Skip to main content
OpenTrials
Completed

NCT Number: NCT04235855

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

NAFLD Alcohol-Induced Disorders Alcohol-Related Disorders Alcoholic Hepatitis Chemically-Induced Disorders Digestive System Diseases Fatty Liver Hepatitis Hepatitis, Alcoholic Liver Diseases Liver Diseases, Alcoholic Non-alcoholic Fatty Liver Disease Substance-Related Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asian Institute of Gastroenterology Hospitals

Hyderabad, Telangana, 500089, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic USG guided Liver biopsy

Device

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 Biopsy

Device

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 outcomes

  1. Diagnostic yield with EUS guided liver biopsy .

    Time frame: 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 outcomes

  1. Safety of procedure

    Time frame: 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 .

  2. Duration of procedure

    Time frame: 30 minutes

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

  3. Size of tissue acquired

    Time frame: 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 .

  4. Number of portal tracts

    Time frame: 3 days

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

  5. Post procedural complications

    Time frame: 3 days

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

  6. NAS score in fatty liver patients

    Time frame: 3 days

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

  7. Patient recovery time

    Time frame: 3 days

    Patient recovery time when compared to per cutaneous liver biopsy procedure .

Sponsors and collaborators

Lead sponsor

Asian Institute of Gastroenterology, India

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 22, 2020
Registry last updated
Jan 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.