Esophageal Varices

Researchers are studying the use of spleen shear wave elastography (SWE-SSM) to help diagnose significant portal hypertension and high-risk esophageal varices in patients with advanced compensated chronic liver disease. The study aims to understand how well SWE-SSM can identify these conditions without affecting patient treatment or disease progression. It also explores how SWE-SSM relates to portal pressure and transient elastography measurements in some patients. During the ultrasound exams that patients normally undergo, spleen elastography will be added if the patient meets study criteria and consents. This additional test is non-invasive and does not change the standard ultrasound procedure or patient care. No treatments or experimental interventions will be given, as the study focuses on collecting clinical data through observation. Participants will have ultrasound exams including both spleen and liver elastography as part of their usual care pathway. Researchers will evaluate measurements related to portal hypertension and esophageal varices over a two-year period. The study monitors the natural course of the disease and gathers data without altering treatments or clinical management.

Researchers are investigating new non-invasive methods to predict hepatic venous pressure gradient (HVPG), a key measure in managing portal hypertension in cirrhosis. This study compares three-dimensional magnetic resonance elastography (3D-MRE) with two-dimensional magnetic resonance elastography (2D-MRE) to develop a risk stratification system that can guide personalized treatment for portal hypertension. Cirrhosis and portal hypertension pose significant health challenges, making less invasive diagnostic tools important for patient care. Participants will undergo imaging using either 3D-MRE or 2D-MRE, both performed on a 3.0-T MRI system with an eight-channel body coil. The study features two groups: one developing a model using 3D-MRE and a control group using 2D-MRE. Hepatic venous pressure gradient measurements are taken by trained radiologists following standard procedures. Comparing these imaging techniques aims to evaluate their accuracy in assessing portal hypertension. During the study, participants will have imaging and HVPG measurements within one month to ensure data consistency. Researchers will assess the accuracy of 3D-MRE and 2D-MRE features for predicting portal hypertension over a 12-month period. The study monitors participants through these diagnostic tests and evaluates how well the imaging models can predict HVPG, contributing to safer, more convenient management of cirrhosis-related complications.

Researchers are evaluating a new, non-invasive method using three-dimensional magnetic resonance elastography (3D-MRE) to predict hepatic venous pressure gradient (HVPG) in patients with cirrhosis, portal hypertension, or advanced chronic liver disease. This study aims to establish a risk stratification system to better manage portal hypertension, a critical factor affecting the prognosis of these liver conditions. The trial is observational and focuses on improving diagnosis without invasive procedures like liver biopsy or traditional HVPG measurement. The study involves two groups: a training cohort to develop the new 3D-MRE model for virtual HVPG prediction, and a validation cohort to confirm the model's accuracy in different patients under similar conditions. Imaging is done using a 3.0-T MRI system with a phased-array body coil, while HVPG measurements are performed by skilled interventional radiologists following standard procedures. Participants undergo both assessments within one month. During the 12-month study, participants will have their portal hypertension assessed through the features of 3D-MRE and HVPG readings. Researchers will analyze the accuracy of 3D-MRE to predict portal hypertension levels. Participants provide informed consent and meet age and health criteria. The study includes monitoring to ensure reliable imaging and measurement results, with exclusion of those with conditions or treatments that may affect accuracy. The total participation involves these diagnostic steps, with no treatment interventions administered.

Researchers are conducting a prospective, single-center, randomized controlled trial to study patients with acute necrotizing pancreatitis (ANP) complicated by pancreatic sinistral portal hypertension (PSPH). The trial aims to evaluate how total splenectomy affects the effectiveness of debridement surgery, recovery during the perioperative period, and the overall prognosis for these patients. This study plans to enroll 66 participants and compares two surgical approaches to better understand their impacts on patient outcomes. Participants will be randomly assigned to one of two groups: one receiving open debridement combined with distal pancreatectomy and total splenectomy, and the other receiving open debridement alone. The study will observe differences in recovery and prognosis between these two surgical methods, focusing on hospital stay length, treatment costs, life quality after surgery, and improvement in PSPH. Secondary outcomes include monitoring infection control, antibiotic use, drainage management, platelet count changes, and the frequency of additional operations or readmissions. During the study, participants will be closely monitored from enrollment until up to five years after surgery. Researchers will track hospital stay durations, intensive care unit time, and complications like pancreatic fistula. Life quality will also be assessed up to one year after treatment. Data on postoperative costs, drainage tube removal, antibiotic use, and abdominal lavage will be collected to evaluate surgical recovery. This comprehensive follow-up will help assess the overall impact of the surgical options on patient health and recovery.

Researchers are observing the safety of damoctocog alfa pegol, a medicine used to treat hemophilia A, a genetic bleeding disorder caused by missing clotting factor 8 (FVIII). This study focuses on Korean participants who are at least 12 years old and have previously used other hemophilia A treatments. The main goal is to learn more about the safety of this medicine when used in routine medical care. Participants receive damoctocog alfa pegol as prescribed by their doctors following usual clinical practices. The study does not provide the medicine directly, and no changes to healthcare or additional treatments are made for study purposes. Data collection happens continuously during a 36-week period as participants continue their regular clinic visits. During the study, researchers collect data from participants' health records and routine care without requiring extra visits or tests. They monitor for any medical problems, including adverse events, serious adverse events, and reactions related to the treatment. The study tracks bleeding episodes, medicine usage, and treatment choices over about eight months for each participant, providing real-world safety information.

