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 organ's 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 evaluating the safety and performance of the da Vinci SP Surgical System, Instruments, and Accessories in hepatopancreaticobiliary (HPB) and foregut surgeries. These operations include cholecystectomy, fundoplication, gastrectomy, distal pancreatectomy, pancreaticoduodenectomy, esophagectomy, and hepatectomy for both benign and malignant diseases. The study aims to collect data on the system's use in these complex surgical procedures at a single center. The study is divided into four stages based on the participant's diagnosis and the type of operation. Each participant will undergo one operation using the da Vinci SP-assisted Single Port Robot. Stage One involves cholecystectomy and hiatal hernia repair with fundoplication. Stage Two includes gastrectomy and distal pancreatectomy. Stage Three covers pancreaticoduodenectomy and esophagectomy. Stage Four involves hepatectomy. The da Vinci SP system uses a minimally invasive single-port approach with a surgeon console, vision cart, patient cart, camera, instruments, and accessories. During the study, participants will be monitored for completion of surgery using the planned robotic system, intraoperative and postoperative adverse events, positive resection margins, and lymph node yield over periods up to 24 months. Additional assessments include physical status, comorbidity scores, operative time, blood loss, complications, mortality, discharge date, survival, disease recurrence, and readmission rates. Follow-up extends annually through five years to evaluate long-term outcomes and safety. Participants will be observed closely to collect comprehensive surgical and recovery data.

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 mg/kg: 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.

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 29+2 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 evaluating the impact of addiction-focused interventions on liver transplant recipients with Alcohol-Associated Liver Disease (AALD). This trial investigates whether targeted addiction monitoring after liver transplantation can reduce alcohol relapse rates, which affect long-term survival and health outcomes. It addresses the high relapse risk post-transplant and aims to improve management by comparing standard care with specialized addiction support. Participants are randomly assigned to one of two groups: an interventional group receiving specialized addiction consultations using the BRENDA method, where risk factors for relapse guide the intensity of follow-up and possible pharmacological treatment; and a control group receiving routine liver transplant follow-up without systematic addiction specialist involvement. The intervention includes outpatient motivational interviews every 4 weeks or consultations every 6 months, with hospitalizations if relapse risk is high. During the study, participants are monitored for two years following their liver transplantation hospital discharge. Researchers assess alcohol relapse timing and severity, tobacco and other substance use, addiction treatments received, clinical events, liver function tests, biomarkers of alcohol consumption, liver fibrosis, cognitive changes, and mortality related to alcohol. Follow-up visits and evaluations occur regularly to track these outcomes and the effectiveness of the addiction intervention.

Researchers are studying liver transplantation in patients with liver cancer or end-stage liver disease who receive grafts from extended criteria donors (ECD). These donors have factors that increase the risk of complications like primary non-function or early graft dysfunction due to greater susceptibility to injury during transplantation. The study aims to evaluate whether using a temporary porto-caval shunt (TPCS) during the transplant surgery can reduce these risks by preventing blood congestion and inflammation in the gut. Participants are randomly assigned to one of two groups: those who receive the temporary porto-caval shunt during the transplant surgery and those who do not. The shunt is created by connecting the portal vein to the vena cava during the phase when the liver is removed. This procedure is intended to reduce damage during the operation. The study measures outcomes such as early graft function and complications within the first week after surgery. During the study, researchers will monitor liver function and complications up to three months after transplantation. They will assess early allograft dysfunction and primary non-function within the first seven postoperative days, along with surgery duration, transfusions, reperfusion syndrome shortly after blood flow restoration, urinary function, and survival of both graft and patient. Participants will be followed closely during this time to evaluate the effects of the shunt on transplant outcomes.