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

Primary Purpose

Liver Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Core Liver Biopsy
Sponsored by
Parkview Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University South Alabama
  • Santa CLara Valley Medical Center
  • Parkview Regional Medical Center
  • Indiana University
  • Oschner Health System
  • Geisinger Medical Center
  • Baylor Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Arm 1 -modified wet suction

Arm 2- Slow Pull

Arm Description

Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction

Intervention: Procedure Core Liver Biopsy Technique: Slow Pull

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Complications
Tracking any complications that may be associated with each technique. Complications will be assessed and tracked following CTCAE V4.

Full Information

First Posted
July 17, 2017
Last Updated
March 15, 2022
Sponsor
Parkview Health
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1. Study Identification

Unique Protocol Identification Number
NCT03245580
Brief Title
Benign Liver Optimal Core Study (Tissue Acquisition Comparison in Benign Liver Disease)
Acronym
BLOCS
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 8, 2018 (Actual)
Primary Completion Date
September 15, 2020 (Actual)
Study Completion Date
September 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parkview Health

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Diseases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective, randomized, multicenter study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 -modified wet suction
Arm Type
Other
Arm Description
Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction
Arm Title
Arm 2- Slow Pull
Arm Type
Other
Arm Description
Intervention: Procedure Core Liver Biopsy Technique: Slow Pull
Intervention Type
Diagnostic Test
Intervention Name(s)
Core Liver Biopsy
Intervention Description
Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.
Primary Outcome Measure Information:
Title
Pathological Yield Fragmentation
Description
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.
Time Frame
At day 7 post biopsy
Title
Pathological Yield Length
Description
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.
Time Frame
At time of completion of pathology report
Title
Pathological Yield Quantity
Description
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.
Time Frame
At time of completion of pathology report
Secondary Outcome Measure Information:
Title
Complications
Description
Tracking any complications that may be associated with each technique. Complications will be assessed and tracked following CTCAE V4.
Time Frame
Complications occurring at time of consent, at procedure time and at day 7 post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil R Sharma, MD
Organizational Affiliation
parkview cancer institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Santa CLara Valley Medical Center
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
Facility Name
Parkview Regional Medical Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Oschner Health System
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Baylor Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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