Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique

Endoscopic ultrasound-guided liver biopsy (EUS-LB) can overcome many shortcomings of percutaneous liver biopsy and TJLB. Targeted and non-targeted liver biopsies can be done through this biopsy. It can be done in patients with international normalized ratio (INR) up to 2. It has less tissue fragmentation compared with TJLB.

Needle entering the liver can be viewed in real-time (intrahepatic vessels and bile duct can be spared from injury) (Sharma et al., 2023). Both lobes of the liver can be accessed. It provides minimal patient discomfort. EUS-LB can access liver lesions that may not be safely accessible by routine US or computed tomography (tenBerge et al., 2002). It provides better results in obese individuals compared with percutaneous liver biopsy. It is safe in pregnant females requiring liver biopsy (Khare et al., 2024). Despite these advantages, EUS-LB is largely limited to tertiary care centers and its use is not yet widespread. This may be because, since its inception, numerous variations in needle shape, needle size, and, most notably, sampling techniques have been adopted.

However, no consensus protocol for acquisition has been recognized, leading to poor procedural standardization and wide ranges of reported outcomes in sample quality and diagnostic yield. As such, there is a substantial need for a uniform technique that will safely maximize diagnostic performance with minimal needle passes (Khare et al., 2024).

Study Overview

• Status: Recruiting
• Conditions: Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique
• Intervention / Treatment: Device: Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Elbadry Elrabie, master; Phone Number: 01023941334; Email: elbadrysara615@gmail.com

Study Locations

• Egypt
  • Sohag, Egypt
    • Recruiting
    • Sohag University
    • Contact: Sara Elbadry Elrabie, master; Phone Number: 01147045010

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• The participants of the study were adults in need of liver biopsy for the evaluation of Altered liver function test

Exclusion Criteria:

• Using anti-platelets or anticoagulants within the last 5days
• Inability to provide informed consent
• Moderate-to-gross ascites
• Child C cirrhosis
• INR more than 2.01
• Platelet count less than 50,000/µL3

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique	Device: Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique; Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique	Measurement the efficacy of liver biopsy specimens by European Association for the Study of Liver Disease (EASL) criteria . - Total Specimen Length (TSL) of more than or equal to 15 mile-meters.	-Study period: Duration of the study will be 12 months after acceptance of The Ethical Committee Of The Medical Research. All patients will sign an informed written consent before starting the data collection with respect to patient's confidentiality.

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Study Director: Sara Elbadry Eirabie, master, Sohag

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Soh-Med-24-12---6MD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No