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Liver Transplantation clinical trials

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NCT ID: NCT02898415 Completed - Clinical trials for Liver Transplantation

Modeling Cancer-specific Prognosis in Liver Transplantation for Hepatocellular Carcinoma (HCC)

AFP-UTS
Start date: June 2015
Phase: N/A
Study type: Observational

Liver transplantation (LT) is one of the curative treatment options for patients with HCC associated to chronic liver disease (cirrhosis). All current international guidelines recommend LT for HCC only within pre-defined criteria The use of restrictive criteria to select patients affected by HCC for LT was originally proposed with the Milan criteria. These criteria were based on pathologic assessment of number and size of the HCC nodules on the explanted liver. Subsequently, many authors proposed the expansion of such restrictive criteria (e.g. UCSF, Tumour Volume, Up-To-Seven etc.). All these attempts, based on different combinations of morphologic parameters, have been defined on the pathologic staging of the tumor made on the removed liver, namely after LT, once decision on treatment and treatment itself could not be changed Although post-LT pathology / pre-LT radiology correlation have improved over time, significant biases still affect clinical assessment of HCC stage and no reliable protocols has entered clinical practice yet. In addition, robust evidence indicates that other biological markers of aggressiveness (such as α-Fetoprotein levels and clinical response to bridge therapies) have to be added when evaluating pre-operative variable Although many studies have been conducted, prognostic calculators of cancer-specific survival for HCC patients undergoing an evaluation for LT are not yet available. Such models should be able to provide survival estimates based on pre-treatment oncologic variables. The main goal of the study is the definition of a cancer-specific prognostic model based on pre-operative features (radiologic staging and α-Fetoprotein levels) of a wide population of patients who underwent LT for HCC. Considering the competitive risk of cancer-specific mortality and death due to other causes, the investigators aim to redefine the Up-To-Seven criteria, as they were developed on the base of pathologic staging

NCT ID: NCT02877628 Completed - Clinical trials for Liver Transplantation

Immunosuppressive Therapy Optimization: Development of a Population Pharmacokinetic-pharmacodynamic (PK-PD) Model in Liver Transplantation

OPTILTH
Start date: October 31, 2015
Phase:
Study type: Observational

Prospective, non-randomized, open Pharmacokinetic-Pharmacogenetic-Pharmacodynamic monocentric study. Donor and recipient CYP3A5 genotype and recipient ABCB1 will not be communicate to clinicians or patients during the study.

NCT ID: NCT02859506 Completed - Liver Transplant Clinical Trials

Eating Behaviour and Gustatory Sensitivity Before and After Liver Transplant in Cirrhotic Patients

GREFFE
Start date: July 3, 2015
Phase: N/A
Study type: Interventional

Today, we know that olfactogustatory alterations occur in cirrhotic patients before the liver transplant but no study has been conducted to show eventual disturbances after the transplantation able to explain modifications in eating behaviour. In parallel, the metabolic status, itself dependent on liver metabolism, influences food preferences and is modified after the transplantation as the liver recovers its ability to store glycogen, but is not able to inform the brain as the afferent nerve impulses have been suppressed. The innovative aspect of this project is to provide information on the importance of the liver in the regulation of energy homeostasis. The results of this study will improve our understanding of eating behaviour and olfactogustatory sensitivity and allow us to orient liver transplant patients towards appropriate diets.

NCT ID: NCT02798861 Completed - Liver Disease Clinical Trials

Controlled Attenuation Parameter (CAP) in Liver Allografts

Start date: September 7, 2016
Phase:
Study type: Observational

The primary aim is to determine the accuracy of CAP in the quantification of liver steatosis using liver biopsies as reference. Secondarily, investigators will correlate transient elastography (TE) and CAP results, analyze possible associations between CAP/TE and post-liver transplant (LT) clinical outcomes, and evaluate the change in CAP after LT. The study aims to include as many donors as needed to achieve at least 120 transplanted liver allografts.

NCT ID: NCT02776553 Completed - Sarcopenia Clinical Trials

A Physical Activity Program in End-state Liver Disease

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

The primary aim of this study is to improve both physical fitness and sarcopenia of patients with ESLD who are potentially eligible for liver transplantation through a 12-week physical training program. Secondary aims will focus on changes in anthropometrics, body composition, quality of life, and metabolic profile. This is a randomized clinical trial including 50 patients, with half allocated to the active group (physical training program) and half to standard of care.

NCT ID: NCT02775162 Completed - Clinical trials for Liver Transplantation

WP01 - Normothermic Liver Preservation

Start date: October 9, 2016
Phase: N/A
Study type: Interventional

A multicenter randomized controlled trial to compare the efficacy of ex-vivo normothermic machine profusion with static cold storage in human liver transplantation.

NCT ID: NCT02761109 Completed - Clinical trials for Liver Transplantation

Postoperative Complications After Liver Transplantation

Start date: January 2011
Phase:
Study type: Observational [Patient Registry]

Incidence and risk factors for renal, cardiovascular and pulmonary complications after liver transplantation are not well defined. Blood products requirement is an important aspect of orthotropic liver transplantation (OLTx) management and has a great impact on patient's outcome. Transfusions of blood products increase perioperative complications and reduce graft and patients survival. The primary endpoint of the study is to evaluate the incidence of renal complication during ICU stay after liver transplantation using RIFLE criteria; secondary endpoint is to evaluate the incidence of cardiovascular and pulmonary complications. In addition patients' survival and the relationship between blood components use with the development of post-operative complications are evaluated.

NCT ID: NCT02740608 Completed - Clinical trials for Liver Transplantation

Viability Testing and Transplantation of Marginal Livers

VITTAL
Start date: October 6, 2016
Phase: N/A
Study type: Interventional

This study is designed to determine if a rejected liver is viable using normothermic machine liver perfusion (NMLP). It aims to 1. establish the suitability of livers which have been declined by all UK liver transplant centres by monitoring their function on the NMLP machine; and, 2. transplant the liver if its function on the machine is satisfactory allowing it to be transplanted.

NCT ID: NCT02739412 Completed - Clinical trials for Liver Transplantation

Efficacy of Low Dose, SubQ Interleukin-2 (IL-2) to Expand Endogenous Regulatory T-Cells in Liver Transplant Recipients

Start date: November 2016
Phase: Phase 2
Study type: Interventional

The purpose of this investigation is to study if very low dose IL-2, given to liver transplant patients by subcutaneous (under the skin) injections, over a 4 week period of time, will cause an increase in the number of Treg cells in the blood.

NCT ID: NCT02736227 Completed - Clinical trials for Liver Transplantation

Biomarkers Predicting Successful Tacrolimus Withdrawal and Everolimus (Zortress) Monotherapy Early After Liver Transplantation

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

Most patients who get a liver transplant must take immunosuppressants for the rest of their lives. However, this has occurred at the expense of chronic CNI toxicity, e.g. chronic kidney disease (CKD), metabolic complications, infections and malignancy. Everolimus (EVL) is a drug that may stabilize or improve kidney function for patients with chronic kidney disease (CKD) that has been caused by immunosuppressants. EVL is used for standard of care treatment to prevent transplant liver rejection in combination with other immunosuppressants, such as tacrolimus. The overall aim of this study is to examine a combination of two different immunosuppressants and EVL to determine if patients may have stabilized and/or improved kidney function without liver rejection. This study will look at how safe it is to slowly withdraw one anti-rejection medication while continuing to take the other medicine, and whether this can be done without liver rejection occurrence.