The primary purpose of this prospective, randomized, multicenter study is to evaluate and compare the amount and quality of tissue samples yielded in a liver biopsy comparing 2 different techniques of EUS guided CORE liver biopsy for benign disease. The two techniques: "modified Wet suction" and "Slow pull" technique of collecting tissue from a liver biopsy via Endoscopic Ultrasound (EUS).
Each subject will have a biopsy performed via one of 2 different techniques: "modified wet suction", or "slow pull" technique. A randomization process will determine which technique. Each subject shall undergo 2 passes (2 cores of tissue will be obtained - ideally from the right and left lobe of the liver. Quality of tissue obtained via the 2 different techniques will be evaluated by number of fragments, length of specimens and number of tracts observed by the local pathologist and compared between the tissues obtained from the two techniques. .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
153
Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.
University South Alabama
Mobile, Alabama, United States
Santa CLara Valley Medical Center
San Jose, California, United States
Parkview Regional Medical Center
Fort Wayne, Indiana, United States
Indiana University
Indianapolis, Indiana, United States
Pathological Yield Fragmentation
To determine if there is a significant difference in pathological yield as determined by fragmentation of portal tracts of the biopsy sample between a "modified wet suction," and "slow pull" techniques in obtaining CORE of histologic tissue. Pathological yield will be measured by assessment of portal tracts fragmentation by designated pathologists with experience in liver biopsy specimens.
Time frame: At day 7 post biopsy
Pathological Yield Length
To determine if there is a significant difference in pathological yield as determined by length of portal tracts of the biopsy sample between a "modified wet suction," and "slow pull" techniques in obtaining CORE of histologic tissue. Length of portal tracts will be measured in mm by designated pathologists with experience in liver biopsy assessment techniques.
Time frame: At time of completion of pathology report
Pathological Yield Quantity
To determine if there is a significant difference in pathological yield as determined by number of portal tracts of the biopsy sample between a "modified wet suction," and "slow pull" techniques in obtaining CORE of histologic tissue. The number of portal tracts will be assesses and tallied by designated pathologists with experience in the assessment of liver biopsies.
Time frame: At time of completion of pathology report
Complications
Tracking any complications that may be associated with each technique. Complications will be assessed and tracked following CTCAE V4.
Time frame: Complications occurring at time of consent, at procedure time and at day 7 post procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Oschner Health System
New Orleans, Louisiana, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Baylor Medical Center
Houston, Texas, United States