Non-Alcoholic Steatohepatitis, Obesity
Conditions
Keywords
Non-Alcoholic Steatohepatitis (NASH), NASH with Fibrosis, Intragastric Balloon, Orbera, Orbera Intragastric Balloon
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.
Interventions
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.
PROCEDUREEndoscopic Ultrasound Guided Core Liver Biopsy
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Loss Achieved With Intragastric Balloon (IGB) | Baseline to 6 months post-procedure | 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
| Measure | Time frame | Description |
|---|---|---|
| Diagnosis of NASH and Early Fibrosis by Endoscopic Ultrasound (EUS) Guided Liver Core Biopsies | Baseline to 6 months post-procedure | Total number of subjects correctly diagnosed with NASH and Early Fibrosis by EUS guided core liver biopsies |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single All subjects will be receiving the Orbera Intragastric Balloon and will be undergoing Endoscopic Ultrasound guided core liver biopsy.
Orbera Intragastric Balloon: 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.
Endoscopic Ultrasound Guided Core Liver Biopsy | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Single | — |
|---|---|---|
| Age, Continuous | 54 years | — |
| Body Mass Index | 44 kg/m^2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 21 participants | — |
| Sex: Female, Male Female | 17 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 6 / 21 |
Outcome results
Primary
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).
Time frame: Baseline to 6 months post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single | Weight Loss Achieved With Intragastric Balloon (IGB) | 17 Participants |
Secondary
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
Time frame: Baseline to 6 months post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single | Diagnosis of NASH and Early Fibrosis by Endoscopic Ultrasound (EUS) Guided Liver Core Biopsies | 21 Participants |