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

NCT03245580 | Completed Results DMC FDA Device

• 1 other identifier: PRC17-0714
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 7

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).

Conditions

Liver Diseases

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Complications

  Complications occurring at time of consent, at procedure time and at day 7 post procedure

Study Arms (2)

Arm 1 -modified wet suction

OTHER

Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction

Diagnostic Test: Core Liver Biopsy

Arm 2- Slow Pull

OTHER

Intervention: Procedure Core Liver Biopsy Technique: Slow Pull

Diagnostic Test: Core Liver Biopsy

Interventions

Core Liver Biopsy DIAGNOSTIC_TEST

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

Arm 1 -modified wet suction; Arm 2- Slow Pull

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Parkview Health: lead

Study Sites (7)

University South Alabama

Mobile, Alabama, 36608, United States

Location

Santa CLara Valley Medical Center

San Jose, California, 95128, United States

Location

Parkview Regional Medical Center

Fort Wayne, Indiana, 46845, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Oschner Health System

New Orleans, Louisiana, 70121, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Baylor Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Results Point of Contact

• Title: Christina Zelt RN
• Organization: Parkview Mirro Research Center

christina.zelt@parkview.com

2602664153

Study Officials

• Neil R Sharma, MD

  parkview cancer institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President, Parkview Cancer Institute;Director Advanced Interventional Endoscopy & Endoscopic Oncology

Model Details: prospective, randomized, multicenter study

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: August 10, 2017
• Study Start: March 8, 2018
• Primary Completion: September 15, 2020
• Study Completion: September 15, 2020
• Last Updated: April 7, 2022
• Results First Posted: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)