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78 active trials for Liver Diseases

Social & Contextual Impact on Children Undergoing Liver Transplantation

The social determinants of health have a large impact on health. For example, neighborhood socioeconomic deprivation is associated with increased risk of medication non-adherence, graft failure, and death in children after liver transplant. In order to address these socioeconomic inequities in outcomes, a more granular understanding of how the social determinants of health impact outcomes is needed. In this observational prospective cohort, caregivers of children undergoing liver transplantation will complete surveys and undergo in-depth, qualitative interviews. The survey will assess comprehensively for the social determinants of health (e.g. material economic hardship, health literacy, social connectedness, primary care quality, etc). The qualitative interviews will identify barriers and facilitators that socioeconomically deprived children/families have to obtaining the ideal outcome and identify health system opportunities to integrate social needs and medical care. Data will be linked to an existing prospective cohort study (The Society for Pediatric Liver Transplant registry) to assess the impact of social risk on outcomes after transplant. Healthcare providers who take care of children undergoing liver transplant will also be included in the qualitative interviews. The goal of including this group in the study is to determine the health systems barriers and facilitators to social needs screening and intervention.

Start: September 2020

A Phase 1, Multicenter, Open-Label Study to Evaluate the Effect of Mild or Moderate Hepatic Impairment on the Multiple-Dose Pharmacokinetics of Ozanimod

This is a Phase 1, multicenter, nonrandomized, open-label, parallel-group study in participants with mild or moderate hepatic impairment, and in participants with normal hepatic function. Degrees of hepatic impairment will be determined during screening by the participant's score according to Pugh's Modification of Child's Classification of Severity of Liver Disease. Participants will be enrolled in Groups 1 through 3 as follows: Group 1 (mild hepatic impairment): A total of approximately 8 participants with a Child-Pugh score of 5 to 6. Group 2 (moderate hepatic impairment): A total of approximately 8 participants with a Child-Pugh score of 7 to 9. Group 3 (normal hepatic function): Approximately 8 to 16 participants will be matched to Participants in Groups 1 and 2. Normal hepatic function participants are allowed to match multiple hepatic impairment participants. Participants will be matched by sex, age (± 10 years), weight (± 20%), and smoking status.

Start: December 2020

Sexual Dysfunction in Patients With Chronic Liver Disease

This project will determine the incidence of sexual dysfunction in patients with chronic liver disease, through questionnaires. The questionnaires have been designed to assess several facets of sexual health, e.g. libido, physical symptoms, depression, etc. 150 patients in our liver outpatient department, and 150 healthy volunteers will be asked to fill in the questionnaire in paper form. The results of this project will be used to produce patient resources, advice sheets and educational materials for patients with chronic liver disease. There is also scope to consider possible interventions in the future to improve sexual dysfunction in patients with chronic liver disease.

Start: June 2021

Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements

The objective of the study is to collect and report technical success of direct endoscopic ultrasound guided hepatic and portal vein pressure measurement obtained with EchoTip® Insight™ in patients with cirrhosis who are referred for an EGD and/or EUS.

Start: April 2021

Intraoperative Hemodynamic Management and Postoperative Outcomes in Liver Transplantation

The overarching objective of the research program entitled ELIPTO (Enhancing Liver Insufficiency and Postoperative Transplantation Outcomes) (www.elipto.ca) is to improve the perioperative care of liver transplant recipients. One of this program's purposes is to better define the effects of intraoperative hemodynamic management on postoperative outcomes in adult liver transplant recipients. In this study, the incidence of postoperative complications within this population will be defined in Canada and the association between intraoperative hemodynamics and postoperative outcomes will be measured. Liver transplantation improves the survival of patients with end-stage liver disease (ESLD). It is the second most transplanted organ with a continuously increasing annual number of transplantations, an observation partly explained by an endemic ESLD etiology in the United States, the obesity-related non-alcoholic steatohepatitis (NASH) cirrhosis. In recent decades, although sicker patients are prioritized, survival has improved possibly through an overall improvement in the quality of care. However, postoperative complications have concomitantly increased. On average, liver transplant recipients suffer from more than three postoperative complications, mainly infectious, pulmonary, renal or graft-related, two thirds of them being severe. In a low-risk patients cohort, close to 60% of all patients suffered from at least one severe complication up to 6 months after surgery. Such complications increase mortality, readmissions and cost of care. Organs available for transplantation are a scarce resource; up to 10% of grafts are no longer functional after one year. Interventions that improve patients' postoperative and graft outcomes are needed and few perioperative ones are supported by high-quality evidence.

