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19 Versus 22-Gauge Needle for EUS-LB

NCT02967991 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-11-05

Study results available
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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.

Conditions

Interventions

DEVICE

EUS-guided liver biopsy

Endoscopic ultrasound guided liver biopsy

Sponsors & Collaborators

  • Geisinger Clinic

    lead OTHER

Principal Investigators

  • David L Diehl, M.D. · Geisinger Clinic

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02967991 on ClinicalTrials.gov