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

Parkview Health

Status: Completed

Conditions: Liver Diseases

Treatments: Diagnostic Test: Core Liver Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT03245580

PRC17-0714

Details and patient eligibility

About

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).

Full description

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. .

Enrollment: 153 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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153 participants in 2 patient groups

Arm 1 -modified wet suction

Other group

Description:

Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction

Treatment:

Diagnostic Test: Core Liver Biopsy

Arm 2- Slow Pull

Other group

Description:

Intervention: Procedure Core Liver Biopsy Technique: Slow Pull

Treatment:

Diagnostic Test: Core Liver Biopsy