Biliary Tract Disease

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 a new PET imaging tracer called 18FFAPI-74 to detect cancer by targeting the fibroblast-activation protein FAP found in cancer-associated fibroblasts. This study aims to compare 18FFAPI-74 PET scans to the standard 18F-FDG PET scans and other imaging methods like CT or MRI across several cancers including pancreatic ductal adenocarcinoma, cholangiocarcinoma, hepatocellular carcinoma, gastric, bladder, ovarian cancers, pheochromocytomaparaganglioma, small cell lung cancer, neuroendocrine cancer, mesothelioma, and sarcoma. The study is a phase 2 interventional trial conducted by the National Cancer Institute NCI. Participants will receive an intravenous dose of 18FFAPI-74 before undergoing PETCT imaging about one hour later. They will also have a baseline FDG PET scan within one week. If tumors are detected by 18FFAPI-74, additional scans using this tracer and FDG may be repeated during routine treatment and if cancer progresses within two years. Those with negative baseline 18FFAPI-74 scans will not have repeated scans but remain in follow-up. The study involves a single arm where participants undergo both types of PET imaging. During the study, participants will have scans at baseline and potentially at subsequent treatment or progression points. Safety monitoring includes observation for reactions to the tracer up to three days after injection. Researchers will measure the mean number of lesions, standardized uptake values at baseline, post-treatment, and recurrence. Follow-up calls will continue for two years to assess progression-free survival and overall survival. The total participation duration includes imaging visits and two years of follow-up monitoring.

Researchers are evaluating the diagnostic value of a new protein-specific probe called 18F-T2 in PETCT imaging for people with solid tumors that are likely to express high levels of CAIX protein. The study will also assess how safe and tolerable the 18F-T2 injection is, as well as measure its radiation dosage. This research is important to better understand how well 18F-T2 can detect these tumors compared to standard imaging techniques. Participants with tumors suspected to express high levels of CAIX will receive an intravenous injection of 18F-T2. About an hour after the injection, PETCT imaging will be performed to capture detailed images of the tumors. Within one week, participants will also undergo a whole-body PETCT scan using 18F-FDG, a commonly used imaging agent, to allow comparison between the two imaging methods. During the study, participants will be monitored for any adverse events within 24 hours after the 18F-T2 injection to evaluate safety and tolerability. Researchers will measure the diagnostic sensitivity and specificity of 18F-T2 PETCT for detecting CAIX-positive tumors. They will also assess uptake values in tumors on both 18F-T2 and 18F-FDG scans, analyze the correlation between 18F-T2 uptake and CAIX expression in tissue samples, and evaluate radiation dosimetry. The study will continue until one month after completion for outcome assessments.

The GENESIS clinical study aims to map HLA genetic variation in the Greek population and evaluate possible correlations with selected underlying diseases. It is a multicenter, prospective, non-interventional clinical study targeting 12,000 subjects over an anticipated duration of 36 months, with the goal of creating a pilot HLA map for medical research and possible clinical applications. Each subject will complete one visit at a participating site and provide demographic information, including date of birth, gender, race, ancestry, height, and weight, as well as information about smoking or vaping, alcohol consumption, arterial blood pressure, diagnosed diseases, and current treatments. Recent clinical laboratory results from up to 12 months before sample collection may also be collected when available, including blood count, metabolic, liver enzyme, and biochemical parameters. Two buccal swabs will be collected from each subject for DNA extraction and HLA genotyping analysis. Selected DNA samples will also undergo low-pass whole genome sequencing to further investigate associations between the HLA region and autoimmune diseases. After the analysis is completed, an individualized ancestry report will be securely available to study subjects if they elect to access it.

