Skip to main content
MedPathMedPath Home
Clinical Trials/NCT04806607
NCT04806607
Completed
Not Applicable

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

Geisinger Clinic1 site in 1 country42 target enrollmentApril 30, 2021
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsChronic Liver Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Liver Disease
Sponsor
Geisinger Clinic
Enrollment
42
Locations
1
Primary Endpoint
Length of Longest Piece
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

To determine the adequacy of EUS-LB using a 19G core needle compared to a 22G core needle in a prospective randomized study.

Detailed Description

The 19Gauge core and 22Gauge core needles have both been used for EUS-LB with good success. Previous studies have reported good safety and tissue adequacy with both the needles, but the head-on comparison between these two needles is lacking. This is a prospective randomized trial comparing the biopsy specimen adequacy of 19Gauge versus 22Gauge core needles for EUS-LB.

Registry
clinicaltrials.gov
Start Date
April 30, 2021
End Date
March 16, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David L. Diehl

Principal Investigator

Geisinger Clinic

Eligibility Criteria

Inclusion Criteria

  • •Patients undergoing EUS-LB
  • •Platelet Count \> 50,000
  • •International normalized ratio (INR) \< 1.5
  • •Age \> 18 years of age
  • •Non-Pregnant Patients

Exclusion Criteria

  • •Age \< 18 Years of Age
  • •Pregnant Patients
  • •Inability to obtain consent
  • •Anticoagulants or anti-platelet agents (excluding aspirin) within the last 7 -10 days
  • •Platelet count \< 50,000
  • •Presence of Ascites
  • •Known Liver Cirrhosis

Outcomes

Primary Outcomes

Length of Longest Piece

Time Frame: Up to 5 Days

Length of the longest piece of the liver tissue obtained

Secondary Outcomes

  • Adverse Events and Serious Adverse Events(7 to 10 Days Post Procedure)
  • Aggregate Specimen Length(3 to 5 Days)
  • Degree of Fragmentation(3 to 5 Days)
  • Number of Portal Tracts in the Specimen(3 to 5 Days)

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
EUS GUIDED Transduodenal Biopsy Using the 19G FlexAbdominal Neoplasms
NCT02307253Catholic University of the Sacred Heart246
Completed
Not Applicable
Comparison of 22-gauge and 19-gauge Aspiration Needle During EBUS-TBNALung Cancer
NCT02813603University Hospital, Essen100
Unknown
Not Applicable
Comparing of a 22G EUS Procore Fine Needle Biopsy Device and a 20G EUS Procore Fine Needle Biopsy DevicePancreas Neoplasms
NCT03803930Huazhong University of Science and Technology1,224
Completed
Phase 3
Evaluation of the new 22-gauge EUS guided Biopsy Needle (Acqiure) Comparing to another new 20-gauge FNA needle with forward-cutting bevel (ProCore) in Patients With Autoimmune Pancreatitis : A Prospective Randomized, Controlled Multicenter Studytype 1 autoimmune pancreatitis
JPRN-UMIN000027668Bilio-Pancreatic Stenting study group110
Completed
Not Applicable
Evaluation of 19-gauge vs 21-gauge EBUS TBNA in Assessing Thoracic LymphadenopathyEnlarged Lymph Nodes (Excluding Infective)
NCT03657849HealthPartners Institute60