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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-08

Study Completion Date

2020-09-15

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).

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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. .

Conditions

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Liver Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective, randomized, multicenter study

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Arm 1 -modified wet suction

Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction

Group Type OTHER

Core Liver Biopsy

Intervention Type DIAGNOSTIC_TEST

Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.

Arm 2- Slow Pull

Intervention: Procedure Core Liver Biopsy Technique: Slow Pull

Group Type OTHER

Core Liver Biopsy

Intervention Type DIAGNOSTIC_TEST

Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.

Interventions

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Core Liver Biopsy

Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.

Intervention Type DIAGNOSTIC_TEST

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No