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

Not Applicable

Completed

• Conditions: Liver Diseases
• Interventions: Diagnostic Test: Core Liver Biopsy

• Registration Number: NCT03245580
• Lead Sponsor: Parkview Health

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. .

Study Timeline

• Study First Submitted: 2017-07-17
• Study First Submitted QC: 2017-08-09
• Study First Posted: 2017-08-10
• Study Start: 2018-03-08
• Primary Completion: 2020-09-15
• Study Completion: 2020-09-15
• Results First Submitted: 2021-12-17
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-15
• Last Update Submitted: 2022-03-15
• Results First Posted: 2022-04-07
• Last Update Posted: 2022-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1 -modified wet suction	Core Liver Biopsy	Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction
Arm 2- Slow Pull	Core Liver Biopsy	Intervention: Procedure Core Liver Biopsy Technique: Slow Pull

Primary Outcome Measures

Name	Time	Method
Pathological Yield Quantity	At time of completion of pathology report	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.
Pathological Yield Fragmentation	At day 7 post biopsy	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.
Pathological Yield Length	At time of completion of pathology report	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.

Secondary Outcome Measures

Name	Time	Method
Complications	Complications occurring at time of consent, at procedure time and at day 7 post procedure	Tracking any complications that may be associated with each technique. Complications will be assessed and tracked following CTCAE V4.

Trial Locations

Locations (7)

University South Alabama; 🇺🇸 Mobile, Alabama, United States

Parkview Regional Medical Center; 🇺🇸 Fort Wayne, Indiana, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States

Baylor Medical Center; 🇺🇸 Houston, Texas, United States

Oschner Health System; 🇺🇸 New Orleans, Louisiana, United States

Santa CLara Valley Medical Center; 🇺🇸 San Jose, California, United States