Cholangitis

Researchers are conducting a long-term observational study to understand how physiological changes in children after biliary tract reconstruction affect their health over time. The study focuses on changes in liver function, metabolism, immune response, and other bodily functions as children grow. It also evaluates the risks these changes might pose for chronic illnesses like cardiovascular disease, diabetes, and liver cirrhosis in adulthood, as well as their effects on cognitive and musculoskeletal health. The goal is to identify early biomarkers that predict future health outcomes and to suggest preventive or intervention strategies to reduce long-term complications. The study follows children diagnosed with biliary atresia or choledochal cyst who have undergone biliary reconstruction surgery. A control group of healthy children matched by age and gender will also be observed for comparison. Researchers will collect samples and data at multiple time points: before surgery, then at 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years after surgery. These data include targeted metabolic components detected in feces and plasma, along with fecal metagenomic sequencing. Participants will be monitored over several years through scheduled assessments to track metabolic and microbiome changes. The study will measure specific metabolic components in fecal and blood samples at each time point to observe ongoing physiological changes. By following both surgical patients and healthy controls, researchers aim to understand the long-term impacts of biliary reconstruction on children's health and identify ways to reduce future health risks. The study enrollment starts in May 2025 and continues until April 2035.

Researchers are evaluating a new, simple breath test that analyzes volatile organic compounds (VOCs) in exhaled breath to help detect liver cancer earlier and monitor liver conditions such as cirrhosis and primary sclerosing cholangitis. This study focuses on adults aged 18 and older who have liver cancer, liver cirrhosis, primary sclerosing cholangitis, or tummy symptoms with a normal liver scan. The goal is to improve early detection and monitoring of liver diseases that are often diagnosed too late for effective treatment. Participants will provide a breath sample after fasting for 6 hours during a one-hour appointment at an NHS hospital. They will also answer health questions and allow access to relevant medical records. The study includes groups of participants with liver cancer, benign liver disorders, and healthy controls with non-specific gastrointestinal symptoms but normal liver scans. There are no treatments or drugs involved as it is an observational study. During the visit, researchers will collect breath samples and health information to measure the diagnostic accuracy of the breath test for detecting liver cancer. The breath collection is non-invasive and safe. Participants will not receive direct health benefits from taking part, but the results may help develop an easier way to detect liver disease in the future. The study is led by Imperial College London and takes place in NHS hospitals across the UK.

Researchers are evaluating the safety and effectiveness of LB-P8 in adults with primary sclerosing cholangitis (PSC), a liver condition. This phase 2, randomized, double-blind, placebo-controlled study involves multiple centers and aims to better understand how LB-P8 works in patients with PSC. The study is sponsored by LISCure Biosciences and includes patients aged 18 to 75 years with specific liver-related criteria. The study has two parts: Part 1 focuses on testing the safety and tolerability of two doses of LB-P8 (a low dose of 1x10^10 CFU per capsule and a high dose of 1x10^11 CFU per capsule) in up to 12 patients. Part 2 compares these two doses of LB-P8 to a placebo in 75 patients randomized equally among the three groups, with treatment lasting up to 24 weeks. Participants will take one oral capsule daily according to their assigned dose or placebo. During the study, participants will undergo various assessments including blood tests to measure liver enzyme levels, liver fibrosis, and other liver function indicators. Researchers will monitor safety, liver disease progression, and the impact of treatment on these measures. The study includes regular visits and evaluations throughout the treatment period, with the goal of understanding both safety and potential changes in liver health over time.

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 studying patients with suspected choledocholithiasis, a condition involving gallstones in the bile duct, who fall into an intermediate likelihood group based on current risk criteria. The study aims to evaluate how a machine learning model can help predict choledocholithiasis and potentially reduce the need for additional diagnostic procedures like Endoscopic Ultrasound (EUS) or Magnetic Resonance Cholangiopancreatography (MRCP). This approach may lower healthcare use and costs for these patients. This observational study uses a machine learning-based predictive model to stratify patients who otherwise might undergo EUS or MRCP. Participants are those aged 18 to 80 years with intermediate risk of choledocholithiasis. The model's performance in predicting the condition will be assessed, focusing on accuracy and receiver operating characteristic curve analysis within one month. Participants will be monitored through diagnostic evaluations including EUS or MRCP as needed, with data collected to validate the machine learning model. Researchers will measure the model's accuracy and compare it to the diagnostic tests. The study will track outcomes over one month, assessing how well the model predicts the presence of choledocholithiasis and its potential to reduce unnecessary diagnostic procedures.

