NAFLD, Alcoholic Hepatitis
Conditions
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.
Interventions
DEVICEEndoscopic USG guided Liver biopsy
Diagnostic yield with EUS guided liver biopsy - Left lobe Bx vs combined right and left lobe or vs right lobe would be assessed.
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 .
Sponsors
Asian Institute of Gastroenterology, India
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
The biopsy specimens would be reported independently by two pathologists who would be masked to the source of tissue ( right/ left lobe ).
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 . |
| 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) . |
| Duration of procedure | 30 minutes | Time between start and end of the procedure 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 |
| Patient recovery time | 3 days | Patient recovery time when compared to per cutaneous liver biopsy procedure . |
| Post procedural complications | 3 days | Any procedure related complications such as pain (\>6 on VAS) and bleeding would be noted . |
Countries
India
Outcome results
None listed