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100 active trials for Liver Cirrhosis

Surveillance Study for HCC by Combining Biomarkers With Imaging (ALDUS)

This study is intended to be a prospective observational study at multiple sites, not a randomized controlled trial (RCT). The uses of the biomarkers has been approved by government regulations and adopted for surveillance programs in some countries, thus an RCT which compares patients followed by US alone with patients followed by both US and the biomarkers would raise an ethical conflict, especially in countries where the biomarkers have been routinely used. For this study, enrolled patients will be followed by US and the biomarkers at regular intervals and classified after completing the study to evaluate the clinical effectiveness of the biomarkers. The comparisons of sensitivity, specificity, and other parameters with respect to tumor characteristics will be made among US alone, the biomarkers, and combined use of US and the biomarkers. Also economical effectiveness of using the biomarkers will be investigated in this study. Requirement status is monitored every month.

Start: May 2013

Combining Biomarkers (AFP, AFP-L3, and PIVKA-II) and Image Tools for Early Detection of Hepatocellular Carcinoma

In this study, three biomarkers tests (AFP, AFP-L3 and PIVKA-II) and abdominal sonography or CT scans are performed every 6 months to detect hepatocellular carcinoma (HCC) early in patients with cirrhosis, a high-risk group of HCC. The aim of this study is to confirm the early HCC diagnosis rate in patients with cirrhosis and compare the detection efficacy between tests.

Start: July 2016

VICIS - Vienna Cirrhosis Study

Patients with advanced chronic liver diseases treated at the Vienna General Hospital of the Medical University of Vienna will be offered to participate in this prospective observational trial. Clinical parameters and laboratory parameters will be recorded for all patients and patients will undergo a regular follow-up schedule with clinical visits at the Vienna General Hospital. This study is linked to a biobank with serum/plasma, ascitic fluid, urine, GI tract mucosal biopsies, liver biopsies and stool collected from the study participants.

Start: February 2017

Oral Health Status in Patients With Cirrhosis and Effect of Dental Treatment on MELD Score of Cirrhosis Patients

It has been found that there is an association between prevalence of odontogenic infection and systemic diseases.Cirrhosis has also been associated with poor oral health status.Treating those patients accordingly can help in reducing the source of infection to some extent and may be associated with reduction in mortality.

Start: January 2020

Anticoagulation Therapy After Splenectomy in Cirrhosis Patient

1. Inclusion and Exclusion Criteria Inclusion criteria: Inpatients who received laparotomy or laparoscopic splenectomy according to clinical, B-ultrasound scan, CT or MRI diagnosis of cirrhosis and portal hypertension. Exclusion criteria: ) Portal vein system thrombosis (PVST) found by preoperative color Doppler ultrasound or MRI examination; ) Liver cirrhosis complicated with liver tumor; ) Liver cirrhosis complicated with blood system diseases; ) Patients who have not signed the informed consent form. 2. Research subgroup According to the order of the patients, the following groups are entered in turn, and the cycle is repeated. ) Heparin group ) Rivaroxaban group ) Control group.

Start: February 2018

Skeletal Muscle Parameters of Liver Cirrhosis in Non-invasive Imaging and Outcome

The principal aim of this study is to analyse L3-SMI (skeletal muscle index) in a cohort of patients with decompensated liver cirrhosis and TIPS (transjugular intrahepatic portosystemic shunt), and compare the prognostic power with TPMT (transverse psoas muscle thickness). Furthermore, the role of myosteatosis, determined in CT by L3-SMI, MRI and ultrasound will be studied.

Start: January 2018

The Tolerability?Safety?PK/PD Study of rhTPO in the Patients With Liver Function Impairment

The purpose of this study is to evaluate the tolerability, safety, pharmacokinetics and pharmacodynamics of recombinant human thrombopoietin in the patients with different degree of liver function impairment according Child- Pugh class.

Start: June 2018

A Phase II Open-label Single-arm Study to Evaluate the Efficacy and Safety of ADSCs in Subjects With Liver Cirrhosis

The aim of the investigators study was to investigate the safety and efficacy of autologous ADSCs for the clinical treatment of liver cirrhosis.

Start: February 2020

Safety and Efficacy Study of Co-transfering of Mesenchymal Stem Cell and Regulatory T Cells in Treating End-stage Liver Disease

Cirrhosis of the liver is a common clinical chronic progressive liver disease, which is a diffuse liver lesion caused by one or more causes over a long period of time or repeatedly. Nodules, abnormal spherical areas of cells, form as dying liver cells are replaced by regenerating cells. This regeneration of cells causes the liver to become hard. The potential for stem cells to differentiate into hepatocytes cells was recently confirmed. In particular, mesenchymal stem cell (MSC) transplantation has been applicated in the clinic for treat several human diseases such as liver injury and liver fibrosis displayed good tolerance and efficiency. Besides, regulatory T cells(Tregs) had been proved as an immune regualtory T cell subsets, which could reduce immune cell activation and reduce liver injury severity. The purpose of this study is to learn whether and how MSCs and Tregs can improve the disease conditions in patients with decompensated cirrhosis.