This research aims to evaluate whether normothermic machine perfusion (NMP) can safely increase the number of usable donor livers for transplantation, helping patients get transplants faster and improving outcomes. The study focuses on patients waiting for a liver transplant with a ReMELD-Na-Score of 21 or less, who do not meet certain special exception criteria. It investigates if this new assessment method reduces waiting time and improves survival and health after transplant. Participants are randomly assigned to one of two groups. The experimental group may receive livers initially declined by all German transplant centers but deemed suitable after at least four hours of NMP quality assessment. The control group receives livers through the usual transplant process. Declined livers are selected based on specific quality criteria such as steatosis less than 60%, fibrosis grade up to F3, and graft weight between 1 and 2.5 kg. During the study, researchers track how quickly participants receive a transplant as the main outcome. They also monitor survival rates, disease progression, recovery on the waitlist, quality of life, graft utilization, hospital stay costs, and complications up to 24 months after randomization. Participants will be followed for up to 12 months to observe transplant timing and up to 24 months for longer-term outcomes.

Researchers are evaluating how well neural networks trained on ultrasonic raw radiofrequency data can assess liver diseases in patients undergoing clinical ultrasound exams. The study aims to compare the performance of these neural networks against elastography and those trained on b-mode ultrasound images, as well as to see if they can distinguish focal liver lesions from healthy tissue. This research is conducted with patients who have a clinical indication for elastography or suspected liver lesions and involves collecting detailed ultrasound data for analysis. Participants scheduled for elastography will have both b-mode images and radiofrequency data collected during their ultrasound scans. For those with suspected focal liver lesions, ultrasound data is collected along with a definitive diagnosis obtained through standard clinical procedures such as contrast-enhanced ultrasound, biopsy, MRI, or CT, depending on what is normally done at the participating center. The study includes two groups: one focused on elastography data collection and another on focal lesion evaluation, all without randomization or masking. During the study, participants undergo clinical ultrasound examinations to capture both b-mode images and corresponding radiofrequency data. Additional tests or procedures may be performed to confirm diagnoses for focal liver lesions. Researchers will analyze the performance of the trained neural networks after the study concludes, approximately one year later. The total participation time varies, with assessments aligned to routine clinical care. Safety monitoring includes exclusion of recent liver interventions to avoid confounding results.

This research aims to establish a national cohort in China to study biliary dilatation, a complex benign bile duct disorder common in East Asia. By enrolling patients from 25 medical centers, the study will clarify the disease's epidemiology, pathological features, classification, progression, cancer risk, and the best timing for surgery. It will also compare outcomes among different types of biliary dilatation to develop standardized surgical treatment strategies. The study includes both retrospective and prospective cohorts. Retrospectively, it collects past clinical and prognostic data from previously diagnosed patients. Prospectively, it enrolls newly diagnosed patients and follows them over time to observe outcomes and surgical effects. The focus is on patients with Todani types I, IVa, and V biliary dilatation, analyzing perioperative risks, long-term complications, and quality of life after surgery. Participants will have their demographic, clinical, laboratory, imaging, and biomarker data collected throughout their care. Researchers will monitor disease progression, surgical decision-making, postoperative complications, malignant transformation, and patient quality of life over many years. The primary outcome is the rate of long-term complications after surgery, with secondary outcomes including cancer development and perioperative complications. The study will run through 2035, providing long-term follow-up data.

Researchers are evaluating ways to improve surgical treatment outcomes for liver echinococcosis complicated by biliary fistulas. The study aims to optimize diagnostic methods for early detection of biliary fistulas and improve surgical techniques to better eliminate these complications. This research focuses on refining both the diagnosis and treatment approaches to enhance patient recovery and reduce postoperative issues. The study involves conservative surgical treatment for liver echinococcosis where occult biliary fistulas are identified and managed by applying a U-shaped suture followed by medical cyanoacrylate glue between suture stitches on the fibrous capsule near the fistula. This method is being assessed to determine its effectiveness in managing biliary fistulas during surgery. Participants will be monitored for up to three months after surgery. Researchers will measure the incidence of bile leakage, the time it takes for biliary fistulas to close, treatment costs, and patients' quality of life after surgery. Detailed postoperative data including patient condition, discharge characteristics, complications, and hospital stay duration will be collected to evaluate outcomes and recovery progress.