300,000+ clinical trials. Find the right one.

78 active trials for Liver Diseases

Pain Scores and Complications do Not Differ at Three Recovery Position After Liver Biopsy

Liver biopsy is still used as the gold standard in the diagnosis of many liver diseases. During the observation after liver biopsy, patients are hospitalized on their right side, which is the biopsy side, with the thought that adverse events (complications) such as bleeding or bile leakage will be less. Patients who do not develop complications after 4-6 hours of observation are discharged home. Some of the patients state that the right side-lying position for 4-6 hours is uncomfortable than the biopsy itself, and they prefer to lie on their back. In our study, researchers aim to investigate the rate of complications after biopsy, what recovery position found more acceptable by the patients.

Start: January 2018

MRI to Assess the Effect of Terlipressin in Patients With Acute Hepatorenal Syndrome (HRS-AKI)

HRS is divided into two types. A chronic kidney failure (HRS-2), which is predominantly related to end-stage disease and a more acute kidney failure (HRS-AKI). HRS-AKI is potentially reversible and develops subsequent to aggravation of a systemic circulatory vasodilatation, that triggers renal vasoconstriction and deteriorates renal perfusion and function. The albumin and terlipressin response is evaluated clinically, routinely for a week and reduces mortality with 23% compared to no treatment. Only 40-50% of the patients with HRS-AKI respond to the treatment with terlipressin. The treatment of hepatorenal syndrome type 1 (HRS-AKI) is aimed at improving blood flow to the kidneys. Flow changes associated to development of HRS have only sparsely been studied and not previously by MR technique and no previous studies have evaluated changes in flow induced by terlipressin. It has been hypothesized that development of HRS is associated to a deterioration in heart function with development of cardiomyopathy, which together with renal vasoconstriction leads to renal failure. Simultaneous MR-assessments of cardiac function and flows (especially the renal flow) in HRS-AKI have not previously been performed. The aim of the project is to develop new, fast and non-invasive methods to evaluate hemodynamic changes and individual pharmacological terlipressin response in patients with acute hepatorenal syndrome (type HRS-AKI) We expect a higher increase in renal blood flow in terlipressin-responders compared to terlipressin-non-responders and non-responders will generally have a lower basic renal flow and a decreased cardiac output. Study design and patients The study design is experimental and includes 30 cirrhotic patients with HRS-AKI. Patients with HRS-AKI are MR scanned before and 17 minutes after their first dose of terlipressin. ECHO is performed before first dose of Terlipressin and is repeated after one of the first doses of terlipressin. Clinically efficacy is defined in accordance to international guidelines at day-7 and 90 days mortality is registered. The screening period and treatments follow international and national guidelines for acute renal failure in patients with cirrhosis.

Start: January 2018

30-to-90 Day Challenge: Effects of Alcohol Cessation on Health Outcomes

The objective for this project is to determine whether how certain behavioral and health functions change in persons with heavy drinking when they stop (or reduce) drinking for 30 days, and whether changes continue for up to 90 days. The study will also identify barriers and facilitators related to drinking reduction. The project will focus on clinical comorbidities including HIV disease control, cognitive and brain function, liver abnormalities, and chronic inflammation. The study teams propose to enroll 140 HIV+ and 40 HIV- adults with heavy drinking, and then use Contingency Management (CM) with financial incentives to encourage participants to maximally reduce alcohol consumption for 30 days. Participants will be required to wear an ankle biosensor (SCRAM monitor) at all times, which is used to monitor participants' drinking behavior. At 30 days, participants will complete a full day of follow-up, including cognitive testing, neuroimaging, blood testing, liver Fibroscan, and questionnaires. Many participants will also provide a stool sample for gut microbiome assessment at each time point. At 30 days, participants will participate in a motivational interview to discuss perceived benefits and obstacles to drinking reduction, and most participants will continue CM to 90 days (but can opt out at this point). Participants will complete another full-day assessment at 90 days, at which point persons may choose to drink or not on their own (no more CM). A final assessment will be conducted at 12 months. This A-B-A design will enable us to clearly identify whether alcohol effects on cognition and brain function are reversible in the context of HIV, and analyze specific cerebral and systemic pathophysiological factors contributing to these effects. The inclusion of HIV- adults will enable subgroup comparisons of alcohol reduction effects in the context of HIV vs. no-HIV. These HIV-negative participants will be recruited from the same settings as our HIV+ participants, and will include a similar proportion by age, race, and gender as the HIV+ participants. The study team will use information from the MI data and our other assessments to elucidate factors that predict both short term (during CM) and long-term (1-year) alcohol reductions, and study how changes in alcohol consumption affect important HIV clinical outcomes that will be monitored over time.

