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EUS Guided Core Liver Biopsy and IGB Placement for the Diagnosis and Management of NASH and Obesity

Primary Purpose

Obesity, Non-Alcoholic Steatohepatitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Orbera Intragastric Balloon
Endoscopic Ultrasound Guided Core Liver Biopsy
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obesity focused on measuring Non-Alcoholic Steatohepatitis (NASH), NASH with Fibrosis, Intragastric Balloon, Orbera, Orbera Intragastric Balloon

Eligibility Criteria

22 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients diagnosed with Non-alcoholic Steatohepatitis with early evidence of fibrosis as seen on MRE-hepatogram
  • Referred clinically for an intragastric balloon placement for weight loss

Exclusion Criteria:

  • Women who are pregnant or plan to be pregnant or are breastfeeding
  • Previous history of gastric surgery
  • Current or recent (within 6 months) gastric or duodenal ulcers
  • Gastroparesis
  • Liver cirrhosis
  • Coagulopathy or active use of coagulation
  • Inability to provide a written informed consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Single

    Arm Description

    All subjects will be receiving the Orbera Intragastric Balloon and will be undergoing Endoscopic Ultrasound guided core liver biopsy.

    Outcomes

    Primary Outcome Measures

    Weight Loss Achieved With Intragastric Balloon (IGB)
    Total number of subjects with two points or greater improvement on objective Non-alcoholic Steatohepatitis (NASH) histopathological parameters. The NAS scale can range from 0 to 8 and is calculated by the sum of scores of steatosis (0-3), lobular inflammation (0-3) and hepatocyte ballooning (0-2).

    Secondary Outcome Measures

    Diagnosis of NASH and Early Fibrosis by Endoscopic Ultrasound (EUS) Guided Liver Core Biopsies
    Total number of subjects correctly diagnosed with NASH and Early Fibrosis by EUS guided core liver biopsies

    Full Information

    First Posted
    August 23, 2016
    Last Updated
    June 13, 2022
    Sponsor
    Mayo Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02880189
    Brief Title
    EUS Guided Core Liver Biopsy and IGB Placement for the Diagnosis and Management of NASH and Obesity
    Official Title
    Combined Endoscopic Ultrasound Guided Core Liver Biopsy and Intragastric Balloon Placement for the Diagnosis and Management of Nonalcoholic Steatohepatitis and Obesity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2016 (Actual)
    Primary Completion Date
    March 13, 2018 (Actual)
    Study Completion Date
    March 13, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mayo Clinic

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study is designed to investigate the impact of weight loss achieved with the IGB on NASH with early fibrosis in a select cohort of patients with obesity preselected to have a high pre-test probability of having NASH with early fibrosis based on magnetic resonance elastography (MRE)-Hepatogram. In addition, this study will explore potential non-invasive imaging criteria for NASH and early fibrosis using EUS-Elastography.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Non-Alcoholic Steatohepatitis
    Keywords
    Non-Alcoholic Steatohepatitis (NASH), NASH with Fibrosis, Intragastric Balloon, Orbera, Orbera Intragastric Balloon

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    21 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Single
    Arm Type
    Other
    Arm Description
    All subjects will be receiving the Orbera Intragastric Balloon and will be undergoing Endoscopic Ultrasound guided core liver biopsy.
    Intervention Type
    Device
    Intervention Name(s)
    Orbera Intragastric Balloon
    Intervention Description
    The Orbera Intragastric Balloon will be placed in the stomach endoscopically through a catheter under conscious sedation. The procedure takes about 20 minutes to complete. The balloon will stay in place for 6 months and then it will be removed endoscopically.
    Intervention Type
    Procedure
    Intervention Name(s)
    Endoscopic Ultrasound Guided Core Liver Biopsy
    Primary Outcome Measure Information:
    Title
    Weight Loss Achieved With Intragastric Balloon (IGB)
    Description
    Total number of subjects with two points or greater improvement on objective Non-alcoholic Steatohepatitis (NASH) histopathological parameters. The NAS scale can range from 0 to 8 and is calculated by the sum of scores of steatosis (0-3), lobular inflammation (0-3) and hepatocyte ballooning (0-2).
    Time Frame
    Baseline to 6 months post-procedure
    Secondary Outcome Measure Information:
    Title
    Diagnosis of NASH and Early Fibrosis by Endoscopic Ultrasound (EUS) Guided Liver Core Biopsies
    Description
    Total number of subjects correctly diagnosed with NASH and Early Fibrosis by EUS guided core liver biopsies
    Time Frame
    Baseline to 6 months post-procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    22 Years
    Maximum Age & Unit of Time
    69 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients diagnosed with Non-alcoholic Steatohepatitis with early evidence of fibrosis as seen on MRE-hepatogram Referred clinically for an intragastric balloon placement for weight loss Exclusion Criteria: Women who are pregnant or plan to be pregnant or are breastfeeding Previous history of gastric surgery Current or recent (within 6 months) gastric or duodenal ulcers Gastroparesis Liver cirrhosis Coagulopathy or active use of coagulation Inability to provide a written informed consent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Barham Abu Dayyeh, M.D.
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32360804
    Citation
    Bazerbachi F, Vargas EJ, Rizk M, Maselli DB, Mounajjed T, Venkatesh SK, Watt KD, Port JD, Basu R, Acosta A, Hanouneh I, Gara N, Shah M, Mundi M, Clark M, Grothe K, Storm AC, Levy MJ, Abu Dayyeh BK. Intragastric Balloon Placement Induces Significant Metabolic and Histologic Improvement in Patients With Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2021 Jan;19(1):146-154.e4. doi: 10.1016/j.cgh.2020.04.068. Epub 2020 Apr 30.
    Results Reference
    derived
    PubMed Identifier
    31437454
    Citation
    Bazerbachi F, Vargas EJ, Matar R, Storm AC, Mounajjed TM, Topazian MD, Levy MJ, Chandrasekhara V, Abu Dayyeh BK. EUS-guided core liver biopsy sampling using a 22-gauge fork-tip needle: a prospective blinded trial for histologic and lipidomic evaluation in nonalcoholic fatty liver disease. Gastrointest Endosc. 2019 Dec;90(6):926-932. doi: 10.1016/j.gie.2019.08.006. Epub 2019 Aug 19.
    Results Reference
    derived
    Links:
    URL
    https://www.mayo.edu/research/clinical-trials
    Description
    Mayo Clinic Clinical Trials

    Learn more about this trial

    EUS Guided Core Liver Biopsy and IGB Placement for the Diagnosis and Management of NASH and Obesity

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