Benign Liver Optimal Core Study (Tissue Acquisition Comparison in Benign Liver Disease)

Study Overview
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Brief Summary
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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).

Detailed Description
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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. .

Official Title
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Comparison of 2 Techniques Using EUS Guided Liver Biopsies Via 19g CORE Biopsy Needle to Obtain Optimal Core Liver Biopsies in Benign Disease

Conditions
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Liver Diseases

Intervention / Treatment
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* Diagnostic Test: Core Liver Biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects that plan to undergo a liver biopsy via EUS to confirm possible underlying liver disease or to determine stage, grade and presence of fibrosis for suspected benign etiology. History of abnormal LFTs Documented history of chronic liver disease Question of underlying liver disease as cause of abnormal imaging or symptoms which may be attributed to liver disorder Fatty liver disease Subjects 18 years of age or older Subject must be able to hold anticoagulants as per institutional standard of care Subjects must be deemed physically able to undergo anesthesia. This includes either Monitored Anesthesia Care (MAC) or general anesthesia. Subjects (or the subjects Legally Authorized Representative [LAR]) that have agreed to participate in the study and have signed Informed Consent Women of child bearing potential who are not pregnant as proven by a negative pregnancy test may be included. Exclusion Criteria Subjects that are unable to tolerate anesthesia for the procedure Subjects 17 or under Subjects whose anticoagulants cannot be held Subjects who cannot have or refuse EUS guided procedure Subjects who are pregnant INR >1.5 Platelets 50,000 or less Subjects requiring control of bleeding on initial upper endoscopy Subjects requiring endoscopic mucosal resection Subjects with large volume ascites Subjects requiring pancreatic biopsies

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, randomized, multicenter study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1 -modified wet suction<br>Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction | Diagnostic Test: Core Liver Biopsy<br>* Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.<br>|
| Other: Arm 2- Slow Pull<br>Intervention: Procedure Core Liver Biopsy Technique: Slow Pull | Diagnostic Test: Core Liver Biopsy<br>* Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | At time of completion of pathology report | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Tracking any complications that may be associated with each technique. Complications will be assessed and tracked following CTCAE V4. | Complications occurring at time of consent, at procedure time and at day 7 post procedure |