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Showing 1-20 of 191 trials
NCT06472973
Transplantation for end-stage-liver disease (ESLD) in the context of Alcohol-Associated Liver Disease (AALD) has been increasing and represents the main indication for Liver Transplantation (LT) in the world. Alcohol Use Disorder (AUD) is considered a brain chronic disease and requires a transdisciplinary approach that includes medical treatment and behavioral interventions. In the context of LT, alcohol relapse occurs in 26 % up to 50% of LT recipients. Among Liver transplant recipients for AALD, severe alcoholic relapse (defined as more than 3 alcoholic drinks per day for women and 4/day for men) after LT leads to impaired longterm survival due to recurrent alcoholic cirrhosis (RAC), cardiovascular events and de novo cancer. Several strategies have been developed to prevent alcohol relapse. After LT, integrating an addiction team into the LT program has been advocated by the latest guidelines in Europe and the United States, in order to bring the management of alcohol-use disorder (AUD) in transplantation units, through the association of psychosocial and pharmacological interventions previously reported in AALD. However, those guidelines were based on descriptive studies, and the effect of this management needs to be confirmed through a randomized, controlled, multicenter study, involving centers that still do not include an addiction team in their LT programs. This study will therefore assess prospectively and comparatively the impact of an addiction intervention after LT on return to alcohol use rates. We hypothesize that standardized targeted addiction monitoring of Liver Transplant recipients decreases the rates of alcohol relapse two years post-liver transplantation.
NCT07631689
Hepatic reperfusion during liver transplantation remains a critical phase associated with significant hemodynamic and systemic disturbances, despite advances in surgical and anesthetic management. This phase is characterized by the release of acidotic, hypothermic, and hyperkalemic blood containing metabolic byproducts and inflammatory mediators resulting from ischemia-reperfusion injury. Clinically, reperfusion is associated with hemodynamic instability, including reductions in cardiac output and arterial pressure, as well as cardiac dysfunction and arrhythmias, often requiring pharmacologic support. These alterations may affect not only immediate intraoperative stability but also short- and long-term outcomes for both the patient and the graft. The abrupt restoration of blood flow to the transplanted liver leads to the systemic release of accumulated metabolites, reactive oxygen species, and inflammatory mediators, contributing to a systemic inflammatory response that may impact distant organs, including the kidneys and heart. Several revascularization strategies have been investigated to mitigate reperfusion-related injury: initial reperfusion via the portal vein, initial reperfusion through the hepatic artery, and simultaneous reperfusion through the portal vein and hepatic artery. A less frequently used and insufficiently studied strategy, not routinely or systematically implemented, involves diverting the initial reperfusion blood from the graft to the surgical field, followed by the restoration of hepatic blood outflow to the systemic circulation. This study hypothesizes that discarding the initial reperfusion blood via the infrahepatic vena cava will attenuate early hemodynamic, metabolic, and inflammatory changes and reduce postoperative complications compared to conventional reperfusion techniques.
NCT07247877
The objective of this observational study is to compare the safety profile of auxiliary liver transplantation using small-for-size grafts with that of conventional liver transplantation and to evaluate the efficacy of this technique. The primary research question it seeks to investigate is: "What are the differences in safety and efficacy between auxiliary liver transplantation utilizing small-for-size grafts and conventional liver transplantation for the treatment of portal hypertension?"
NCT07582978
Liver transplantation (LT) is the standard treatment for hepatocellular carcinoma (HCC) and end-stage liver disease, with excellent long-term outcomes despite the increasing use of extended criteria donors due to organ shortage. As traditional evaluation criteria have become insufficient, new indicators such as Arterial and Biliary Complication-Free Survival (ABCFS) have been developed to better assess post-transplant outcomes. Primary objective: To assess, in a large-scale study, whether the procurement technique influences liver transplantation outcomes in terms of arterial and biliary complication-free survival.
