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Status:

COMPLETED

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

Lead Sponsor:

Parkview Health

Conditions:

Liver Diseases

Eligibility:

All Genders

18+ years

Phase:

NA

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...

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 shal...

Eligibility Criteria

Inclusion

  • 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

    Key Trial Info

    Start Date :

    March 8 2018

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 15 2020

    Estimated Enrollment :

    153 Patients enrolled

    Trial Details

    Trial ID

    NCT03245580

    Start Date

    March 8 2018

    End Date

    September 15 2020

    Last Update

    April 7 2022

    Active Locations (7)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (7 locations)

    1

    University South Alabama

    Mobile, Alabama, United States, 36608

    2

    Santa CLara Valley Medical Center

    San Jose, California, United States, 95128

    3

    Parkview Regional Medical Center

    Fort Wayne, Indiana, United States, 46845

    4

    Indiana University

    Indianapolis, Indiana, United States, 46202