19 Versus 22-Gauge Fine Needle Biopsy (FNB) Needles for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB): A Prospective Pilot Study

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

Chronic liver disorders (CLD) are a major cause of morbidity and mortality for individuals in the US. Though serologic analysis will often lead to a conclusive diagnosis, liver biopsy remains an important method for helping to determine the etiology and stage of LD. Percutaneous liver biopsy (PLB), transjugular liver biopsy (TLB) and surgical liver biopsy (SLB) are alternative methods for obtaining hepatic tissue. In recent years endoscopic ultrasound guided-liver biopsy (EUS-LB) has come to the forefront as a safe and effective method for obtaining tissue in CLD. There are several studies of the safety of EUS-LB as well as the adequacy of specimens obtained in this fashion. Most studies involve a 19-gauge needle, therefore in this study the investigators hope to compare the tissue yields of a 22-gauge fine needle biopsy (FNB) needle, in comparison to conventional 19-gauge. The investigators predict that 19 and 22 gauge FNB needle will demonstrate similar diagnostic accuracy, with less visible blood artifact. Similarly the investigators predict the safety to be equal.

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: August 2016
Completion Date: July 2017
Participants
Target number of participants: 20
Treatments
Active Comparator: 19 Left
EUS-guided liver biopsy using a19-gauge liver biopsy in the left lobe
Experimental: 22 Left
EUS-guided liver biopsy using a 22-gauge liver biopsy in the left lobe
Active Comparator: 19 Right
EUS-guided liver biopsy using a 19-gauge liver biopsy in the right lobe
Experimental: 22 Right
EUS-guided liver biopsy using a 22-gauge liver biopsy in the right lobe
Sponsors
Leads: Geisinger Clinic

This content was sourced from clinicaltrials.gov