NCT07547020
Hemodynamic instability is a common and serious condition in patients undergoing liver transplantation and is associated with increased morbidity and mortality if not promptly recognized and treated. It results from multiple interacting factors, including blood loss, changes in vascular tone, cardiac dysfunction, and complications related to the surgical procedure. Traditional monitoring strategies focus on global hemodynamic variables such as blood pressure and cardiac output. However, these parameters may not accurately reflect tissue perfusion or oxygen delivery at the microcirculatory level. As a result, patients may appear hemodynamically stable while still experiencing inadequate tissue oxygenation. This study aims to evaluate hemodynamic instability using an integrative physiological approach based on the interaction between different components of the cardiovascular system. Specifically, the study will assess four key interfaces: the relationship between the heart and the arterial system, the coherence between macrocirculation and microcirculation, the interaction between venous return and the right atrium, and the coupling between the right ventricle and the pulmonary circulation. The main objective is to identify distinct hemodynamic profiles in patients during the immediate postoperative period following liver transplantation. In addition, the study will evaluate the incidence of tissue hypoxia within the first 24 hours and its association with clinical outcomes, including 30-day evolution. This is a prospective observational study conducted in adult patients admitted to the intensive care unit after liver transplantation who develop hemodynamic instability requiring vasoactive support. During the first 24 hours, multimodal hemodynamic monitoring will be performed, including assessment of cardiac function, vascular tone, venous congestion, pulmonary circulation, and markers of tissue perfusion such as lactate levels and capillary refill time. By integrating these variables, patients will be classified into different hemodynamic profiles according to the predominant underlying mechanism. This approach aims to improve the understanding of cardiovascular dysfunction in this setting and to support more individualized and physiologically guided management strategies.
NCT06868589
The goal of this clinical trial is to learn if using methadone and ketamine during an adult deceased donor liver transplant can help decrease pain after surgery. The main questions it aims to answer are: * What impact does using methadone and ketamine during a deceased donor liver transplant have on pain after surgery? * Does the use of methadone and ketamine also have an impact on mental confusion (delirium) after surgery? Researchers will compare the use of methadone and ketamine to standard of care to see if the two drugs work to decrease pain and impact delirium after liver transplant. Participants will: * Receive either methadone and ketamine or standard of care during their deceased donor liver transplant. * Allow researchers to follow medical care throughout inpatient stay.
NCT01022476
This phase I/II, multi-center study is designed to determine the pharmacokinetic profile of Raltegravir in patients with end stage liver disease and to assess drug-drug interaction when Raltegravir is combined with immunosuppressive therapy in liver transplant recipients.
NCT07468812
Caregivers of liver transplant recipients often experience substantial physical and psychological demands during the transplantation process. These responsibilities may influence caregivers' fatigue levels, caregiving burden, and physical activity patterns. Understanding these changes is important for protecting caregivers' health and supporting the long-term care process. The aim of this study was to examine changes in fatigue severity, caregiver burden, and physical activity levels among caregivers of liver transplant recipients before and after liver transplantation. A total of 119 caregivers participated in the study. Assessments were conducted at three time points: during the pre-transplant hospital phase, at 90 days after transplantation, and at 180 days after transplantation. Fatigue severity was measured using the Fatigue Severity Scale, caregiver burden was assessed using the Zarit Burden Interview, and physical activity levels were evaluated using the International Physical Activity Questionnaire-Short Form. The findings of this study aim to provide insight into the changes experienced by caregivers during the transplantation process and to contribute to the development of strategies that support caregiver well-being.
NCT07269041
This clinical trial is being conducted to help liver transplant recipients safely discontinue toxic immunosuppressive drugs years after surgery. Lifelong use of these drugs is the current standard, but they come with life-threatening side effects. UCLA has pioneered this "Delayed Tolerance" approach, achieving success in numerous kidney recipients now living drug-free. The process uses a conditioning regimen followed by donor stem cell infusion to retrain the immune system to accept the liver as "self."
