EUS-guided Versus Percutaneous Ultrasound-guided Biopsy for Parenchymal Liver Disease

NCT06047327 | Completed

• 1 other identifier: ILBS-EUS-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Liver biopsy may be indicated in various clinical scenarios to help diagnose and manage liver diseases. Endoscopic ultrasound (EUS) liver biopsy and percutaneous USG guided liver biopsy are two methods used to obtain liver tissue samples. EUS involves using an endoscope with an ultrasound probe to guide a needle through the stomach wall and into the liver, while percutaneous ultrasound guided biopsy involves inserting a needle directly through the skin and into the liver using ultrasound guidance. A specimen measuring 15 mm or more and containing 6 to 8 CPTs is generally considered adequate for the histologic diagnosis of diffuse liver disease. However, stricter requirements of specimen length of 20 mm or longer with 11 or more CPTs for reliable grading and staging of chronic viral hepatitis have been recommended. With this study we aim to study in a head-to-head comparison between EUS-guided and percutaneous (PC) liver biopsies, with regards to tissue acquisition adequacy.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Specimen adequacy defined by total specimen length (TSL) ≥ 15 mm and ≥ 8 complete portal triads (CPTs)

  Day 0

Secondary Outcomes (11)

• Post-procedure pain measured on Visual Analogue Scale from (Minimum: 0, Max:10)

  4 hours

• Pre-fix longest intact specimen length.

  3 days

• Pre-fix aggregate specimen length.

  3 days

• Total specimen complete portal tracts (CPTs).

  3 days

• Proportion of specimens >20mm in aggregate length.

  3 days

Study Arms (2)

EUS Guided Liver Biopsy

EXPERIMENTAL

Procedure will be done by 19G Franseen needle in EUS guided liver biopsy.

Diagnostic Test: EUS guided liver biopsy

Percutaneous Liver Biopsy

ACTIVE COMPARATOR

Procedure will be done by 18G BioPince Needle in percutaneous liver biopsy.

Diagnostic Test: Percutaneous Liver Biopsy

Interventions

Percutaneous Liver Biopsy DIAGNOSTIC_TEST

procedure will be done by 18G BioPince Needle

Percutaneous Liver Biopsy

EUS guided liver biopsy DIAGNOSTIC_TEST

Procedure will be performed by 19G Franseen needle.

EUS Guided Liver Biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> 18 years of age.
• Eligibility for deep sedation with propofol.
• Undergoing liver biopsy for diagnosis/evaluation/staging.

You may not qualify if:

• Coagulopathy, defined by platelet count \< 70,000/mL and/or INR \> 1.7.
• Inability to discontinue anticoagulation or antiplatelet agents for 5 days prior to the procedure.
• Presence of unrelieved biliary obstruction.
• Presence of ascites.
• Suspected or known hepatic malignancy.
• Hypertensive patients with uncontrolled blood pressure. (SBP \>150 and/or DBP\>100mmHg)
• Medically unfit for sedation.
• Inability to provide informed consent.
• Cannot understand Hindi or English should be excluded since they will not be able to reply objectively to questionnaire.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institiute of liver and biliary sciences

New Delhi, 110070, India

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 21, 2023
• Study Start: November 1, 2023
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)