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

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).

Study Overview

• Status: Completed
• Conditions: Liver Diseases
• Intervention / Treatment: Diagnostic test: Core Liver Biopsy

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 Type: Interventional
• Enrollment (Actual): 153
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • University South Alabama
  • California
    • San Jose, California, United States, 95128
      • Santa Clara Valley Medical Center
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Parkview Regional Medical Center
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Oschner Health System
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm 1 -modified wet suction; Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction	Diagnostic test: Core Liver Biopsy; Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.
Other: Arm 2- Slow Pull; Intervention: Procedure Core Liver Biopsy Technique: Slow Pull	Diagnostic test: Core Liver Biopsy; Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological Yield Fragmentation	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.	At day 7 post biopsy
Pathological Yield Length	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.	At time of completion of pathology report
Pathological Yield Quantity	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.	At time of completion of pathology report

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Parkview Health
• Investigators: Principal Investigator: Neil R Sharma, MD, Parkview Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2018
• Primary Completion (Actual): September 15, 2020
• Study Completion (Actual): September 15, 2020

Study Registration Dates

• First Submitted: July 17, 2017
• First Submitted That Met QC Criteria: August 9, 2017
• First Posted (Actual): August 10, 2017

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: PRC17-0714

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes