Jaundice

Researchers are evaluating new strategies for preoperative biliary drainage in patients with resectable pancreatic head cancer who have severe obstructive jaundice. This trial compares a modified drainage approach using serum prealbumin levels as the main evaluation marker against the traditional approach relying on serum total bilirubin levels. The study aims to determine the impact of these strategies on in-hospital complications and long-term outcomes, providing evidence to guide clinical decisions on drainage timing and surgery scheduling. Participants will be randomly assigned to one of two groups: one receiving the traditional preoperative biliary drainage strategy based on total bilirubin, and the other receiving the modified strategy based on prealbumin levels. Both groups will undergo endoscopic biliary drainage (ERCP) prior to radical pancreaticoduodenectomy surgery. The study is multicenter, open-label, and controlled, with treatment and evaluation occurring before surgery. During the study, patients will be monitored for complications during hospitalization up to three months after treatment. Researchers will also track recurrence or metastasis, mortality, and long-term complications up to 12 months after discharge. Assessments include clinical evaluations and laboratory measurements to monitor drainage effectiveness and patient safety. The total duration of participation includes preoperative evaluation, treatment, and follow-up over one year to assess outcomes comprehensively.

Researchers are investigating the relationship between the volume of normal liver tissue removed during surgery, called resected normal liver parenchymal volume (RNLV), and the risk of liver failure after liver surgery (post-hepatetotomy liver failure, or PHLF). This observational study focuses on patients diagnosed with hepatocellular carcinoma (HCC) or intracholangiocarcinoma (ICC) who have undergone liver resection. The goal is to build and assess a personalized predictive model using RNLV to better estimate the risk of PHLF before surgery. The study collects data retrospectively from over a thousand patients treated at the investigator’s center. Patients are grouped based on whether they developed liver failure after surgery, defined by two sets of criteria known as the 50-50 criteria and ISGLS criteria. The research evaluates how well the RNLV-based model predicts PHLF and compares its usefulness to other methods, especially for patients with large or multiple liver tumors. Participants' medical records and surgical details are reviewed to calculate RNLV and assess liver failure outcomes within 30 days after surgery. The main outcome is the predicted probability of PHLF using the newly developed model. This approach aims to improve preoperative risk assessment to support safer liver surgeries. The study is sponsored by the National Natural Science Foundation of China and runs through the end of 2026.

This observational study focuses on liver transplant patients who are taking tacrolimus-containing medications. It aims to compare the pharmacokinetic parameters of different tacrolimus products and examine their relationships to liver function, kidney function (estimated glomerular filtration rate), and patient adherence. The study also monitors the occurrence of acute graft rejection and infections such as BK and cytomegalovirus during the observation period. This research addresses the lack of real-life data on immunosuppressive drug effectiveness and safety in liver transplant patients across Europe. Participants are liver or simultaneous liver-kidney transplant recipients aged 18 years or older who have been on tacrolimus-containing immunosuppressant therapy for at least four weeks before joining. Various tacrolimus medications, including Envarsus, Adport, Advagraf, Modigraf, Prograf, and Tacforius, are used under routine clinical care following local dosing guidelines. The study observes patients over a 24-month period without changing their prescribed treatments. During the study, participants undergo routine clinical visits and tests as part of their standard care, with no additional procedures required. Researchers collect data on tacrolimus blood levels, daily doses, and their variability, alongside liver and kidney function tests. Adherence is assessed using the BAASIS questionnaire and electronic health records of prescription fills. Outcomes such as graft rejection, infection rates, and drug tolerability are evaluated over 12 months, with ongoing monitoring for up to two years.

