Transforming Non-Invasive Liver Disease Detection by MRE: The Hepatogram
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|ClinicalTrials.gov Identifier: NCT02565446|
Recruitment Status : Recruiting
First Posted : October 1, 2015
Last Update Posted : October 11, 2017
A variety of liver insults lead to pathological changes in liver architecture that culminate in cirrhosis. While invasive liver biopsy was required to detect cirrhosis, the development of magnetic resonance elastography (MRE) has revolutionized our ability to detect liver fibrosis through non-invasive means that involve measurement of liver stiffness. However, a number of pathological findings occur in liver in response to various insults that precede cirrhosis and are clinically important to identify such as steatosis associated with NASH, inflammation associated with viral hepatitis, and congestion associated with cardiac hepatopathy. Detection of such entities provides essential diagnostic, prognostic, and treatment information but yet is not available non-invasively. Recent murine studies from this group of investigators has identified that MRE technology can be adapted to non-invasively detect these conditions. Implementing this into the practice will transform it by obviating the need for invasive liver biopsies in patients suspected of having such forms of suspected liver disease. This will differentiate Mayo from other institutions where such technology is not available.
An additional aim of this study is to examine the impact of obstructive sleep apnea (OSA) on the pathogenesis of nonalcoholic fatty liver disease (NAFLD), both common comorbidities of obesity. Recent evidence indicates a potential link between OSA and severity of NASH and fibrosis, but the mechanisms of OSA- associated hypoxia on liver disease progression in NAFLD is unclear. This study offers the unique opportunity to analyze this association, as the study population will undergo routine evaluation for OSA, as part as the preoperative work-up prior to bariatric surgery.
|Condition or disease||Intervention/treatment||Phase|
|Obesity Fatty Liver||Device: Magnetic Resolution Elastography Procedure: Bariatric surgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transforming Non-Invasive Liver Disease Detection by MRE: The Hepatogram|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||December 2019|
To evaluate new MRE sequence that is capable of distinguishing liver fibrosis and inflammation. MRE has emerged as the potential alternative to invasive liver biopsy and possibly "the reference standard for non-invasive diagnosis of liver fibrosis". All 80 participants undergoing bariatric surgery will complete a non-invasive determination of liver inflammation and fibrosis by MRE. The proposed sample size for this experiment will be calculated based on sensitivity and specificity of MRE for differentiating various stages of fibrosis. We are looking for differentiation of simple steatosis from steatohepatitis and steatohepatitis with fibrosis.
Device: Magnetic Resolution Elastography
Correlation between histology and MRE with respect to liver fibrosis and inflammation.
Procedure: Bariatric surgery
Recruitment will be of patients who are scheduled to undergo bariatric surgery. During the time of surgery a liver biopsy will be taken clinically to identify liver disease. In addition, liver and fat tissue will be obtained for research purposes.
- The role of MRE as a non-invasive tool for estimation of inflammation and fibrosis in NAFLD. [ Time Frame: The outcome (correlation of liver histology with MR elastogram) will be assessed once, at the time of bariatric surgery. The enrollment will span over 14 months (10/2015 - 12/2016). No subsequent outcomes will be assessed after bariatric surgery. ]80 participants undergoing bariatric surgery will complete a non-invasive determination of liver inflammation and fibrosis by MRE. All subjects will undergo liver biopsy at the time of bariatric surgery. The liver tissue will be assessed for fat, inflammation, and fibrosis by pathology. We are looking for differentiation of simple steatosis from steatohepatitis and steatohepatitis with fibrosis by non-invasive measures such as MRE.
- Severity of liver fibrosis and adipose tissue dysfunction in obese patients with and without obstructive sleep apnea. [ Time Frame: Cross-sectional estimation of liver and adipose tissue histology between subjects with and without sleep apnea will be assessed once, at the time of bariatric surgery.The enrollment will span over 14 months (10/2015 - 12/2016). ]80 participants undergoing bariatric surgery will be assessed on parallel with the obesity epidemic, obstructive sleep apnea (OSA) affects millions of people in the US (approximately 50% of the obese subjects) and may represent an additional risk factor for liver fibrosis progression in patients with NAFLD. We will assess whether subjects with sleep apnea have worse fibrosis in the liver and fat tissue compared to subjects without sleep apnea.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02565446
|Contact: Suzanne M Greineremail@example.com|
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Vijay Shah, MD||Mayo Clinic|