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Liver Diseases clinical trials

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NCT ID: NCT02758977 Not yet recruiting - Surgery Clinical Trials

Associating Liver Partition With Portal Vein Ligation for Staged Hepatectomy (ALPPS) vs. Two-Stage Hepatectomy (TSH) for Marginally Resectable Colorectal Liver Metastases (CRLM)

ALPPSforCRLM
Start date: May 2016
Phase: N/A
Study type: Interventional

Surgical resection has offered the best option for prolonged survival in patients with colorectal liver metastases. Limiting factor for major liver resections is the size of the future liver remnant (FLR). In case of normal liver function, 30% of the total liver volume is considered to be sufficient to maintain adequate liver function after resection. In an attempt to further increase "resectability" criteria for patients with too small FLR surgical and interventional maneuvers such as portal vein embolization and portal vein ligation in two-stage hepatectomies have been implemented, but they need an interval of 4-8 weeks to achieve sufficient hypertrophy. In order to obtain adequate but rapid parenchymal hypertrophy a new surgical two-step technique, ALPPS, was introduced for oncological patients requiring extended hepatic resection with limited functional reserve. Both procedures can be performed with acceptable morbidity and mortality. The investigators conclude that it is time to perform a randomized study comparing the two surgical approaches in regard to oncological outcome.

NCT ID: NCT02758834 Completed - Liver Diseases Clinical Trials

Half-life of Plasma Phytosterols in Preterm Infants on Parenteral Nutrition

Start date: January 2014
Phase: N/A
Study type: Observational

The purpose of this study is to determine plasma phytosterols half-lives in preterm infants who received intravenous soy oil-based lipid emulsions.

NCT ID: NCT02717949 Terminated - Liver Disease Clinical Trials

Oral Hepatitis C Treatment for Indolent Lymphoma (OPTImaL) Study

Optimal
Start date: February 25, 2016
Phase: Phase 4
Study type: Interventional

There still remains the question if hepatitis C eradication with all oral therapy will lead to a regression or cure of the low grade lymphoma. Thus, the hypothesis of this study is that oral HCV therapy will lead to a high rate of hepatitis C eradication which will correlate with a reduction of the size and extent of low-grade lymphoma. The hypothesis of this study is that subjects with hepatitis C,regardless of genotype, who have low grade lymphoma, when treated for hepatitis C without pegylated interferon will have a regression of low grade non-Hodgkin's lymphoma. In this pilot study we will evaluate the effect of Sofosbuvir/ledipasvir or sofosbuvir/ribavirin based antiviral therapy on the course of a subset of HCV-related low grade B cell non-Hodgkin's lymphoma Primary Objective This study will assess the safety, as measured by adverse events, in subjects receiving hepatitis C treatment. Secondary Objective The secondary objective of this study is to assess the rate of overall response of B cell non-Hodgkin's lymphoma defined as either as partial response or complete response according to revised international working group criteria for non-Hodgkin lymphoma. Primary Endpoint Safety and tolerability of sofosbuvir/ledipasvir or sofosbuvir/ribavirin in subjects with B-cell non-Hodgkin's lymphoma will be assessed by number of adverse events and serious adverse events. In addition, the study will assess the number of subjects who had to stop treatment due to adverse events or serious adverse events. The study will also examine the number of subjects in which treatment for lymphoma had to be given due to clinical progression. Secondary Endpoints The secondary endpoint(s) of this study is to (1) Assess the rate of overall response of B-cell Non-Hodgkin's lymphoma defined as either as partial response or complete response according to revised international working group criteria for non-Hodgkin lymphoma. (2) Determine the rate of sustained viral response in subjects with low-grade lymphoma.

NCT ID: NCT02712775 Withdrawn - Liver Disease Clinical Trials

Minocycline Administration During Human Liver Transplantation

Start date: March 2016
Phase: Phase 4
Study type: Interventional

Liver transplantation is the sole therapy for end-stage liver diseases and acute liver failure in children and adults. However, use of this life-saving technique is limited due to a severe shortage of donor livers. The number of transplants currently performed is approximately one-third of the number needed to accommodate the more than 16,000 patients awaiting an organ in the US. Over 20% of patients on the liver transplant waiting list die prior to transplantation due to organ shortages. The median waiting time in 2011 was over 300 days. Poor immediate graft function and primary non function (PNF) are clinically significant events, especially in recipients of marginal livers (elderly donors, extended cold storage time, or steatosis). PNF has dramatic effects on patient morbidity and mortality, necessitating prolonged and expensive stays in intensive care units, and re-transplantation is the only life-saving therapy in patients with failing liver grafts due to PNF. This further exerts greater burden on the already scarce donor organ pool. Furthermore, biliary strictures and ischemic cholangiopathy, as a result of severe ischemia reperfusion injury, cause prolonged hospital stay, long-term complications, and increased costs. Targeted treatments, such as the one proposed in this application, will reduce the need for re-transplantation, reduce biliary injury, and potentially increase the number of donor organs available.