Start: June 2021

Repeatability and Reproducibility of Multiparametric MRI

This study aims to prospectively assess the repeatability and reproducibility of iron-corrected T1 (cT1), T2*, and hepatic proton density fat fraction (PDFF) quantification with multiparametric MRI using the LiverMultiScan™ (LMS, Perspectum Diagnostics, Oxford, UK) protocol across different field strengths, scanner manufacturers and models.

Start: June 2017

Normothermic Liver Preservation Trial

This trial is to assess the safety and efficacy of normothermic machine perfusion (NMP) as an organ preservation method prior to transplantation using the OrganOx metra™ device.

Start: February 2017

Intraoperative Phlebotomies and Bleeding in Liver Transplantation

Liver transplantation are surgeries associated with important bleeding and often require perioperative red blood cell (RBC) transfusions. Overall, between 20 and 85 % of liver transplant recipients receive at least one RBC transfusion during their surgery. Such transfusions are consistently associated with higher morbidity and mortality, although this causal association is still under debate in many surgical populations. Despite the lack of clear causative association between perioperative transfusions and worse outcomes, minimizing bleeding and transfusions is believed to improve postoperative outcomes. Many perioperative variables are associated with higher blood loss and need for perioperative transfusions: liver disease severity, preoperative anemia and coagulopathy, higher cardiac filling pressures and higher fluid administration, among others. However, few perioperative interventions have been shown to reduce bleeding and transfusion requirements in this population. Among them, the use of intraoperative phlebotomies to reduce portal and hepatic venous pressure during the dissection phase is a promising one, also described in liver resection surgery. To further investigate the effects of intraoperative phlebotomies on intraoperative bleeding, perioperative transfusions and mortality, the Principal Investigator will conduct a retrospective cohort study with a propensity score based causal analysis.

Start: March 2021

Pharmacokinetics of Paclitaxel in Correlation With Adverse Events in Cancer Patients With and Without Liver Impairment

The study aims to assess the pharmacokinetics of paclitaxel and its two major metabolites in patients with normal and impaired liver functions.

Start: August 2020

Primary Sclerosing Cholangitis in Children

Primary sclerosing cholangitis (PSC) is a rare liver disease that damages the liver's bile ducts. Bile ducts are tiny tubes that carry bile from the liver to the small intestine. Bile is a liquid produced by the liver that helps us absorb and use the nutrients in the food we eat. In people with PSC, the bile backs up into the liver and will damage it, causing scarring of the liver. The purposes of this study are to: Collect medical and other data to learn more about PSC, how it progresses, and identify factors that may cause the disease to progress more quickly. Ask questions about how PSC symptoms affect your child's life to learn more about its impact on your child's daily functioning Children with PSC who are seen at one of the participating clinical sites in the Childhood Liver Disease Research Network (ChiLDReN) will be asked to contribute information, DNA, and other specimens. The information and specimens will be available to investigators to carry out approved research aimed at learning more about the possible causes and long-term effects of PSC.