Start: December 2017

Mean Systemic Filling Pressure Trends in Liver Transplant Recipients

Patients with end stage liver disease undergoing liver transplantation have varying degrees of intraoperative haemodynamic unstability during various phases of transplantation. It is difficult to determine the cause for hemodynamic instability in these patients and to predict the best treatments. Currently, cardiovascular resuscitation options are triggered by arterial pressure and cardiac output (CO) measures, focusing on the oxygen delivery side of the circulation. The primary determinants of cardiac output reside on the venous side. Veins are 30-50 times more compliant than arteries and contain approximately 75% of the total blood volume. Mean systemic filling pressure provides vital information on this venous side of the circulation. Mean systemic filling pressure , which is defined as the pressure equal to the pressure which would be measured if the heart should suddenly stop pumping and all (arterial and venous) the pressures in the entire circulatory system should be brought to equilibrium instantaneously, is a good, complete and reliable reflection of the total intravascular fluid compartment. We would study the Mean systemic filling pressure in liver transplant recipients and record hemodynamic, respiratory, cardiac and renal function prospectively. Follow up data for 7 days for respiratory, cardiac and renal complications will be collected, along with hospital stay, ICU stay and mortality. The association between Mean systemic filling pressure and these outcomes will be analyzed.

Start: July 2020

Organ Dysfunction Associated With Intra Abdominal Pressures in Liver Transplantation

Patients with end stage liver disease have varying degrees of intra-abdominal hypertension (IAH) due to the presence of ascites. The perioperative events may either relieve or aggravate the intra-abdominal pressures. Intra-abdominal hypertension has damaging effect on various organ systems. There is an increase in intracranial pressures and a decrease in cerebral perfusion pressures associated with IAH . In the heart, there is an increase of right atrial pressures, increase in systemic vascular resistance and decrease in cardiac output . Pulmonary complications include increase in the peak, mean and plateau airway pressures, with decreased compliance . Renal dysfunction is an early effect of raised intra-abdominal pressure, resulting from decreased renal blood flow, shunting of blood to the medulla, mechanical compression of the kidneys and increased pressures in the renal veins . We would study the intra-abdominal pressures in liver transplant recipients and record hemodynamic, respiratory, cardiac and renal function prospectively. Follow up data for 6 days for neurological, respiratory, cardiac and renal complications will be collected, along with hospital stay, ICU stay and mortality. The association between intra-abdominal pressures and these outcomes will be analysed.

Start: July 2020

The BRAINFOOD Trial to Prevent Recurrent Hepatic Encephalopathy.

This study is being completed for patients with cirrhosis, including patients with a prior history of hepatic encephalopathy (HE) to evaluate the feasibility and benefits of medically-tailored meals as an intervention. Patients will be enrolled from the University of Michigan and will complete the baseline assessments in-person or remotely. In addition participants will complete study related materials before, during and after treatment with medically-tailored meals (MTM). After completing the study meals, participants will return for follow-up or have this visit completed remotely as well as have an observational period for 12 more weeks.

Start: January 2021

Physiologic and Functional Adaptations of Insulin Sensitive Tissues

The long-term goal is to understand the mechanisms of intestinal nutrient sensing and signal relays to insulin sensitive tissues (adipose, skeletal muscle, liver) in humans. The investigators hypothesize that human tissue biopsies (from obese surgery and non-surgery subjects as well as lean controls) can be used to understand the molecular mechanisms underlying intestinal nutrient sensing and signal relay in humans. The investigator will obtain tissue specimens from patients during scheduled upper endoscopies, colonoscopies and scheduled metabolic and bariatric surgeries or liver transplantation. A blood sample (4mL) will be obtained concurrent with these procedures. From metabolic and bariatric surgery subjects blood and tissues (liver, adipose, small intestine, omentum, skeletal muscle) can be collected at the time of surgery. From liver transplantation patients, excised liver tissue will be collected. Stool can be obtained preoperatively and at various time points after surgery. Some bariatric surgery subjects will participate in a mixed-meal tolerance test at their pre-operative visit and several post-operative visits to compare the whole-body metabolic alterations following bariatric procedures.

Start: February 2018

Ketogenic Diet in Non-alcoholic Fatty Liver Disease

The purpose of this randomized trial is to examine the effects of a ketogenic diet on non-alcoholic fatty liver disease (NAFLD). Twenty-four participants with NAFLD will be randomized to receive a ketogenic meal plan or control (standard weight loss meal plan). Participants will be followed up to 28 days after initiation of the diet intervention.

Start: March 2019

S.P.PRO LIVER POWDER is Used to Improve Liver and Metabolic Indexes in People With Non-alcoholic Fatty Liver Disease

With the Westernization of the diet and insufficient exercise, Taiwan's population of obesity, diabetes, and hyperlipidemia has increased in recent years, and the prevalence of the non-alcoholic fatty liver disease has gradually increased. Although weight loss, dietary adjustments, and certain drug treatments can delay the deterioration of the disease; however, weight loss and dietary adjustment are not easy.