NCT07442214
Investigator's aim in this study is to compare the more accessible and low-cost Carotid Doppler USG measurements, which are relatively more difficult to access, costly, and have technical disadvantages, and to demonstrate their superiority over each other in the evaluation of cerebral perfusion in liver transplantation surgeries, without any invasive intervention to the patient.
NCT07425314
This randomized controlled study aims to evaluate the effects of a telerehabilitation-based exercise program on muscle strength, exercise capacity, fatigue level, and cognitive status in adult liver transplant recipients. Liver transplantation is a major surgical procedure, and patients may experience reduced physical capacity, muscle weakness, and fatigue during recovery. Exercise-based rehabilitation may help improve these outcomes, but access to in-person rehabilitation programs may be limited after discharge. Participants will be randomly assigned to either a control group receiving routine post-transplant care or an intervention group participating in a supervised telerehabilitation exercise program. The intervention consists of a 12-week program conducted twice weekly via video communication with a physiotherapist. Outcomes will be assessed at baseline and after completion of the program. The study seeks to determine whether a structured, remotely supervised exercise program can improve functional recovery and reduce fatigue in liver transplant patients, potentially offering an accessible rehabilitation option after hospital discharge.
NCT05428267
The prevalence of erectile dysfunction (ED) is about 10% in the general population, but increases with age, ranging from 9.1% in men 40-49 years to 55% in men \>70. The major risk factors for ED are as follows: diabetes; heart conditions; tobacco use; obesity; injuries to the nerves that control erection; medications such as antidepressants; psychological conditions such as stress, anxiety, or depression; and drug or alcohol use (4). The International Index of Erectile Function (IIEF5) is a simple and well-validated tool for the evaluation of ED (5) and is considered the gold standard for the diagnosis and evaluation of symptom severity. The link between cirrhosis and ED has been suggested in a recent study, showing ED was also impacted by liver failure, portal hypertension and other known risk factors. In the investigators team, they showed, additionally, that neurocognitive impairment is associated with ED in cirrhosis (data not published). The prevalence of ED after liver transplantation (LT) varies among series, ranging from 66 to 86%. After LT, on the one hand, improvement of liver function and bioavailable testosterone favours the improvement of ED. On the other hand, immunosuppressive agents are suspected to worsen it. ED's reversibility has also been discussed; nevertheless, data are scarce and heterogeneous. In the investigators group, they can perform in routine a neurocognitive evaluation of patients with cirrhosis thanks to a neuropsychologist experienced in cognitive disorders occurring in patients with cirrhosis. The aims of this study are: 1) to compare the prevalence of erectile dysfunction (ED) in a population of patients with cirrhosis before liver transplantation (LT) and one year after LT; (2) to describe factors associated with ED before and after LT, with a special focus of hormonal profile, neurocognitive impairment, multimodal brain Magnetic resonance imaging (MRI) and of the type of immunosuppressive therapy used; (3) to assess the impact of ED on sexual partner; (4) to evaluate the efficacy of the treatment with phosphodiesterase-5 inhibitors (PDE-5) drugs after LT. Methods: neurocognitive tests will be performed by an expert neuropsychologist. Biological evaluation will include an evaluation of liver function, hormonal assessment (bioavailable testosterone). MRI acquisition protocol will include anatomical sequences (3D-T1, FLAIR, T2, T2 \*), diffusion tensor imaging (DTI) and two single voxel MR spectroscopy acquisitions. Evaluation will be performed before LT and 1 year after LT.
NCT04551742
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.
NCT07233096
Postoperative pain control plays a crucial role in enhancing recovery and improving early mobilization in living liver donors. The rectus-intercostal fascial plane (RIFP) block is a novel ultrasound-guided regional anesthesia technique that provides anterior abdominal wall analgesia by targeting the intercostal nerves between the rectus abdominis and intercostal muscle fascia. This prospective, randomized controlled clinical study aims to evaluate the postoperative analgesic efficacy and opioid-sparing effects of the RIFP block compared with standard intravenous analgesia in living liver donors undergoing donor hepatectomy. Participants will be randomly assigned to two groups: Group 1 (RIFP Block): Patients receiving an ultrasound-guided rectus-intercostal fascial plane block using 20 mL of 0.25% bupivacaine at the end of surgery, in addition to standard IV PCA (morphine). Group 2 (Control): Patients receiving only standard IV PCA (morphine) without regional block.