Start: July 2021

Hemodynamic Alterations in Liver Cirrhosis Validated by Non-invasive MR Compared to Invasive Assessment

Liver cirrhosis is a chronic disease characterized by a progressive accumulation of fibrosis, loss of liver function and portal hypertension leading to several hemodynamic changes.The exact pathophysiological mechanisms causing the hyperdynamic alterations in cirrhosis are not fully elucidated. Aim: The aim of the study is to assess hemodynamic alterations in liver cirrhosis by non-invasive MRI and echocardiography compared to portal hypertension measured with liver vein catheterization (HVPG, hepatic vein pressure gradient). Furthermore, the aim is to explore hemodynamic differences between cirrhotic patients and healthy subjects. Study design and cohort: The study has a cross-sectional design and a cohort with 99 patients with liver cirrhosis - with and without complications and 27 healthy volunteers. The patients are recruited at the Gastrounit Hvidovre University Hospital. The day before the first visit patients are hospitalized and fasting overnight. At first visit liver vein catheterization (LVC) and echocardiography are performed. Second visit must be performed within 4 weeks after first visit. At the second visit patients are fasting minimum 6 hours before having MR-flow scanning, cardiac-MR and MR-Elastography (MR-E). The healthy volunteers are only offered MR-flow scanning, cardiac MR and MR-E as well as urine- and blood tests Follow-up for liver-related clinical outcome and mortality in medical records

Start: April 2017

Breath Analysis Based Disease Biomarkers of COVID-19 and Other Diseases

The purpose of the study is to develop a clinical test based on breath analysis that can be used for disease diagnosis or prognosis.

Start: September 2019

Mortality, Morbidity and Risk Factors of Liver Retransplantation

This study aims to compare the short and long term outcomes of living donor and deceased donor liver retransplantation. Bearing that in mind, the investigators will retrospectively analyze the files of patients whom underwent a liver retransplantation in Memorial Bahcelievler Hospital Organ Transplantation Center.

Start: March 2021

Cohort/Ethics Study of Patients With Severe Alcoholic Hepatitis Undergoing Early Liver Transplantation

The purpose of this study is to develop a clinical understanding of early liver transplantation (ELT) for patients with severe alcoholic hepatitis (SAH) and identify the public's opinion regarding this practice.

Start: April 2020

Liver Transplantation for Unresectable GIST Liver Metastases

Start: September 2021

An Observational Study of Patients Undergoing Therapy for Chronic Hepatitis B (HBV) Infection

The TARGET-HBV study engages an observational research design to conduct a comprehensive review of therapeutic outcomes for patients with chronic hepatitis B (HBV) who are currently taking tenofovir alafenamide (TAF) relative to those patients following other treatment regimens. The study will address important clinical questions regarding the management of HBV with TAF and other oral therapies by collecting and analyzing data from patients at academic and community medical centers. TARGET-HBV creates a robust database of real-world data regarding the natural history, management, and health outcomes related to TAF.

Start: October 2018

Non-invasive Ultrasound Diagnosis of Chronic Liver Diseases in Hepatology Consultation

Early screening and monitoring of chronic liver diseases in hepatology practice has become crucial. To achieve this goal, hepatology clinics need simple and available tools at the point-of-care to perform disease severity assessment. The objective of this study is to assess the performance of a new non-invasive ultrasound-based system for the assessment of liver fibrosis and steatosis severity, via ultrasound biomarkers such as tissue stiffness (correlated to fibrosis severity) and ultrasound tissue attenuation (correlated to steatosis extent).

Start: May 2021

YMCA Diabetes Prevention Program for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD)

This study is for men and women have been diagnosed with non-alcoholic fatty liver disease (NAFLD) and will consequently participate in the YMCA's Diabetes Prevention Program.

Start: January 2018

Investigation of Mortality, Morbidity and Risk Factors After Pediatric Liver Transplantation

The Department of Organ Transplantation in Memorial Hospitals has started Pediatric Liver Transplantation Program in 2016. As of the end of 2020, we have performed 169 pediatric liver transplantation. The aim of this study is to investigate the overall mortality, morbidity and risk factors for adverse outcomes in pediatric liver transplantation. The patients' records will be retrospectively scanned and the data will be gathered.

Start: February 2021

Liver Disease, Myocardial Fibrosis and Collaterals in the Adult Fontan Patient a Metabolomics and Proteomics Approach

Out objective is to identify the mechanisms that promote hepatic and myocardial fibrosis, and collateral vessel formation in patients with complex congenital heart disease and Fontan circulation.

Start: July 2021