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Liver Transplantation clinical trials

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NCT ID: NCT06147648 Not yet recruiting - Clinical trials for Liver Transplantation

Early Conversion of Prolonged-release Tacrolimus in Liver Transplantation.

Start date: December 1, 2023
Phase: Phase 4
Study type: Interventional

Tacrolimus is a commonly used immunosuppressant after liver transplantation. A once-daily administration of prolonged-release tacrolimus has been found to improve patient compliance and offer good efficacy and safety. Moreover, there is evidence that this prolonged-release formulation mitigates renal impairment and metabolic syndrome in transplant recipients. Foreign studies have confirmed that it is safe and feasible for liver transplant recipients to switch from immediate-release tacrolimus to prolonged-release tacrolimus during the stable period. At the same time, patients with early conversion are more likely to benefit in terms of graft survival and renal function recovery, and the proportion of drug conversion needs to be further explored. This study aims to assess the efficacy and safety of switching from immediate-release tacrolimus to prolonged-release tacrolimus three months after liver transplantation. Furthermore, it seeks to investigate the impact of this conversion on indicators such as liver function, kidney function, metabolic disease incidence, and infection incidence in patients.

NCT ID: NCT06147375 Not yet recruiting - Immunosuppression Clinical Trials

Efficacy and Safety of Immunosuppressive Withdrawal After Pediatric Liver Transplantation

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn about the efficacy and safety of immunosuppressive withdrawal in pediatric liver transplant recipients. The main question it aims to answer is:exploring the landscape of immune tolerance after pediatric liver transplantation. Moreover,this clinical trial aims to provide important foundation and clinical data for inducing immune tolerance, as well as to clarify the mechanism of immune tolerance development in pediatric liver transplantation, identify biomarkers that can be used to predict immune tolerance, and build a prediction model of immune tolerance after pediatric liver transplantation. The study planned to enroll 47 recipients after pediatric liver transplantation which would gradually withdrawal immunosuppressive after enrollment, divided the participants into immune tolerance and immune intolerance groups based on the outcome of immunosuppressive withdrawal.In this study, we collect the peripheral blood and liver biopsy samples from the two groups, find biomarkers with predictive value for immune tolerance in recipients after pediatric liver transplantation, and build a predictive model of immune tolerance by machine learning.

NCT ID: NCT06123260 Not yet recruiting - Clinical trials for Liver Transplant; Complications

Renal Outcomes Among Post Liver Transplantation Patients

Start date: December 1, 2023
Phase:
Study type: Observational [Patient Registry]

To evaluate Renal outcomes among patients, post liver transplantation at Assiut university.

NCT ID: NCT06093919 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Study of Prevalence of Eating Disorder in Liver Transplant Patients

Pré-THETA
Start date: February 12, 2024
Phase:
Study type: Observational [Patient Registry]

The main goal of this observational study is to measure the prevalence of binge eating disorder in liver transplant patients by evaluating the responses to the Bulimia Test. Secondary objectives of the study are to: - Determine the prevalence of binge eating disorders in liver transplant patients following alcoholic cirrhosis, evaluated by the Bulimia Test; - Study the association between the presence of eating disorder behaviours and liver damage : hepatic steatosis and fibrosis determined by Fibroscan (Transient elastography and controlled attenuation parameter) - Study the association between presence of eating disorder behaviours and alcohol use disorder, measured by Alcohol Use Disorders Identification Test-Consumption

NCT ID: NCT06088758 Not yet recruiting - Liver Transplant Clinical Trials

Normothermic Machine Perfusion of Steatotic Livers for Expansion of Donor Organ Pool

Start date: November 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to assess the ability of Normothermic Machine Perfusion (NMP) to resuscitate moderately steatotic livers for transplantation in patients. This will be a single-site clinical trial placing donor livers with 30-60% macrosteatosis on NMP, and then transplanting those that meet commonly accepted viability criteria. The results of this study could lead to a trial extending NMP transplantation to severely steatotic livers, further expanding the donor organ pool.

NCT ID: NCT06048445 Not yet recruiting - Clinical trials for Liver Transplant; Complications

Placement of Biliary Drainage Stent to Prevent Biliary Intestinal Anastomosis After Liver Transplantation in Children

