Liver Biopsy
Conditions
Keywords
percutaneous biopsy, endoscopic guided biopsy, liver, hepatic conditions
Brief summary
This study is to evaluate and directly compare the technical success, tissue quality, diagnostic efficacy and safety profile of Percutaneous and Endoscopic Ultrasound-guided Liver Biopsy.
Detailed description
Liver biopsy (LB) is essential for the diagnosis and evaluation of a variety of hepatic conditions, such as grading/staging of chronic liver disease secondary to alcohol, non-alcoholic steatohepatitis, viral hepatitis, hemochromatosis, Wilson's disease, cholestatic liver disease, as well as in elucidating the etiology of elevation in liver tests.1 Since it was first performed in 1883, percutaneous (PC) liver biopsy has become routine practice and is usually performed under the guidance of real-time imaging using transabdominal ultrasound (US) or computed tomography (CT).1,2 However, in recent times, liver biopsy has been increasingly performed via transgastric or transduodenal routes under endoscopic ultrasound (EUS) guidance. The perceived advantages of performing EUS-LB compared to PC-LB are the ability to simultaneously assess other organs such as common bile duct and pancreas, access to both left and right lobes of the liver and the routine use of conscious sedation during EUS procedures.3 Although single arm cohort studies and retrospective comparative studies assessing the technical success, tissue quality and safety of these different liver biopsy modalities exist, currently there are no randomized trials comparing PC and EUS-guided LB.4-7
Interventions
DIAGNOSTIC_TESTbiopsy
Liver biopsy (LB) is essential for the diagnosis and evaluation of a variety of hepatic conditions, such as grading/staging of chronic liver disease secondary to alcohol, non-alcoholic steatohepatitis, viral hepatitis, hemochromatosis, Wilson's disease, cholestatic liver disease, as well as in elucidating the etiology of elevation in liver tests.
Sponsors
AdventHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Caregiver)
Masking description
The pathologist will be blinded to the procedure received by the patient.
Intervention model description
This is a randomized trial comparing two methods for procuring liver biopsy: 1) EUS-guided and 2) percutaneous.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. All patients referred for liver biopsy for any reason 2. Informed consent obtained from the patient 3. ≥ 18 years old 4. Able to undergo conscious sedation for EUS procedure
Exclusion criteria
1. \<18 years old 2. Unable to obtain informed consent from the patient 3. Medically unfit for sedation 4. Pregnant patients 5. Presence of a mass lesion in the liver requiring biopsy visualized on cross-sectional imaging 6. Irreversible coagulopathy as determined by platelet count \< 50,000 mm3 or International Normalized Ratio (INR) \> 1.5 7. Unable to stop anticoagulation or anti-platelet therapy for 5 days prior to the procedure 8. Hemophilia 9. Presence of an alternative etiology for elevated liver tests seen during liver biopsy, e.g. choledocholithiasis discovered during EUS examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic adequacy of the tissue sample | 24 hours | The primary outcome of the randomized trial is to compare between EUS-LB and PC-LB, the rate of procurement of diagnostically adequate specimens, defined as the presence of both maximum specimen length ≥ 25mm AND total no. of complete portal tracts ≥ 11. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Portal tracts | 24 hours | The total number of complete portal tracts for each biopsy specimen will be documented. |
| Rates of specimen adequacy | 24 hours | Inadequate specimen - defined as biopsy specimens from which a definitive histological diagnosis cannot be rendered by the pathologist. |
| Cross over | 1 week, 30 days | The rate of crossover to the other treatment arm will be documented |
| Specimen length | 24 hours | Maximum specimen length in millimeters after formalin fixation will be documented. |
| Rate of adverse events | 24 hours, 1 week, 30 days | The subject will be asked to report and medical records will be reviewed for any adveerse events related to the procedure. |
| Procedural costs | 30 days | The subject's account will be reviewed for total costs associated with the procedure. |
| Pain scores | 24 hours, 1 week, 30 days | Pain scores measured using the Visual Analog Scale (VAS) on a scale of 0 - 10 with 0 representing no pain and 10 representing the worst pain the subject has ever had; before and after biopsy has been performed. |
| Procedure duration | 24 hours | The total length of time for the procedure will be documented in minutes. |
Countries
United States
Outcome results
None listed