NCT07301853
This prospective cohort study aims to identify risk factors for postoperative adverse events in liver transplant recipients and living donors. By collecting comprehensive clinical data and conducting systematic long-term follow-up, the researchers intend to establish a specialized, standardized, and individualized follow-up management system. The ultimate goal is to optimize intervention strategies and improve patient prognosis and quality of life for both recipients and donors.
NCT06717919
Liver transplantation is often performed to treat liver cancer, or hepatocellular carcinoma (HCC), in patients with impaired liver function due to cirrhosis. A shortcoming, however, is tumor recurrence after transplantation. Approximately 15 % of patients receiving livers develop recurrence and this depends on the quality of the liver received. Machine liver perfusion, for example, hypothermic oxygenated liver perfusion (HOPE), which means that the organ is perfused with an oxygen-rich fluid in a cold environment before transplantation, is a novel method to improve the quality of livers before implantation. The standard of care is cold storage without perfusion. The objective of this study is to compare the survival after tumor recurrence of patients after liver transplantation for HCC between perfused and not perfused livers. This study's hypothesis is that survival without tumor recurrence is improved when the liver is perfused before implantation. The study involves transplant centers worldwide, and adults with HCC waiting for liver transplantation are included. 220 Patients will be recruited within 12 months and then observed for at least 2 years after transplantation. To provide the most valid results, the patients will be randomly allocated to either the organ perfusion group or a control group with standard-of-care cold storage of the organ.
NCT07273448
Evaluate the postoperative survival rate and incidence of rejection in patients undergoing ABO-incompatible living donor liver transplantation; analyze the occurrence of secondary endpoint events such as postoperative vascular complications and biliary complications; and explore relevant risk factors affecting prognosis.
NCT01294020
Parts A \& B: Conversion of stable pediatric allograft recipients from Prograf® immunosuppression to Advagraf® immunosuppression to compare exposure and one year follow-up for safety and efficacy. Part C: Continuation of long-term follow-up and provision of ongoing study medication to subjects to whom Advagraf® is currently not available.
NCT03929523
Given the scarce donor supply, an increasing number of so-called marginal or extended criteria donor (ECD) organs have been used for liver transplantation. These ECD liver grafts are, however, known to be associated with a higher rate of early allograft dysfunction (EAD) and primary non-function because of a greater vulnerability to ischemia-reperfusion injury. The end-ischemic Hypothermic Oxygenated Machine Perfusion (HOPE) technique may improve outcomes of liver transplantation with ECD grafts by decreasing reperfusion injury. The study aim is to assess the efficacy of HOPE used before transplantation of ECD liver grafts from brain-dead donors in reducing postoperative EAD within the first 7 postoperative days (POD) compared to simple cold static storage. The study is comparative open-label, multicenter, national, prospective, randomized, in two parallel groups, using the gold standard procedure as control.
NCT07192653
Background: To evaluate the safety and efficacy of intraoperative endovascular treatment (EVT) using the donor ligamentum teres hepatis (LTH) approach for Yerdel grade III/IV portal vein thrombosis (PVT) during liver transplantation (LT), a condition that poses a major challenge in complex surgeries. Methods: This single-center retrospective cohort study included some patients with grade III/IV PVT who underwent LT and were divided into two periods: in both periods, patients underwent modified eversion thrombectomy. However, in Period 1 (2016-2019), nonanatomical anastomosis was performed if portal flow was insufficient, and in Period 2 (2019-2024), patients with persistent hypoperfusion underwent additional LTH-based EVT (stenting or shunt occlusion). Perioperative outcomes (operative time, anhepatic phase, and anastomosis type) and long-term outcomes (graft survival and complication rates) were compared between groups.