Jaundice

Researchers are evaluating two types of 12-mm self-expandable metallic stents for treating adults with unresectable malignant distal biliary obstruction, a condition caused by cancers such as pancreatic cancer and cholangiocarcinoma. This clinical trial aims to compare the effectiveness and safety of partially covered versus bare metallic stents, as it is unclear which stent type better prevents recurrent biliary blockage and reduces complications. The study is prospective, randomized, and single-center, focusing on patients who have already undergone percutaneous transhepatic biliary drainage PTBD. Participants will be randomly assigned to receive either a 12-mm partially covered or a 12-mm bare metallic stent, both placed through the existing PTBD tract using a percutaneous transhepatic approach. The stent placement will be followed by careful monitoring. The trial includes two groups one receiving the partially covered stent ComVi Biliary Stent and the other the bare stent Niti-S Biliary Uncovered Stent. The study will follow participants for 12 months after stent placement, with assessments at 3, 6, and 12 months. Throughout the study, participants will undergo evaluations to measure the cumulative incidence of recurrent biliary obstruction, stent patency duration, reintervention rates, overall survival, and procedure-related complications such as pancreatitis, cholecystitis, bleeding, perforation, and cholangitis. These assessments involve imaging and clinical follow-up visits. The outcomes will help guide the choice of the most suitable 12-mm metallic stent for patients with this condition, supporting better treatment decisions over a one-year period.

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 investigators 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 Gilberts 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.

Neonatal jaundice affects about half of full-term newborns and up to 80% of premature infants, caused by high bilirubin levels in the blood. While jaundice often resolves naturally within three weeks, elevated bilirubin can lead to serious brain disease called kernicterus. This trial aims to evaluate the safety and satisfaction of parents and healthcare staff using a new phototherapy device called BUBOLight, which uses luminous textile strips with optical fibers to treat newborn jaundice. The study involves 10 newborns requiring phototherapy who will receive one 4-hour session of phototherapy using the BUBOLight device. Bilirubin levels will be measured at the start of treatment and six hours later. The device is being evaluated as a new treatment approach for managing jaundice in newborns. Participants will be monitored for adverse events during and after phototherapy at baseline, 2 hours, and 4 hours. Additional assessments include blood and skin bilirubin levels, newborn pain and discomfort scores, and feedback from parents and healthcare providers about the device. The study is conducted until December 2026, with safety and satisfaction as key outcomes.

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 devices 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 devices 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 antibiotics 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 empagliflozins 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.