Liver Transplant

Researchers are investigating the appropriate intensity of rehabilitation programs for patients who have undergone liver transplantation. Cardiovascular disease is a leading cause of death for these patients due to sedentary lifestyle and poor physical fitness after transplant. The study aims to test a structured, home-based, supervised physical rehabilitation and maintenance program in liver transplant recipients, assessing its feasibility, safety, and ability to improve physical fitness. Participants will be randomly assigned to one of three training groups with different exercise intensities low, moderate, or combined moderate and high intensity. The rehabilitation program lasts six months and includes aerobic, strength, balance, and flexibility exercises performed from home under supervision. After this, a 15-month maintenance phase of physical activity tailored to individual preferences will follow to observe long-term implementation. Participants will undergo assessments at the start, three months, six months, and 15 months after the intervention begins. These evaluations include tests of physical fitness, cardiovascular health, liver function, body composition, and questionnaires monitoring well-being, safety, quality of life, physical activity, and cost-effectiveness. Monthly monitoring of adverse events and follow-ups at the study site will ensure safety and track outcomes over time.

This research focuses on kidney transplant patients to collect blood samples and clinical data for developing a non-invasive test that detects donor-derived cell-free DNA dd-cfDNA to assess the condition of transplanted kidneys. The study is prospective and multicenter, involving participants who have had a kidney transplant and are undergoing an indication biopsy. The goal is to improve monitoring of the transplanted organs status. Participants will provide whole blood samples at the time of their indication biopsy, before the biopsy procedure itself. Additionally, leftover de-identified retrospective genomic DNA gDNA samples from the kidney donors will be collected for paired analysis. This approach helps researchers study dd-cfDNA in a real-world transplant population. Participants will be involved through blood sample collection and clinical data gathering during their biopsy visits. Researchers will monitor the detection of donor-derived cell-free DNA in whole blood over an 18-month period. The study involves no investigational treatments, focusing on observation and sample analysis. Participation duration and follow-up details align with the biopsy schedule and sample collection requirements.

Researchers are investigating the use of 18F-DFA PET imaging to evaluate liver injury, a condition involving rapid liver function decline with symptoms like increased liver enzymes, jaundice, and abdominal discomfort. This observational study aims to assess how accurately this imaging method detects liver damage compared to standard clinical biochemical tests and liver biopsy, which is the current gold standard despite its sampling limitations. The study focuses on adults clinically diagnosed with liver damage or liver failure, exploring the correlation between 18F-DFA uptake in the liver and liver function indicators. Participants diagnosed with liver injury will undergo 18F-DFA PET imaging as part of the study. This radioactive tracer, based on vitamin C structure, is used to visualize liver function non-invasively. The imaging process involves a PET-CT scan lasting about 10 minutes, followed by a one-hour waiting period in the examination room before leaving. The study will compare imaging results with clinical liver function tests or liver biopsy findings to determine the sensitivity and specificity of this method. During the study, participants will have their liver function monitored using PET-CT scans and clinical biochemical markers. The primary outcomes include changes in liver uptake values on PET imaging at 6 months and the relationship between imaging results and standard liver function indicators. Participants will be followed up as needed, with assessments including liver enzyme levels and other blood tests. The total study duration depends on individual follow-up, and safety monitoring will address any issues related to PET imaging procedures.

Researchers are collecting data to assess the safety and performance of the da Vinci SP Surgical System, Instruments, and Accessories during hepatopancreaticobiliary HPB and foregut surgeries. These surgeries include cholecystectomy, fundoplication, gastrectomy, distal pancreatectomy, pancreaticoduodenectomy, esophagectomy, and hepatectomy for both benign and malignant diseases. The study is designed as a prospective, single-center investigation focusing on these procedures. Participants will be grouped into four stages based on their diagnosed condition, with each participant undergoing one surgical operation using the da Vinci SP Single-Port Robotic Surgical System. Stage One includes patients undergoing cholecystectomy or hiatal hernia repair with fundoplication. Stage Two involves gastrectomy or distal pancreatectomy. Stage Three covers pancreaticoduodenectomy or esophagectomy, and Stage Four includes hepatectomy. The robotic system is designed to enable minimally invasive single-port surgery through a surgeon console, vision cart, and patient cart with camera and instruments. During the study, participants will be monitored through various assessments including operative time, blood loss, intraoperative and postoperative complications, physical status, survival, disease recurrence, and readmission rates. Follow-up evaluations occur up to five years to track outcomes such as adverse events, positive resection margins, lymph node yield, and overall survival. Participants are followed closely after surgery through hospital discharge and at scheduled intervals to provide comprehensive safety and performance data for the system.

Researchers are evaluating the safety of siplizumab, an investigational anti-CD2 monoclonal antibody, as an induction immunosuppressive treatment in adult patients with autoimmune liver diseases AILD such as autoimmune hepatitis AIH and primary sclerosing cholangitis PSC undergoing liver transplantation. This pilot, open-label phase 1 study addresses the need for effective therapies to prevent immune-mediated graft injury and complications post-transplant. Siplizumab targets memory T cells involved in rejection and autoimmunity after liver transplantation in these patients. Participants will receive two intravenous doses of siplizumab at 0.6 mgkg one dose intraoperatively on the day of transplant Day 0 and another on Day 4 post-transplant. Up to eight subjects will be enrolled. The study lasts about 15 months, including approximately three months waiting for transplant and 12 months of follow-up after transplantation. During the study, participants will be monitored for serious infections within the first month after transplant and for other outcomes such as immune-mediated liver injury, graft loss or death, rejection episodes, donor-specific antibodies, and disease recurrence over 12 months post-transplant. Assessments will include safety, tolerability, pharmacokinetics, and pharmacodynamics of siplizumab, with ongoing observation throughout the study period.

