treatments
Active Comparator: New Needle
EUS-guided liver biopsy with needle and suction, no preparation
Experimental: Dry Heparin
EUS-guided liver biopsy with needle flushed with heparin, then flushed with air, suction then attached
Experimental: Wet Heparin
EUS-guided liver biopsy with needle flushed with heparin, 2 cc of liquid added to suction then attached.
Sponsors
Leads: Geisinger Clinic

This content was sourced from clinicaltrials.gov

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