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



Status:Enrolling by invitation
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:1/20/2019
Start Date:March 8, 2018
End Date:December 2019

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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

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. We will also note technical
success rate (ability to insert the needle twice into the liver for obtaining 2 specimens and
ability to pass into the right and left lobe of the liver).

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
We found this trial at
3
sites
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Danville, PA
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Fort Wayne, Indiana 46845
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Fort Wayne, IN
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