Clinical trial NCT03245580: Benign Liver Optimal Core Study (Tissue Acquisition Comparison in Benign Liver Disease)
Official title: Comparison of 2 Techniques Using EUS Guided Liver Biopsies Via 19g CORE Biopsy Needle to Obtain Optimal Core Liver Biopsies in Benign Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Diseases
Lead sponsor: Parkview Health
Sponsor class: OTHER
First posted: 2017-08-10
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized, multicenter study
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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. .

Eligibility 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

Primary outcomes:
measure: Pathological Yield Fragmentation
timeFrame: At day 7 post biopsy
measure: Pathological Yield Length
timeFrame: At time of completion of pathology report
measure: Pathological Yield Quantity
timeFrame: At time of completion of pathology report
Secondary outcomes:
measure: Complications
timeFrame: Complications occurring at time of consent, at procedure time and at day 7 post procedure
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University South Alabama
state: Alabama
city: San Jose
country: United States
facility: Santa CLara Valley Medical Center
state: California
city: Fort Wayne
country: United States
facility: Parkview Regional Medical Center
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: New Orleans
country: United States
facility: Oschner Health System
state: Louisiana
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: Baylor Medical Center
state: Texas
Study officials:
affiliation: parkview cancer institute
name: Neil R Sharma, MD
role: PRINCIPAL_INVESTIGATOR
References: