Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique

NCT ID: NCT06833619

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2027-01-01

Brief Summary

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).

Conditions

Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique

Group Type: OTHER

Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique

Intervention Type: DEVICE

Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique

Interventions

Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique

Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Sara Elbadry Elrabie

Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara Elbadry Eirabie, master

Role: STUDY_DIRECTOR

Sohag

Locations

Sohag University

Sohag, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Sara Elbadry Elrabie, master

Role: CONTACT

elbadrysara615@gmail.com

01023941334

Facility Contacts

Sara Elbadry Elrabie, master

Role: primary

01147045010

Other Identifiers

Soh-Med-24-12---6MD

Identifier Type: -

Identifier Source: org_study_id