STIRRED System for Fatty Liver

(STIRRED Trial)

Overseen By Danielle M McCarthy, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Liver disease, Multiple findings, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

4704 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Hepatic steatosis is a common radiographic "incidental finding" that is overlooked and underreported to patients. The investigators developed a clinical decision support system using machine learning and natural language processing that will prompt reporting to patients and provide ED clinicians risk stratified follow-up care recommendations. Data on both the implementation and effectiveness of our intervention resulting from this trial will inform future use with a goal of ultimately improving diagnostic safety and outcomes for patients with hepatic steatosis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What safety data exists for the STIRRED System for Fatty Liver treatment?

Some drugs for fatty liver disease, like pioglitazone, can cause bone thinning, fluid retention, and weight gain, while obeticholic acid may lead to itching. The long-term safety of vitamin E is uncertain, and elafibranor might temporarily increase creatinine levels, which is a kidney function marker. ^{1 2 3 4 5}

How does the STIRRED System for Fatty Liver treatment differ from other treatments for fatty liver disease?

The STIRRED System for Fatty Liver is unique because it likely involves a bioreactor-based approach that maintains liver cells in a three-dimensional culture, allowing for long-term study and drug testing in conditions that closely mimic the human liver environment. This method can help in understanding disease progression and testing new treatments more effectively than traditional methods. ^{6 7 8 9 10}

Who Is on the Research Team?

Amy V Kontrick, MD

Principal Investigator

Northwestern University

Danielle M McCarthy, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for individuals who have been identified with fatty liver conditions such as Non-alcoholic Fatty Liver Disease (NAFLD) during a radiographic exam. The study aims to include those where this finding might typically be overlooked.

Inclusion Criteria

Imaging finding of hepatic steatosis on ED imaging study

I was sent home after my emergency department visit.

My first visit to Northwestern Medicine ED showed fatty liver.

Exclusion Criteria

I am currently admitted to a hospital.

I am under 18 years old.

Multiple incidental findings on ED imaging study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the STIRRED CDSS intervention in the ED to identify hepatic steatosis and provide follow-up care recommendations

6 months

Ongoing ED visits

Follow-up

Participants are monitored for new steatotic liver disease-related diagnoses and completion of follow-up care

1 year

Evaluation

Evaluation of the effectiveness and fidelity of the STIRRED intervention

4 months

What Are the Treatments Tested in This Trial?

Interventions

• STIRRED

Trial Overview The STIRRED intervention, which uses machine learning and natural language processing, is being tested. It prompts doctors to report hepatic steatosis findings to patients and provides follow-up care recommendations based on risk levels.

How Is the Trial Designed?

Group I: STIRRED Experimental Treatment 1 Intervention

Patients with incidentally noted hepatic steatosis who are seen in Emergency Departments after STIRRED intervention has been activated within the local EHR may receive additional notification about steatosis, education or referrals for additional testing and follow-up as prompted by the STIRRED intervention which is directed at their discharging clinician.

Group II: Usual Care Active Control 1 Intervention

Includes any patient notification about steatosis, education and referrals as per the treating clinician's usual and customary practice.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

University of Texas, Southwestern Medical Center at Dallas

Collaborator

Trials

18

Recruited

21,200+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Published Research Related to This Trial

In a review of 15 randomized controlled trials involving both adults and children, metformin showed a significant effect on normalizing alanine transaminase levels compared to vitamin E, indicating its potential efficacy in treating nonalcoholic fatty liver disease (NAFLD).

While some treatments like pioglitazone showed reduced liver necrosis and inflammation, the overall limited data and methodological issues in the studies prevent definitive conclusions about the efficacy of various pharmacological and dietary interventions for NAFLD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological interventions for nonalcoholic fatty liver disease in adults and in children: a systematic review. Socha, P., Horvath, A., Vajro, P., et al.[2022]

Current treatments for nonalcoholic fatty liver disease (NAFLD) are still not very effective, but weight loss remains a key target for therapy despite being difficult to achieve.

Several investigational drugs show promise for treating NASH, but concerns about long-term safety exist, particularly with vitamin E and other medications like pioglitazone and obeticholic acid, which have notable side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment options for nonalcoholic steatohepatitis - a safety evaluation. Issa, D., Wattacheril, J., Sanyal, AJ.[2017]

In a meta-analysis of 41 randomized controlled trials involving 2,944 participants with non-alcoholic steatohepatitis (NASH), 68% of those on placebo experienced at least one adverse event (AE), highlighting the need for careful safety evaluations in this largely asymptomatic condition.

Serious adverse events were reported in 7.8% of placebo participants, with a notably higher incidence in phase 3 trials and those funded by pharmaceutical companies, indicating that the context of the study may influence safety outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo Adverse Events in Non-alcoholic Steatohepatitis Clinical Trials: A Pooled Analysis of 2,944 Participants. Tay, PWL., Ng, CH., Lin, SY., et al.[2023]

A systematic review of 37 studies involving 1107 patients indicates that fibrates, particularly fenofibrate and bezafibrate, are generally safe and well tolerated for treating primary biliary cholangitis (PBC), with low rates of adverse events.

While fibrates can improve biochemical parameters and reduce pruritus in cholestatic liver diseases, there is limited safety data for their use in primary sclerosing cholangitis (PSC), highlighting a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of fibrates in cholestatic liver diseases. Carrion, AF., Lindor, KD., Levy, C.[2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Pharmacological interventions for nonalcoholic fatty liver disease in adults and in children: a systematic review. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Treatment options for nonalcoholic steatohepatitis - a safety evaluation. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Placebo Adverse Events in Non-alcoholic Steatohepatitis Clinical Trials: A Pooled Analysis of 2,944 Participants. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Safety of fibrates in cholestatic liver diseases. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

From NAFLD to MAFLD: Aligning Translational In Vitro Research to Clinical Insights. [2022]

6. England pubmed.ncbi.nlm.nih.gov

A microfluidic patterned model of non-alcoholic fatty liver disease: applications to disease progression and zonation. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Bioengineered Multicellular Liver Microtissues for Modeling Advanced Hepatic Fibrosis Driven Through Non-Alcoholic Fatty Liver Disease. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Human Nonalcoholic Steatohepatitis on a Chip. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Establishing Liver Bioreactors for In Vitro Research. [2015]

10. England pubmed.ncbi.nlm.nih.gov

Validation of an adipose-liver human-on-a-chip model of NAFLD for preclinical therapeutic efficacy evaluation. [2022]