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Liver Diseases clinical trials

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NCT ID: NCT05998330 Recruiting - Cirrhosis Clinical Trials

LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease

LiverPAL
Start date: September 20, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate whether early integration of palliative care in the care of hospitalized patients with advanced liver disease (AdvLD) can improve patients' quality of life, physical symptoms, mood, and serious illness communication. Palliative care is a medical specialty focused on lessening (or "palliating") symptoms and assisting in coping with serious illness.

NCT ID: NCT05931068 Recruiting - Cancer Clinical Trials

Perioperative Energy Expenditure in Major Liver Resection

PRO-NRG
Start date: May 1, 2023
Phase:
Study type: Observational

Rationale: Complication rates after major liver resections remain as high as 43%. Many initiatives have been taken to reduce postoperative morbidity. As such, prehabilitation programmes are increasingly used for patients undergoing major abdominal surgery. Improvement of aerobic fitness has been proven to reduce complication rates, especially in high-risk patients (those with a low preoperative aerobic capacity). Different conceptual hypotheses exist of the underlying mechanism of variability in postoperative complications and prehabilitation response. One of the complementary rationales focusses on homeostasis-allostasis before and after surgery, more specifically on the preoperative aerobic capacity to meet postoperative metabolic demands. However, more insight in postoperative metabolic demands (energy expenditure) during in-hospital recovery from major abdominal surgery in relation to preoperative resting metabolic demands and maximal aerobic capacity is essential to understand the increase in metabolic demands coinciding with major surgery in relation to the body's reserve capacity. This information can be used to better understand the rationale behind exercise prehabilitation, as well as to optimize the content of preoperative treatment for unfit patients, for instance by means of personalized prehabilitation programs that might improve postoperative outcomes. Objective: This study aims to explore the difference of pre- and postoperative energy expenditure in patients undergoing major elective liver resection and relate this to their preoperative aerobic capacity. Study design: The study will be a prospective observational study with thorough pre- and postoperative measurements of energy expenditure. Energy expenditure will be measured using the doubly labelled water method, as well as by indirect calorimetry. To assess aerobic capacity, cardiopulmonary exercise testing will be performed pre- and postoperatively. Additionally, accelerometers will be used to evaluate pre- and postoperative physical activity levels. Study population: Patients aged ≥18 years undergoing major liver resection (≥3 segments) will be asked to participate. The inability to perform cardiopulmonary exercise testing, neo-adjuvant chemotherapy, and cirrhotic liver are reasons for exclusion. Main study parameters/endpoints: The main study parameter is the difference of energy expenditure pre- and postoperatively, as measured with doubly labelled water and indirect calorimetry. Secondary endpoints: Additionally, as secondary endpoints, aerobic fitness, physical activity level, and postoperative complications will be assessed.

NCT ID: NCT05912179 Recruiting - Liver Diseases Clinical Trials

Prospective Single Centre Observational Study to Compare the Diagnostic Yield of Different Modalities of Liver Biopsy

Start date: September 1, 2022
Phase:
Study type: Observational

The goal of this study is to learn about endoscopic ultrasound(EUS) guided liver biopsy and how this compares to traditional methods of obtaining liver biopsy samples, in patients with liver disease. The main questions it aims to answer are: 1. is EUS liver biopsy equally as good as other types of techniques 2. are there any advantages to using the EUS technique to obtain liver biopsies Researchers will compare data from patients who have had a liver biopsy with a traditional technique with those who have undergone EUS-guided biopsy.

NCT ID: NCT05900037 Recruiting - Liver Diseases Clinical Trials

GATT-Patch Versus SURGICEL® Original in Minimally Invasive Liver and Gallbladder Surgery

Start date: October 6, 2023
Phase: N/A
Study type: Interventional

This is a pre-market, prospective, randomized (1:1), multicenter, pivotal clinical investigation. The purpose of this investigation is to determine the clinical performance of GATT-Patch as compared with SURGICEL® Original for the management of minimal, mild, or moderate bleeding during minimally invasive liver and gallbladder surgery.

NCT ID: NCT05770284 Recruiting - Liver Diseases Clinical Trials

Effect of Exercise Based Regimen on Frailty in Children With Liver Disease

Start date: March 15, 2023
Phase: N/A
Study type: Interventional

Frailty is now a well-known complication of liver disease and various studies, including pediatric literature studies, have recognized it as a poor prognostic factor in CLD as well as liver transplant settings. It is associated with poor quality of life, increased hospitalisation and mortality. Exercise for >12 weeks leads to improvements in aerobic power (peak VO2), aerobic endurance, muscle mass and strength, health related quality of life (HRQoL)(1). Although effect of Exercise on sarcopenia and frailty has been studied extensively in cirrhotic adults, there is paucity of such literature on the effect of exercise on frailty in children. Through this study, we aim to assess efficacy of exercise-based regimen on frailty in children with chronic liver disease after 12 weeks. Our secondary objective will be to compare outcome between the two groups(frail and non frail children with liver disease) and to compare change in frailty scores between the two groups. Other objectives will include assessment of the body composition analysis and the myokines and hepatokines signatures of children with liver disease (pre and post exercise intervention).

