N/A
N=21
EUS Guided Core Liver Biopsy and IGB Placement for the Diagnosis and Management of NASH and Obesity
Obesity · Non-Alcoholic Steatohepatitis
Bottom Line
View on ClinicalTrials.gov: NCT02880189 ↗Enrolled (actual)
21
Serious AEs
28.6%
Results posted
Apr 2019
Primary outcome: Primary: Weight Loss Achieved With Intragastric Balloon (IGB) — 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Orbera Intragastric Balloon (Device); Endoscopic Ultrasound Guided Core Liver Biopsy (Procedure)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight Loss Achieved With Intragastric Balloon (IGB) |
17 | — |
| SECONDARY Diagnosis of NASH and Early Fibrosis by Endoscopic Ultrasound (EUS) Guided Liver Core Biopsies |
21 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02880189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.