Start: January 2021

To Describe the Clinical, Endoscopic and Endoscopic Ultrasound Features of Non-bleeding and Bleeding Rectal Varices, Among Patients With Portal Hypertension

Rectal varices (RVs) are an important cause of lower gastrointestinal bleed (LGIB) in portal hypertension (PHT) and have been reported to occur in 44% to 89% of cases of cirrhosis. RVs are dilated sub-mucosal porto-systemic communications which extend from mid rectum to the ano-rectal junction and are considered distinct from internal hemorrhoids, which are submucosal arterio-venous communications of the anorectal vascular plexus. The suspicion of RVs as the cause of bleeding can be made with a high index of suspicion when lower GI bleed is seen in absence of hemorrhoids, and colonoscopy shows blood in rectum. Bleeding usually happens from endoscopically evident rectal varices (EERV) but sometimes bleed can occur from varices, which are endoscopically in evident (EIERV). Endoscopic ultrasound (EUS) has been shown to be more sensitive in diagnosis of EIERV. Endoscopic and EUS correlation of RVs has shown that RVs, classified as tortuous, nodular, and tumorous on endoscopic examination, have corresponding appearances on rectal EUS as single, multiple, and innumerable submucosal veins, respectively. The hemodynamic evaluation (HDE) of RVs by EUS is routinely done at some centers to assess parameters like the site, size, velocity, or direction of flow.

Start: January 2021

Monocytic Expression of HLA-DR After Liver Transplantation

A defect of the immune response has been described in patients with severe liver disease. This immune-paresis is partly driven by a compensatory anti-inflammatory response following a systemic inflammatory response syndrome and affects the innate immune response. The innate immune defect has been described in patients with advanced cirrhosis and more significantly in patients with acute liver failure or acute on chronic liver failure (ACLF). The monocytes/macrophages pro-inflammatory response and finally the antimicrobial response are thus strongly impaired, leading to higher sepsis risk. The monocytes/macrophages phenotype associated with these functional alterations has been widely described, with a weaker expression of Human Leukocyte Antigen - DR isotype (HLA-DR) on the monocytes surface, correlated with poor outcomes. The low monocytic expression of HLA-DR, its functional and clinical impact has been widely described in the context of septic shock with similar pathophysiological mechanisms. Liver transplantation (LT) is often the only therapeutic option for patients with advanced liver failure. Post-transplant survival of the most severe patients is similar to the survival in the whole population of LT patients, but the complication rate remains higher, with a major risk of infection. Currently used immunosuppression protocols do not take into account the quality of pre-transplant immune response. Some treatments, such as corticosteroids, which are widely used for the induction of post-transplant immunosuppression, may affect the innate immune response. However, it has been shown that low expression of post-transplant monocyte HLA-DR was associated with a greater risk of septic complication. The general objective of this study is to focus on the evolution of a robust marker of immune dysfunction, HLA-DR monocyte expression, before and following LT, and to analyse its post LT expression depending on the level of pre-transplant expression as well as its association with post-transplant complications. This study will bring new insights for the design of a prospective study on the relevance of adapting post-transplant immunosuppression protocols to HLA-DR expression on monocytes surface, which is a robust marker of the innate immune response. Evaluation of innate immune dysfunction pre-LT by quantification of monocytic HLA-DR expression and monitoring of its post-LT kinetics may be relevant for assessing post-transplant immune status and adapting immunosuppressive therapy. A descriptive, observational study associating clinical and biological data is needed to confirm the relevance of HLA-DR expression quantification on the surface of monocytes in a population of selected patients, before and after LT. These data will allow setting up a prospective interventional study reporting the possible benefit of post-transplant immunosuppressive treatment modulation, according to the HLA-DR monocyte dosage and its kinetics evolution. The main objective of this study is to describe the association between evolution of monocytic HLA-DR expression on monocytes/macrophages surface during the first month after LT and the occurrence of one of the 2 following clinical events reflecting a post LT immune dysfunction (acute cell rejection and sepsis).

Start: February 2020

Prehabilitation Intervention to Maximize Early Recovery (PRIMER) in Liver Transplantation

This is a single center, 2-arm, patient-randomized study evaluating the feasibility and potential efficacy of the PRIMER intervention in improving physical function and reducing frailty in adult Liver Transplant candidates. The intervention will consist of a patient-tailored prehabilitation program designed to reduce frailty, improve physical function and nutritional status, and optimize pre- and post-transplant outcomes.