This research aims to describe the clinical, histological, and radiological features of rare primary liver cancers. It focuses on collecting tumor and blood samples to better understand these cancers and to evaluate how well treatments used in real-world practice work, with the goal of identifying the best treatment sequences. The study serves as a foundation for future research to find new molecular and imaging biomarkers that could improve diagnosis and prognosis. The study is observational and retrospective, meaning it reviews past cases from multiple centers in France. It collects biological samples and clinical data from patients diagnosed with rare primary liver cancers after January 2018. The study evaluates treatments patients have received in clinical practice without assigning any new treatments or interventions. Participants data, including clinical characteristics, tumor biology, and imaging, will be reviewed for up to five years from diagnosis. Researchers will measure outcomes such as recurrence-free survival for patients without metastases, progression-free survival for those with metastases, and overall survival. The study includes both living patients who consent to participate and deceased patients, aiming to gather comprehensive information to support future translational studies.

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 childrens health and identify ways to reduce future health risks. The study enrollment starts in May 2025 and continues until April 2035.

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.

Gastrointestinal cancers cause significant health challenges worldwide due to the lack of effective and accessible early screening methods. Current diagnostic tools like endoscopy and imaging are invasive or not sensitive enough for early detection, leading to diagnoses at advanced stages with limited treatment options. Researchers aim to develop a noninvasive blood test using circulating microRNAs miRNAs that may help detect multiple types of gastrointestinal cancers early, improving possible outcomes. This study collects retrospective blood samples from participants with major gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma, pancreatic ductal adenocarcinoma, esophageal squamous cell carcinoma, gastric cancer, and colorectal cancer, as well as from non-cancer controls. Small RNA sequencing will measure circulating miRNA levels. Using machine learning, investigators will identify a minimal panel of miRNAs that can distinguish cancer from non-cancer and differentiate among cancer types across diverse cohorts and geographic regions. Participants blood samples and clinical data will be analyzed to develop and validate this miRNA signature. The study evaluates the accuracy of the miRNA panel for cancer detection using measures like area under the receiver operating characteristic curve and sensitivity. This observational study uses existing samples and data and involves no active treatment. The research aims to create a scalable, cost-effective screening tool to support earlier diagnosis of gastrointestinal cancers.

Frailty is a common condition in older adults that can increase the risk of poor health outcomes such as falls, hospital stays, and death. This research aims to study how assessing frailty before a colonoscopy might affect patient satisfaction and the number of colonoscopies avoided. The study is a prospective randomized controlled trial involving patients over 65 years old at Princess Alexandra Hospital, comparing a personalized approach using a frailty assessment to standard care. Participants will be randomly assigned to one of two groups. One group will receive a personalized approach that includes a frailty assessment using tests like grip strength, sit-to-stand timing, balance, and gait speed, along with questionnaires about medical conditions. The gastroenterologist will discuss the results and risks with the patient to help decide about having a surveillance colonoscopy. The other group will receive standard care, which involves discussing the benefits and risks of colonoscopy without the frailty assessment. During the study, participants will complete satisfaction questionnaires at the time of consultation and within weeks after any colonoscopy procedure. Researchers will track how many patients choose to avoid colonoscopy after receiving information and will monitor colorectal cancer-related complications and other causes of death within five years. The study will assess how the personalized approach may impact decision-making and patient satisfaction with outpatient services related to colonoscopy care.

Researchers are studying how the drug D-2570 is processed in the body and its safety in adults who have liver problems compared to those with normal liver function. This single-center, non-randomized, open-label study evaluates the pharmacokinetic profile of D-2570, focusing on how the drug moves through the body in different participants. The study includes adults aged 18 to 70 years, both with hepatic impairment and healthy liver function. Participants receive a single oral dose of D-2570 during the study. The study is organized into parallel groups, with participants with liver impairment enrolled first, followed by those with normal liver function. Researchers will monitor how the drug is absorbed, distributed, metabolized, and cleared, using blood samples collected up to 192 hours after dosing. During participation, individuals will undergo assessments to measure drug levels and safety, including monitoring for adverse events up to 9 days after dosing. The study tracks several key pharmacokinetic parameters such as time to maximum plasma concentration, maximum concentration, half-life, area under the curve, clearance, and volume of distribution. The entire study is expected to conclude by November 2026, with a primary completion date in October 2026.