Researchers are evaluating the safety and how the body processes the drug INCB123667 when taken orally by adults with moderate or severe liver impairment. This Phase 1, open-label study includes participants with different levels of liver dysfunction to understand the drugs effects and safety in these groups. Participants are divided into two groups one with moderate hepatic impairment and another with severe hepatic impairment. Each participant receives a single oral dose of INCB123667. The study runs from May 2026 to April 2027, with each participant monitored for up to approximately 2.5 months to assess drug levels and safety. During the study, participants will undergo medical history reviews, physical exams, vital sign checks, ECGs, and lab tests to monitor their liver function and overall health. Researchers will measure drug concentrations in the blood and record any treatment-related side effects. Participants involvement includes signing consent forms and adhering to study protocols, with safety closely tracked throughout the study period.

Robotic surgery is an advanced technology designed to improve minimally invasive liver surgery by enhancing flexibility and precision. This research focuses on comparing robotic liver resection with laparoscopic and open liver resections to evaluate its safety and feasibility. The study aims to provide clear and relevant data about the potential benefits and challenges of using robotic systems in liver surgery. Participants will undergo robotic liver resection using the Da Vinci robotic system. The study compares this approach with traditional laparoscopic and open methods, aiming to assess differences in surgical outcomes. The robotic method is studied as a device intervention, with careful observation of its use in liver tumor removal. Throughout the study, researchers will monitor participants for complications within 90 days after surgery, including hospital stay length, any unplanned reoperations, and readmissions. These outcomes help determine the safety and recovery aspects of robotic liver surgery. Participants will be followed during this postoperative period to gather comprehensive data on their surgical experience and recovery.

Researchers are evaluating the impact of a transitional care model called the Transitional Liver Clinic TLC on patients with advanced liver disease who face challenges after hospital discharge. This trial seeks to reduce early hospital readmissions, improve quality of life, and enhance patient experience during this vulnerable period. The study is designed as a stepped-wedge randomized trial conducted across four large centers over 45 months, including about 1,000 patients with advanced liver disease. Participants will receive either usual care or the TLC intervention. Those in usual care will be followed by their regular providers based on discharge recommendations. Patients in the TLC group will get a phone call from TLC staff within two business days after discharge and an in-person or telehealth clinic visit with a hepatology advanced practice provider within 14 days. Additional care tailored to individual patient needs is provided during the 30-day transitional period. Each site transitions from usual care to TLC sequentially during the study periods. Participants are followed up by phone at 30 and 90 days after discharge to assess outcomes. The study measures include 30-day hospital readmission rates, quality of life using the Promis 292 survey, and patient satisfaction via the PSQ 18 questionnaire. Secondary outcomes include emergency room visits, mortality at 90 days, days alive outside the hospital, and hospital readmissions at 30 and 90 days. The total participation spans the hospitalization and follow-up periods, with close monitoring of patient health and experience.

Researchers are evaluating the safety and effectiveness of abdominal wall transplantation to repair abdominal wall defects. This treatment may be done alone or along with another organ transplant. The study involves a small group of participants and aims to assess how well the transplanted abdominal wall restores function. Participants will receive either an isolated abdominal wall transplant or an abdominal wall transplant combined with another solid organ transplant. All participants will be given standard immunosuppression therapy similar to that used in other non-vascularized composite allograft organ transplants. The study will take place over 18 months at Duke University Medical Center. During the 18-month study period, participants will be closely monitored to see if the transplanted abdominal wall remains viable and functional. Researchers will evaluate the success of the transplant and monitor the participants health and response to treatment throughout this time. The primary measure is the number of subjects with a viable abdominal wall transplant at 18 months.

Researchers are studying liver transplantation in patients with end-stage liver disease caused by Alcohol-Associated Liver Disease AALD. This study evaluates whether adding a specialized addiction intervention after liver transplantation can reduce the rates of alcohol relapse, a common and serious problem that affects long-term survival. The study compares a new approach involving addiction specialists to usual care without such targeted addiction support. Participants are randomly assigned to one of two groups the intervention group receives addiction consultations during hospital stay and follow-up based on their individual risk factors, including motivational interviews and possible medication the control group receives routine transplant center follow-up without systematic addiction specialist involvement. Follow-up visits occur monthly in the first year and bi-monthly in the second year, with addiction referral only if alcohol relapse is detected. The study will monitor participants for two years after their liver transplant hospitalization discharge. Participants will be closely monitored over two years with various assessments including alcohol use relapse timing, tobacco and other substance use, clinical events, liver function tests, alcohol biomarkers, liver fibrosis, cognitive changes, and mortality rates. Researchers will collect detailed data through outpatient visits and laboratory tests to evaluate the effectiveness of the addiction intervention on preventing alcohol relapse and improving long-term outcomes after liver transplantation.