NCT ID: NCT02710266 Terminated - Liver Disease Clinical Trials

Evaluation of the Effect of Gabexate Mesilate in the Hepatocyte Protection After Liver Resection

Start date: February 24, 2012
Phase: Phase 3
Study type: Interventional

Liver resection have been a primary treatment option for lesions found in the liver. With improvements in surgical technique and perioperative patient management, morbidity and mortality related to liver resection have been greatly reduced. However, many patients with hepatocellular carcinoma have underlying liver disease. Severity of underlying liver disease plays an important role in decision making of resection extent. Therefore, liver failure and decreased liver function following liver resection still remains to be an critical issue. Postresection liver failure is generally defined by serum total bilirubin greater than 3mg/dL and prothrombin time of less than 50% of normal (INR >1.7). Pathophysiology of postresection liver failure is not yet well known. However, sepsis after liver resection, small-for-size syndrome (SFSS), and ischemia/reperfusion injury are known to have important roles in persistant liver injury after resection. After a liver resection, kupffer cells are drastically decreased and innate immunity of the patient is also damaged. This process causes the patient to be vulnerable to infection. In addition, with continuous endotoxin secretion, dysfunction in kupffer cells are triggered and liver regeneration is affected. Complex mechanisms leading to dysfunctional kupffer cells and apoptosis and necrosis of hepatocytes are mediated by neutrophils, complement, reactive oxygen species, and acute inflammatory cytokines. Recent studies have reported on many promising effects of the synthetic protease inhibitor, such as Gabexate mesilate. These include antioxidant effect, inhibition of acute inflammatory cytokine reaction, and anticoagulatory property. Based on these effects, synthetic protease inhibitor have gained attention in the role of hepatocyte protection after liver resection. Currently, there is a report on the hepatocyte protective effects of Gabexate Mesilate on ischemia/reperfusion injury caused by the Pringle maneuver. However, with the advances in surgical technique and equipment, many surgeons now perform liver resection without Pringle maneuver. Therefore, this study was designed to determine effects of Gabexate Mesilate in the liver resection performed without Pringle maneuver.

NCT ID: NCT02696655 Not yet recruiting - Liver Disease Clinical Trials

Lifestyle Intervention For Liver Transplantation

LIFT
Start date: February 2016
Phase: N/A
Study type: Interventional

(i) To develop a behavioural intervention that supports healthcare professionals to effectively deliver lifestyle behaviour change of patients undergoing liver transplantation (ii) To assess the acceptability and feasibility of the behavioural intervention during routine practice

NCT ID: NCT02686762 Completed - Liver Diseases Clinical Trials

Emricasan, a Caspase Inhibitor, for Evaluation in Subjects With Non-Alcoholic Steatohepatitis (NASH) Fibrosis

ENCORE-NF
Start date: January 26, 2016
Phase: Phase 2
Study type: Interventional

This is a multicenter, double-blind, randomized, placebo-controlled trial involving subjects with a diagnosis of "definite NASH" with fibrosis (excluding cirrhosis) as determined by the central histopathologist. Upon successful screening, subjects will be randomized to receive either emricasan 50 mg BID or emricasan 5 mg BID or matching placebo BID.

NCT ID: NCT02684526 Completed - Liver Disease Clinical Trials

Is Eovist Suitable for Arterial-Phase MR Imaging of Liver

Start date: December 2011
Phase: N/A
Study type: Interventional

To examine the quality of liver images produced when the contrast agent Eovist is used during MRI.

NCT ID: NCT02650115 Completed - Clinical trials for Liver Disease (Alcoholic or Not)

Evaluation of the Involvement of the Intestinal Microbiota and Choline Deficiency in the Severity of Chronic Liver Disease Explored by Analyzing Collection of Biological Samples (MICRONACH)

MICRONACH
Start date: April 6, 2017
Phase:
Study type: Observational

Chronic liver diseases are common and the two main causes in France are NAFLD (No Alcoholic Fatty Liver Disease Nonalcoholic) and ALD (alcoholic liver disease). Because of the importance of the current global obesity, NAFLD has become very common and it is estimated that its prevalence in the general population reaches 20-30%. NAFLD (No Alcoholic Fatty Liver Disease Nonalcoholic) and ALD (alcoholic liver disease) includes a broad spectrum of liver damage, ranging from simple steatosis isolated (infiltration of fat in the liver), in hepatic inflammation, fibrosis (abnormally high accumulation of extracellular components in the functional liver tissue) and finally cirrhosis and its complications. Choline deficiency (essential nutrient generally classified as Class B vitamins) has been associated with liver damage each characterizing NAFLD and ALD. The amount of choline in the body depends in particular on food intake and degradation of choline by the intestinal microbiota. NAFLD and ALD are complex pathologies resulting from the interaction of environmental / nutritional factors and a genetic background. It therefore appears now necessary to study the influence of the relationship between genetic predisposition, environmental factors, and gut microbiota metabolism of choline on the severity of liver injury observed in NAFLD and ALD. If the interaction of these three elements (the host genetics - environmental factors - and intestinal microbiota metabolic choline) has an influence on the severity of the lesions of NAFLD and ALD direct application may be of bring a food supplement choline in patients at risk (mutation of the PEMT gene (phosphatidylethanolamine N-methyltransferase), postmenopausal women, microbiota profile for increased degradation of dietary choline) to restore the amount of choline in the body and thus to avoid a worsening of the ALD or NAFLD and progression to cirrhosis.

NCT ID: NCT02647047 Not yet recruiting - Liver Diseases Clinical Trials

Spinal Versus Epidural Analgesia in Laparotomic Liver Surgery

Start date: January 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the efficacy of spinal analgesia for minor laparotomic hepatectomy compared with epidural analgesia, monitoring visual analog scale (VAS). The investigators expect at least the same post-operative pain control in the two groups (non inferiority of pain control with spinal analgesia compared to epidural analgesia). Second endpoint is to verify whether after spinal analgesia there is a decrease in patient's length of hospitalization according to enhanced recovery after surgery (ERAS) principles.