NCT ID: NCT05733832 Recruiting - Liver Diseases Clinical Trials

A Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease

TLC
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

Patients with complications of advanced liver disease often have difficulties after hospital discharge that result in early hospital readmission. Poor outcomes for these patients during this transitional time could be improved through the use of innovative transitional care models. This proposal aims to examine the effect of a transitional care model, The Transitional Liver Clinic (TLC), in reducing hospital re-admissions, improving quality of life, and improving patient experience.

NCT ID: NCT05567328 Recruiting - Liver Diseases Clinical Trials

Validation of the New Vibration-guided FibroScan Examination

Start date: October 26, 2022
Phase: N/A
Study type: Interventional

This is an European, prospective, interventional, multicenter clinical investigation that will take place in 2 French sites. 100 adults patients will be included. The study objective is to compare the applicability between the Research FibroScan and the reference FibroScan examination performed on the liver.

NCT ID: NCT05499585 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Treating Pediatric NAFLD With Nutrition

Start date: September 12, 2022
Phase: N/A
Study type: Interventional

This is a proof of concept clinical trial to compare daily intake of at least 20 grams of whole dairy fat vs habitual diet on hepatic steatosis in children with NAFLD.

NCT ID: NCT05470205 Recruiting - Liver Diseases Clinical Trials

Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension; Renewal

Start date: November 28, 2022
Phase: Phase 3
Study type: Interventional

This is an open-label, non-randomized trial that will be conducted at three clinical sites, Thomas Jefferson University (TJU), the Hospital of the University of Pennsylvania (HUP) and University of Bern (UB). Enrollment will be allocated into one of 4 different cohorts depending on the inclusion criteria for each cohort. Cohort 1: Patients scheduled for hepatic vein pressure gradient (HVPG) measurements will subsequently undergo two consecutive SHAPE (subharmonic aided pressure estimation) procedures using different ultrasound contrast agents (Definity [Lantheus Medical Imaging, N Bilerica, MA, USA] and Sonazoid [GE Healthcare, Oslo, Norway] in randomized order) to estimate portal pressures with a Logiq E10 scanner (GE Healthcare, Waukesha, WI, USA) and determine the reproducibility of the SHAPE algorithm. Cohort 2: Patients identified as having clinically significant portal hypertension (CSPH) will be monitored by SHAPE with Sonazoid for the duration of this project (18-24 months on average). These subjects will have follow-up ultrasound scans every 6 ± 2 months to check for hepatocellular carcinoma (HCC) (using the Barcelona-Liver Cancer staging system) as well as ascites and at those times a repeat SHAPE examination will be performed. Liver stiffness values will be measured with elastography as well. This cohort will examine if serial SHAPE can accurately predict development of ascites and other liver related events in patients with compensated cirrhosis undergoing routine HCC surveillance in a multi-center setting. Cohort 3: Subjects newly diagnosed with portal hypertension and starting treatment with non-selective β-blockers will be monitored with SHAPE and results compared to elastography measurements of liver stiffness with standard assessments (e.g., serum liver function tests and measurement of spleen size as well as platelet count). This cohort will establish if SHAPE can be used to monitor treatment response in patients identified with portal hypertension. Cohort 4: Patients with compensated advanced chronic liver disease scheduled for an endoscopy examination for screening of varices relative to the Baveno VI and the expanded-Baveno VI criteria as well as the AST to Platelet Ratio Index will undergo a SHAPE examination. This cohort will compare the predictive ability of SHAPE for allocating patients with compensated advanced chronic liver disease to screening of varices compared to the current standard of care.

NCT ID: NCT05457543 Recruiting - Healthy Clinical Trials

Blood Collection for Development and Validation of Point-of-Care Diagnostic Liver Function Tests

Start date: June 30, 2022
Phase:
Study type: Observational

This is an observational study exploring the performance of a novel point-of-care diagnostic testing platform designed to quantitate the presence of liver function biomarkers such as bilirubin. Blood samples will be collected from participants to further development and validation of the testing platform to support FDA review. The diagnostic device is intended to provide rapid in-office test results using a finger stick of blood, a reaction test device, and a smartphone app.