This research investigates the relationship between bilirubin metabolism and metabolic health by comparing individuals with Gilbert's syndrome (GS) to healthy controls. The study focuses on energy metabolism, body composition, and the activity of brown adipose tissue (BAT) in these two groups. Researchers aim to understand why people with GS show a distinct metabolic profile linked to mildly elevated bilirubin levels and its potential health effects. Participants will undergo several diagnostic procedures over three separate days. These include cold exposure to stimulate brown fat, PET-CT imaging to assess BAT, MRI scans of the liver, abdominal fat, and muscle, blood sampling, indirect calorimetry to measure energy expenditure, bioelectrical impedance analysis for body composition, and infrared thermography. The study groups consist of 40 individuals with GS and 40 matched controls based on age and gender, distinguished by their bilirubin blood levels. Each participant will attend three study days involving fasting before key measurements. On the first day, brown adipose tissue activity is measured; on the second day, fat distribution in the liver and muscle is assessed. Participants also complete dietary and physical activity questionnaires. The primary outcome is the activation of brown adipose tissue induced by cold over 12 hours across the three days. Researchers will monitor metabolic health, body composition, and BAT activity to compare GS individuals with controls. The study is conducted by the Medical University of Vienna and lasts approximately three days per participant.

About 50% of full-term newborns and 80% of premature infants develop jaundice which is due to hyperbilirubinemia. In the majority of cases, jaundice disappears naturally without treatment within three weeks of birth, but the bilirubin level may remain too high, which can lead to a serious neurological disease: kernicterus. To avoid this, a therapeutic management must be instituted, and in some cases, one or more phototherapy sessions (PT) may be prescribed. The aim of this trial is to evaluate the safety and level of satisfaction of parents and healthcare team with one innovative device for phototherapy BUBOLight® included two removable strips of luminous textile incorporating optical fibers. 10 newborns requiring phototherapy, will be illuminated during four hours in one session of PT Bilirubin levels is taken at the start of phototherapy H0 and Controls are made at H+6 hours.

Researchers are conducting a retrospective study to analyze complications following hepatectomy, a key surgical treatment for liver diseases like liver cancer, hepatic hemangiomas, and biliary stones. While hepatectomy has shown significant benefits, postoperative complications such as liver failure, hepatic vascular thrombosis, wound infections, and bile leakage remain serious concerns that threaten patient health and increase treatment costs. Prior studies have mostly focused on isolated complications with small patient groups, lacking a comprehensive overview. This observational study uses diagnostic criteria from the International Study Group for Liver Surgery (ISGLS) to identify liver failure occurring on or after the fifth day following surgery. The study groups patients into those who experienced post-hepatectomy liver failure (PHLF) and those who did not, as well as patients with and without liver cirrhosis. The research collects data retrospectively from patients who underwent liver resection surgery at participating centers. Participants' medical records will be reviewed to assess the incidence and risk factors of complications after hepatectomy. The primary outcome is the occurrence of liver failure after surgery, with mortality evaluated within 30 days post-operation. The study aims to provide clinical doctors with better guidance on preventing and managing postoperative complications by analyzing a large patient sample. The study includes adults aged 18 to 80 years who had liver surgery and excludes patients with prior cancer treatments, repeat surgeries, other malignancies, severe concurrent diseases, or incomplete data.

This research aims to evaluate the use of the COMBO Endoscopy Oropharyngeal Airway device to reduce the occurrence of low oxygen levels (hypoxia) during sedation for patients undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP). The study targets patients with conditions such as choledocholithiasis with cholecystitis with obstruction, obstructive jaundice, pancreatitis, and cholelithiasis. It is conducted under phase 2 clinical trial conditions to explore this new device's role in improving patient safety during the procedure. Participants will use the COMBO Endoscopy Oropharyngeal Airway, a multifunctional device designed to provide oxygen support, protect the airways, and monitor breathing during sedated ERCP procedures. The device integrates capnography monitoring, bite block protection, oxygen delivery, and airway management tailored specifically for endoscopic procedures. This device group represents the experimental arm of the study. During the hospital stay, expected to last about 2 hours, patients will be closely monitored to measure the frequency of hypoxia, sub-clinical respiratory depression, and severe hypoxia. Researchers will observe and record these breathing-related outcomes throughout the procedure and recovery. The study includes safety evaluations and continuous monitoring to assess the device's impact on patient oxygen levels during sedation.

