19Gauge Fine Needle Biopsy (FNB) Versus 22Gauge FNB for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB)

Geisinger Health

Status: Completed

Conditions: Chronic Liver Disease

Treatments: Procedure: 22G FNB; Procedure: 19G FNB

Study type: Interventional

Funder types: Other

Identifiers

NCT04806607

2020-1072

Details and patient eligibility

About

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

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

19Gauge Fine Needle Biopsy

Active Comparator group

Description:

19Gauge Fine Needle

Treatment:

Procedure: 19G FNB

Procedure: 22G FNB

22 Gauge Fine Needle Biopsy

Active Comparator group

Description:

22Gauge Fine Needle

Treatment:

Procedure: 19G FNB

Procedure: 22G FNB