Start: February 2018

Prevention of Post-TIPS Hepatic Encephalopathy by Administration of Rifaximin and Lactulose

Rationale: Hepatic encephalopathy (HE) is a major and common complication in patients with liver cirrhosis. HE can be classified in the extensive range of neurocognitive deterioration as minimal HE (MHE), covert HE (grade I), or overt HE (OHE, grade II-IV). Liver cirrhosis is the most common cause of portal hypertension (PH). Patients who develop complications of PH, like variceal bleeding or refractory ascites, can benefit from a Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement. Unfortunately, post-TIPS HE is a common and often severe complication. Incidence of new onset or worsening of HE after TIPS is approximately 20-45%. Currently there is no strategy to prevent post-TIPS HE.

Start: January 2020

Diagnostic and Evaluation of Hepato-pancreatico-biliary Disease With MRI

This is a retrospective review of images from patient data. There is no recruitment necessary for this study. Research Question: Can advanced multiparametric MRI techniques improve the detection and characterization of focal and diffuse liver disease, accurately assess treatment response and predict patient outcomes based on longitudinal monitoring? Hypotheses: Advanced multiparametric MRI techniques improve the detection, characterization and response assessment of focal and diffuse liver disease and can predict serious liver related outcomes.

Start: June 2020

Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease

The main objective of this study is the comparison of the profile of the pro-inflammatory cytokines at the patients suffering from an alcoholic hepatitis to that of two groups witnesses: patients suffering from an alcoholic cirrhosis and unhurt patients of chronic liver disease

Start: September 2015

TIPS Combined With Microwave Ablation in HCC Patients With Refractory Ascites

Transjugular intrahepatic portosystemic shunt (TIPS) could effectively decrease portal hypertension-related complications. This study intends to evaluate the efficacy and safety of TIPS combined with subsequent microwave ablation in HCC patients with refractory ascites.

Start: February 2021

RESTORE Declined Livers Study

This is a prospective, non-randomized, clinical trial of discarded liver transplants that have received normothermic machine perfusion (NMP), compared with standard cold preservation liver transplants. The discarded livers rejected by all other centers and meeting pre-NMP eligibility criteria will receive NMP using the OrganOx® metra device. The NMP-treated liver that meets the viability criteria will be transplanted to patients who are eligible and consented to the study. Liver transplant outcomes will be ascertained during 12 months post-transplantation. The results of the trial will be compared with those of contemporary comparison groups of patients who received the standard criteria donor liver transplantation.

Start: December 2020

Heal-Me Personalized Online Nutrition and Exercise Routines

The purpose of this study is to compare 12-weeks of virtual multidisciplinary programming provided at three levels of support intensity to determine impacts on clinical outcomes, acceptability, and cost amongst outpatients with cancer, liver disease, or lung disease. Participants will be randomized to one of three groups: (i) standard care, (ii) a personnel-light app-based intervention, (iii) a personnel-intensive app-based intervention. Participants randomized to standard care will receive exercise and nutrition resources as well as a Garmin watch. Participants in the experimental groups will receive standard care, plus a 12-week multidisciplinary app-based personalized program involving 12 weeks of exercise programming and 10-weeks of nutrition programming. Participants in study group 3 will receive additional one-on-one care. The Research Ethics Board at the University of Alberta has approved this study. The protocol will measure patient-related outcome measures including physical function, quality of life, social isolation, and anxiety, as well as measures of acceptability and cost. 216 participants will take part in this study (n=72 per arm). Analyses: fitness testing and patient-reported outcomes will be administered before and after the intervention. Fitness and patient-reported outcomes will be compared using linear mixed models with random effects. App acceptability will be compared between groups using Chi-Square.

Start: November 2020

Biliary Anastomosis Using Surgical Loupe Versus Microscope in Living Donor Liver Transplantation

Comparison of biliary complications in right lobe living donor liver transplantation patients undergoing biliary reconstructions using microscope versus surgical loupes .

Start: December 2020

Give a MANNA a Fish, Teach a MANNA to Fish

This study is a randomized pilot seeking to address low patient adherence to a low sodium diet as a strategy to improve outcomes of patients with cirrhosis of the liver. In coordination with the Metropolitan Area Neighborhood Nutrition Alliance (MANNA) of Philadelphia, patients in the intervention cohort will receive low sodium MANNA meals to encourage improved dietary compliance. Outcomes of these interventional patients will be compared to those receiving standard of care--namely, educational intervention by physicians supplemented by occasional counseling from dieticians during clinic visits encouraging a low sodium diet. Dietary compliance will be evaluated by urine sodium and salt affinity tests and used as a positive marker for improved outcomes. The target population of this study is patients diagnosed with cirrhosis of the liver, aged 18-85 years living within the MANNA-serviced area.

Start: March 2021