Acute cholangitis is a serious infection of the biliary system caused by blockage and infected bile, which can quickly lead to sepsis if untreated. Researchers are evaluating whether adding intraductal antibiotics during endoscopic retrograde cholangiopancreatography (ERCP) improves outcomes for patients with acute cholangitis compared to standard systemic antibiotic therapy alone. This study is a phase 2 randomized controlled trial assessing the efficacy and safety of this approach. Participants will undergo ERCP where they are randomly assigned to receive either 20cc of distilled water (control) or 20cc of intraductal antibiotic Gentamicin 80mg diluted in distilled water (study arm) during the procedure. In both groups, the endoscopist will flush the bile duct with the assigned solution before placing a biliary stent or removing the catheter. All patients will continue receiving standard systemic antibiotic therapy alongside the study intervention. Throughout the study, participants will be closely monitored for symptom resolution and improvements in inflammatory markers and liver function tests from admission through Day 3 after ERCP. Researchers will also track hospital stay length, duration of intravenous antibiotics, and any complications during and after the procedure. The trial aims to measure the local antibiotic's effect on infection control and safety over approximately one month of hospitalization.

Researchers are evaluating the use of ex vivo CRISPR-Cas9 genome editing on donor liver grafts to reduce immune rejection in patients with end-stage liver disease or acute liver failure. The study aims to create a "hypoimmunogenic" liver by knocking out HLA-A and HLA-B genes and disabling HLA class II expression through targeting the CIITA gene. This trial focuses on assessing the safety, feasibility, and immune response reduction of CRISPR-edited livers transplanted into patients. In this trial, deceased-donor livers undergo gene editing outside the body during machine perfusion using a CRISPR-Cas9 complex targeting HLA-A, HLA-B, and CIITA genes. The edited liver, confirmed for successful gene knockout, is then transplanted using standard surgical methods. Participants receive routine immunosuppressive therapy after surgery, with planned adjustments based on their response and graft immunogenicity. The study does not include a comparator group but compares outcomes to historical data of unedited liver transplants. Participants will be monitored closely with frequent visits to assess safety, graft function, immune response, and transplant rejection over time. Primary outcomes include adverse events, gene editing feasibility, and graft failure within 90 days. Secondary measures evaluate acute rejection, immune markers, graft survival, patient survival, immunosuppression reduction, and off-target effects up to 24 months. Long-term follow-up includes biopsies and immune monitoring, and participants are expected to comply with study procedures throughout the observation period.

Hyponatremia, a common electrolyte imbalance in hospitalized patients, is classified into hypovolemic, euvolemic, or hypervolemic types. The syndrome of inappropriate antidiuresis (SIAD) often causes euvolemic hyponatremia, while congestive heart failure and liver cirrhosis are common causes of hypervolemic hyponatremia. Current treatments, including fluid restriction, have limited effectiveness. Researchers are evaluating the SGLT2 inhibitor empagliflozin (Jardiance) for its potential to increase serum sodium levels in these conditions through a randomized, placebo-controlled trial. Participants will receive either empagliflozin 25 mg or a placebo once daily by mouth for 30 days. The study is double-blind and randomized, comparing empagliflozin's effects without additional fluid restriction. The trial aims to assess the impact of the drug on serum sodium concentration and other related measures over both short-term (4 days) and longer-term (30 days) periods. During the study, participants will undergo regular assessments including measurements of serum sodium, body weight, blood pressure, plasma and urinary markers, and various health and well-being indicators such as cognitive function, quality of life, and occurrence of symptoms like thirst or headache. Safety and clinical outcomes like hospital stay length will also be monitored. The total participation duration is 30 days, with detailed monitoring throughout this period.