Start date: October 1, 2023
Phase:
Study type: Observational

Liver transplantation is an effective method for treating end-stage liver disease and metabolic diseases in children. With the advancement of surgical techniques and the improvement of perioperative management, the survival rates of patients and grafts after liver transplantation have significantly improved. However, the complication of biliary stenosis after transplantation is as high as 7.3% -33.3%, and in severe cases, it can even lead to graft failure and patient death. Therefore, the occurrence of biliary stenosis after liver transplantation seriously affects the quality of life of children, increases the economic burden on families, and urgently needs to find effective methods to reduce the occurrence of this complication. Based on the clinical practice of our center, we believe that the placement of biliary external drainage stents has the following advantages: 1 Reduce intrahepatic biliary pressure and reduce the occurrence of postoperative biliary fistula; 2. The stent has a supporting effect and can maintain the open state of the bile duct; 3. By external drainage, the quality of bile secretion by the liver can be evaluated; 4. Provide a pathway for cholangiography. However, placing external biliary drainage may also pose certain risks, including increasing surgical procedures, stent detachment causing biliary fistula, and increasing the risk of infection. This study aims to observe the effect of placing external biliary drainage stents on biliary stricture after liver transplantation in children. The aim is to evaluate the preventive effect of external biliary drainage stents on biliary intestinal anastomotic stenosis after liver transplantation in children, and to provide evidence-based evidence for reducing biliary complications in children.

NCT ID: NCT06041490 Not yet recruiting - Clinical trials for Liver Transplant; Complications

Adjuvant Therapy for High-risk Hepatocellular Carcinoma Post Liver Transplantation

Start date: September 2023
Phase: Phase 2
Study type: Interventional

1. Explore the impact of postoperative administration of multi-kinase inhibitors (including sorafenib, lenvatinib, and regorafenib) in conjunction with bevacizumab on post-transplant recurrence, overall survival, and drug safety in liver transplant recipients at high risk of recurrence in hepatocellular carcinoma. 2. The primary objective of this study is to evaluate the efficacy of multi-kinase inhibitors in combination with bevacizumab as adjuvant therapy in liver transplant recipients with hepatocellular carcinoma who present high-risk factors for recurrence, based on the one-year recurrence-free survival rate (1-year RFS rate). 3. The secondary objectives of this study are to assess the effectiveness and safety of multi-kinase inhibitors in combination with bevacizumab as adjuvant therapy in liver transplant recipients with hepatocellular carcinoma who present high-risk factors for recurrence, based on the following parameters: Recurrence-free survival (RFS) duration, Overall survival (OS), Two-year and three-year RFS rates, Graft survival, Quality of life evaluation (QoL), Incidence of adverse events and serious adverse events.

NCT ID: NCT06014320 Not yet recruiting - Liver Cirrhosis Clinical Trials

Alterations in Coagulation Factor Levels in Patients With End Stage Liver Disease

Start date: October 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about the changes in coagulation factor VIII and IX levels in patients undergoing liver transplantation to help guide future management of coagulation factor replacement in patients with hemophilia and liver disease. The question we aim to answer is: should the recommendations for factor replacement in patients with hereditary bleeding disorders be altered in the setting of end stage liver cirrhosis? Participants will be asked to provide two blood samples, one at the beginning of their liver transplant, and one after their liver transplant.

NCT ID: NCT05953948 Not yet recruiting - Quality of Life Clinical Trials

Effectiveness of Intelligent Case Manage Platform in Liver Transplant Recipients

ICMP
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

This study is a prospective, quasi-experimental design, with an experimental group and a control group, will be created. The aims of this study are as follows: 1. Describe the self-management and information needs of liver transplant recipients, 2. Create content or modules related to the self-management of liver transplant recipients, 3. Build an intelligent case management platform, 4. Evaluate the usability of the platform, and 5. Conduct deep learning and examine the effects of the intelligent case management platform on self-efficacy, self-management, health outcomes, and health-related quality of life. Data will be collected at discharge (baseline data) and 1, 3, 6, 9, and 12 months after discharge. An estimated 133 patients will be involved in this experiment: 44 in the experimental group and 89 in the control group. Statistical package software (SPSS 22.0) will be used to analyze the data. A generalized estimation equation model will examine the differences in self-efficacy, self-management, and health-related quality of life between the experimental and control groups. Survival analysis and the Kaplan-Meier method will be used to analyze health outcomes, including hospital readmission, emergency visits, episodes of infection and rejection of organs, and death.

NCT ID: NCT05951231 Not yet recruiting - Liver Cancer Clinical Trials

Liver Transplantation After ex Vivo Liver Perfusion

EVOLVE
Start date: February 2024
Phase: N/A
Study type: Interventional

Today, it is difficult to predict liver function after transplantation and therefore livers where poor function is assumed (marginal livers) become discarded. The study aim is to increase the number of available donor livers, especially for liver cancer patients, by pre-treating and testing marginal ones (extended criteria donor (ECD) livers) liver on a liver perfusion machine. A liver perfusion machine can simulate liver transplantation and enables functional/quality testing before transplantation. The machine will hopefully also make marginal livers more functional by reducing ischemia- & reperfusion injury. A marginal donor liver is perfused ex situ with oxygenated blood from a blood donor on a machine. The liver can be tested here for function using internationally recognized criteria. At the same time, the investigators will carry out analyzes with microdialysis which can give a better picture of organ function and damage. Additionally, various samples of the liver and perfusate will be collected. Liver that achieves criteria for transplantation will be offered to the recipient.