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

Study Overview
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Brief Summary
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Liver biopsy would be done by Endoscopic Ultrasound using Acquire needle.

Detailed Description
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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.

Official Title
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EUS Guided Liver Biopsy Proposal Titled : EUS Guided Liver Biopsy - Will it Give Better Yield , More Tissue With Less Complication ?

Conditions
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NAFLD, Alcoholic Hepatitis

Intervention / Treatment
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* Device: Endoscopic USG guided Liver biopsy
* Device: Percutaneous Liver Biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscopic USG guided Liver biopsy<br>Olympus linear echo endoscope (GF -UCT 180, Olympus Ltde, Tkyo, Japan) will be used. 19 Gz EUS Acquire needle Boston ©Scientific Corp will be used for liver tissue acquisition. | Device: Endoscopic USG guided Liver biopsy<br>* Diagnostic yield with EUS guided liver biopsy - Left lobe Bx vs combined right and left lobe or vs right lobe would be assessed.<br>|
| Active Comparator: Percutaneous Liver biopsy<br>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 . | Device: Percutaneous Liver Biopsy<br>* 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 .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 . | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 . | 3 days | 
| Duration of procedure | Time between start and end of the procedure would be noted . | 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 . | 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) . | 3 days | 
| Post procedural complications | Any procedure related complications such as pain (>6 on VAS) and bleeding would be noted . | 3 days | 
| NAS score in fatty liver patients | Difference in NAS score between right lobe and right vs left lobe in fatty liver patients | 3 days | 
| Patient recovery time | Patient recovery time when compared to per cutaneous liver biopsy procedure . | 3 days |