EUS Guided Liver Biopsy - Will it Give Better Yield, More Tissue With Less Complication?

Asian Institute of Gastroenterology, India50 enrolled

Overview

Liver biopsy would be done by Endoscopic Ultrasound using Acquire needle.

In this study, we aim to evaluate the tissue adequacy of EUS guided liver biopsy for parenchymal liver disease and to evaluate if diagnostic yield of left lobe is non-inferior to right lobe biopsies and to assess if combination biopsies have better yield than single lobe biopsies. Safety of the procedure and technical success would be noted. The data would be analysed using SPSS software and needful variables and tests would be used as per statistical requirement.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

NAFLD Alcoholic Hepatitis

Interventions

Endoscopic USG guided Liver biopsyDEVICE

Diagnostic yield with EUS guided liver biopsy - Left lobe Bx vs combined right and left lobe or vs right lobe would be assessed.

Percutaneous Liver BiopsyDEVICE

All liver biopsies done in the Institute as routine procedure by percutaneous route would be compared with the EUS guided biopsy in respect to safety , tissue quality and diagnostic yield .

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients of any undiagnosed hepatic disease (after extensive investigation - serological as well as imaging) requiring a liver biopsy * Patients of NAFLD who need liver biopsy * Alcoholic hepatitis patients needing biopsy * Any patient with unexplained transaminesemia \> 1.5 times ULN needing a liver biopsy as advised by Hepatologist Exclusion Criteria: * Any liver Space occupying lesion suspicious of malignancy * Platelet count \<80,000 * INR \> 1.5 * Pregnancy * Severe cardiovascular and pulmonary diseases * Recent use of anti-platelet agents within 5 days of the procedure * Unwilling to provide informed consent

Locations (1)

Asian Institute of Gastroenterology Hospitals

Hyderabad, Telangana, India

Outcomes

Primary Outcomes

Diagnostic yield with EUS guided liver biopsy .

The diagnostic yield of a right lobe biopsy and left lobe biopsy would be compared to see if right lobe biopsy gives any additional information for diagnosis when compared to left lobe .

Time frame: 3 days

Secondary Outcomes

Safety of procedure

Sedation related adverse effect will be monitored as per the institute protocol . Any type of bleed during procedure or needing additional intervention would be recorded as a major adverse effect .

Time frame: 3 days

Duration of procedure

Time between start and end of the procedure would be noted .

Time frame: 30 minutes

Size of tissue acquired

The length of the biopsy tissue would be ascertained immediately by onsite pathologist and would be assessed as per the AASLD and Royal College of Pathology definition .

Time frame: 3 days

Number of portal tracts

The adequacy of the sample would be assessed as per the AASLD and Royal College of Pathology definition (CPTs 11) .

Time frame: 3 days

Post procedural complications

Any procedure related complications such as pain (\>6 on VAS) and bleeding would be noted .

Time frame: 3 days

NAS score in fatty liver patients

Difference in NAS score between right lobe and right vs left lobe in fatty liver patients

Time frame: 3 days

Data from ClinicalTrials.gov

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