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

Chronic Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04806607
• Other study ID #: 2020-1072
• Status: Completed
• Phase: N/A
• Start date: April 30, 2021
• Est. completion date: March 16, 2022

Study information

• Verified date: April 2022
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 16, 2022
• Est. primary completion date: March 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Liver Disease
• Liver Diseases

Intervention

Procedure:
• 19G FNB
Biopsy specimen adequacy using the 19G FNB
• 22G FNB
Biopsy specimen adequacy using the 22G FNB.

Locations

Country	Name	City	State
United States	Geisinger Medical Center	Danville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Geisinger Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of Longest Piece	Length of the longest piece of the liver tissue obtained	Up to 5 Days
Secondary	Aggregate Specimen Length	Cumulative length of all the pieces of tissue obtained	3 to 5 Days
Secondary	Degree of Fragmentation	Size of the fragments of the samples will be measured, then classified as small (<5 mm), medium (5-8 mm) or large (>8 mm), then compared for the 2 needles	3 to 5 Days
Secondary	Number of Portal Tracts in the Specimen	Number of portal triads will be counted in the specimens and compared for the 2 needles	3 to 5 Days
Secondary	Adverse Events and Serious Adverse Events	Untoward, undesired, or unplanned event	7 to 10 Days Post Procedure