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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
40
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.
Center for Interventional Endoscopy
Orlando, Florida, United States
Diagnostic adequacy of the tissue sample
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.
Time frame: 24 hours
Specimen length
Maximum specimen length in millimeters after formalin fixation will be documented.
Time frame: 24 hours
Portal tracts
The total number of complete portal tracts for each biopsy specimen will be documented.
Time frame: 24 hours
Rates of specimen adequacy
Inadequate specimen - defined as biopsy specimens from which a definitive histological diagnosis cannot be rendered by the pathologist.
Time frame: 24 hours
Cross over
The rate of crossover to the other treatment arm will be documented
Time frame: 1 week, 30 days
Procedure duration
The total length of time for the procedure will be documented in minutes.
Time frame: 24 hours
Rate of adverse events
The subject will be asked to report and medical records will be reviewed for any adveerse events related to the procedure.
Time frame: 24 hours, 1 week, 30 days
Procedural costs
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The subject's account will be reviewed for total costs associated with the procedure.
Time frame: 30 days
Pain scores
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.
Time frame: 24 hours, 1 week, 30 days