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

Not Applicable

Completed

• Conditions: Alcoholic Hepatitis; NAFLD
• Interventions: Device: Endoscopic USG guided Liver biopsy; Device: Percutaneous Liver Biopsy

• Registration Number: NCT04235855
• Lead Sponsor: Asian Institute of Gastroenterology, India

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2019-10-31
• Study First Submitted: 2020-01-16
• Study First Submitted QC: 2020-01-18
• Study First Posted: 2020-01-22
• Status Verified: 2022-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01
• Last Update Submitted: 2022-01-03
• Last Update Posted: 2022-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endoscopic USG guided Liver biopsy	Endoscopic USG guided Liver biopsy	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.
Percutaneous Liver biopsy	Percutaneous Liver Biopsy	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 .

Primary Outcome Measures

Name	Time	Method
Diagnostic yield with EUS guided liver biopsy .	3 days	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 .

Secondary Outcome Measures

Name	Time	Method
Safety of procedure	3 days	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 .
Post procedural complications	3 days	Any procedure related complications such as pain (\>6 on VAS) and bleeding would be noted .
NAS score in fatty liver patients	3 days	Difference in NAS score between right lobe and right vs left lobe in fatty liver patients
Duration of procedure	30 minutes	Time between start and end of the procedure would be noted .
Size of tissue acquired	3 days	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 .
Number of portal tracts	3 days	The adequacy of the sample would be assessed as per the AASLD and Royal College of Pathology definition (CPTs 11) .
Patient recovery time	3 days	Patient recovery time when compared to per cutaneous liver biopsy procedure .

Trial Locations

Locations (1)

Asian Institute of Gastroenterology Hospitals; 🇮🇳 Hyderabad, Telangana, India