Researchers are investigating the albumin bilirubin index to predict the risk of recurrent bleeding within three months after endoscopic treatment in patients with cirrhosis and esophagogastric variceal bleeding (EGVB). The study aims to clarify how well this index can forecast bleeding outcomes, which may help guide future care for affected patients. The research is observational and sponsored by Assiut University. Participants will be observed following their endoscopic treatment without receiving additional experimental interventions. The study focuses on monitoring patients over time to evaluate the relationship between their albumin bilirubin index levels and bleeding recurrence. No specific treatments or procedures beyond standard care are assigned by the study. During the study, participants' health and bleeding status will be regularly assessed to track the prevalence of variceal bleeding in those with a high albumin bilirubin index over six months. Data collection will include clinical evaluations and laboratory tests as part of routine care. The study duration and follow-up are structured to gather meaningful information on this predictive marker's value.

Researchers are evaluating the combination of Anlotinib Hydrochloride Capsules and TQB2450 Injection as a postoperative adjuvant therapy for patients with esophageal squamous cell carcinoma (ESCC). This Phase II, open-label, single-arm study aims to assess the efficacy and safety of this combination treatment, focusing primarily on disease-free survival (DFS). The study also looks at one- and three-year DFS and overall survival rates, along with safety outcomes classified by adverse event severity. Participants will receive treatment in 21-day cycles, taking Anlotinib orally at 12 mg daily for the first 14 days, along with a single intravenous dose of 1200 mg TQB2450 on day one of each cycle. If participants experience side effects from Anlotinib, the dose may be reduced to 10 mg or 8 mg. The study treatment continues as determined by the researchers. During the study, participants will be closely monitored through laboratory tests and imaging to detect any cancer recurrence or progression. Researchers will track disease-free survival from the start of treatment up to 96 months, along with overall survival rates at one and three years. Safety will be evaluated by recording and categorizing adverse events. Participants are expected to follow up regularly and comply with study procedures throughout the treatment and observation period.

Researchers are evaluating the need for antibiotic prevention in patients with chronic liver disease who have gastric varices and are treated with elective endoscopic injection of cyanoacrylate (GVO). Gastric varices can cause serious bleeding with a high chance of rebleeding and mortality. While endoscopic injection of tissue glue is effective in stopping acute bleeding, it still carries risks of rebleeding and infection, which are important concerns for patients with weakened immune systems due to liver conditions. The study compares two groups: one receiving an antibiotic called ertapenem injected intravenously before the endoscopic cyanoacrylate injection, and the other not receiving this antibiotic before the procedure. The trial is randomized and aims to clarify whether giving this antibiotic can help prevent infections and complications after GVO treatment. The treatment is delivered during an elective endoscopic procedure to manage gastric varices. Participants will be monitored for three years to evaluate key outcomes such as the prevention of sepsis, rebleeding rates, refractory bacterial infections, and mortality. Assessments will include tracking infections and bleeding events over time. The study is designed to provide long-term data on the benefits and risks of using antibiotic prophylaxis in this patient group, with ongoing safety monitoring throughout the follow-up period.

Researchers are evaluating the safety and effectiveness of apixaban combined with carvedilol compared to carvedilol alone in preventing complications related to portal hypertension in patients with cirrhosis. This is a prospective, randomized, single-blind, placebo-controlled study conducted at the Asian Institute of Medical Sciences Hospital in Hyderabad, Pakistan. The goal is to provide local evidence for using apixaban in managing cirrhosis and its complications, such as variceal bleeding and portal vein thrombosis. Participants are randomly assigned to one of two groups: one receives apixaban 2.5 mg twice daily plus carvedilol, while the other receives a placebo plus carvedilol. Carvedilol doses start at 6.25 mg once daily and are gradually increased every 2 to 4 weeks to a target of 12.5 mg twice daily, based on heart rate and blood pressure. Those with high-risk varices undergo endoscopic band ligation before randomization for safety. The treatment and follow-up last for 12 months. During the study, participants have visits at baseline, 2 weeks, and at 1, 3, 6, 9, and 12 months. Assessments include vital signs, blood tests, abdominal ultrasound with Doppler, and transient elastography. Adherence is tracked through pill counts and diaries. Researchers will monitor the first occurrence of portal hypertension complications, bleeding events, hospitalizations, and mortality. Safety is carefully reviewed by an independent board throughout the trial.

Researchers are conducting a prospective, multicenter registry to better understand primary biliary cholangitis (PBC), including how it progresses over time, the role of disease-related biomarkers, complications, and symptom burden. Patients with PBC treated at participating centers in Austria will be invited to join the registry, which is managed by the Medical University of Vienna. The registry aims to collect detailed epidemiologic, clinical, and laboratory data to characterize patients across different stages of this liver disease. Participants will be followed through regular clinic visits, generally every 3 to 6 months, with data collected both retrospectively and prospectively. No study-specific treatments or interventions are administered; patients continue their usual care under current treatment guidelines. Optional participation includes contributing biological samples such as blood and liver tissue to a biobank for future research. Data and samples are pseudonymized to protect patient identity. During the study, clinical and laboratory data will be recorded, including assessments of liver disease complications, liver and spleen stiffness, and portal hypertension severity based on imaging and pressure measurements when available. Researchers will track transplant-free survival over an average of 5 years. Patients may withdraw from the registry or biobank at any time. Data security measures ensure restricted access and encrypted data transfer throughout the study period, which extends until December 2040.