Start: June 2020

Changes in Body Composition and Nutritional Status in Patients Undergoing Liver Transplantation

Liver transplant is the goal treatment for every patient with end-stage chronic liver disease. Quality of life improves after transplant because the main complications of end-stage liver disease disappear, but due to immunosuppression other alterations appear such as metabolic alterations, weight gain, among others. Body composition and nutritional status can be affected do to post-transplant pharmacologic therapy.

Start: January 2019

Methods for Nutritional Assessment in Cirrhosis

Nutritional status in patients with cirrhosis has been shown to have a direct influence on the prognosis of these patients, it is related to higher mortality and it has been linked to the developement and perpetuation of certain complications such as hepatic encephalopathy, ascites and spontaneous bacterial peritonitis. Despite the importance of nutritional status in this patients, most of the methods for its assessment are still not completely reliable or not easily accessible; therefore, evaluating nutritional status in the daily clinical practice is still a complex task.

Start: December 2016

Hepatocellular Carcinoma in HIV-infected Patients

Observational study. All HIV-infected patients who have been diagnosed of hepatocellular carcinoma (HCC), following the American Association for the Study of Liver Diseases (AASLD) criteria, in the participant centers are included. Epidemiological, clinical and laboratory data are collected. The clinical and epidemiological characteristics of HCC cases will be analyzed. The efficacy and outcomes after modalities of HCC therapy will be assessed. Mortality and its predictors will be also assessed. In those cases infected by hepatitis C virus (HCV), the impact of HCV therapy on outcomes will be analysed.

Start: May 2014

Embolization of Large Spontaneous Portosystemic Shunts for the Prevention of Post-TIPS Hepatic Encephalopathy

The purpose of this study is to determine whether transjugular intrahepatic portosystemic shunt (TIPS) combined with large spontaneous portosystemic shunts embolization are effective in the prevention of hepatic encephalopathy (HE).

Start: June 2014

TIPS Combined With Variceal Embolization for the Prevention of Variceal Rebleeding in Patients With Cirrhosis

The purpose of this study is to determine whether TIPS combined with variceal embolization are effective in the prevention of variceal rebleeding in patients with liver cirrhosis.

Start: June 2014

TIPS vs. NSBB Plus Endotherapy for the Prevention of Variceal Rebleeding in NSBB Non-responders of Primary Prophylaxis

Variceal bleeding (VB) is a life-threatening complication of cirrhosis with a 6-week mortality of approximately 15%-20%. The 1-year rate of recurrent VB is approximately 60% in patients without prophylaxis treatment. Therefore, all patients who survive VB must receive active treatments to prevent rebleeding. Usually, these patients are submitted to rebleeding prophylaxis with endoscopic band ligation (EBL) combined with non-selective beta-blockers (NSBB). Transjugular intrahepatic portosystemic shunts (TIPS) are reserved for those who failed endoscopic plus medical treatment. A recent meta-analysis comparing combination therapy to monotherapy with EBL or drug therapy has demonstrated that combination therapy is only marginally more effective than NSBB alone. This suggests that NSBB is the cornerstone of combination therapy. The lowest rebleeding rates are observed in patients on secondary prophylaxis who are hepatic venous pressure gradient (HVPG) responders (defined as a reduction in HVPG below 12 mm Hg or > 20% from baseline). A recent study demonstrated that patients who have their first episode of variceal bleeding while on primary prophylaxis with NSBB have an increased risk of further bleeding and death, despite adding EBL. These patients possibly require alternative treatment approaches, such as TIPS. The aim of the present study was to compare the effect of TIPS vs. EBL + NSBB for the prevention of rebleeding in NSBB non-responder for primary prophylaxis.

Start: June 2020

Effect of Portal Vein Thrombosis on the Prognosis of Liver Cirrhosis

The prevalence of portal vein thrombosis (PVT) in patients with liver cirrhosis is 5-20%. Current evidence regarding the effect of portal vein thrombosis on the prognosis of cirrhotic patients remains under debate. Considering that PVT potentially elevates the portal pressure and thereby increase the risk of variceal bleeding, we focus on the patients with high-risk varices and variceal bleeding as the study population. Thus, the main goals are to analyze the effect of PVT on the incidence of first variceal bleeding in patients without any prior bleeding history but with high-risk varices, the incidence of recurrent variceal bleeding in patients with a history of variceal bleeding, and the treatment failure rate of variceal bleeding in patients with acute variceal bleeding. Certainly, the survival is also observed in all patients.

Start: December 2014

Safety and Efficacy of SHED for Decompensated Liver Cirrhosis

This study is an prospective, randomized control study. Patients with decompensated cirrhosis will be randomly assigned to receive 4 times of SHED treatment plus standard medical care(treatment?or standard medical care (control). The primary outcome is MELD-Na score. Secondary outcomes are Child-Pugh, liver function, life quality and survival.

Start: December 2019

Nurse Assisted Post-discharge Intervention in Decompensated Cirrhosis

In a randomized controlled trial, the effects of a nurse-driven post-discharge intervention for patients with liver cirrhosis compared with standard follow-up will be investigated.

Start: November 2019

Hepatic Venous Pressure Gradient-guided Versus Standard Beta-blocker Therapy in Primary Prevention of Variceal Bleeding

Study hypothesis: Hepatic venous pressure gradient (HVPG)-directed primary prophylaxis with nonselective beta-blocker therapy (NSBB) leads to a reduction in first variceal bleeding episodes and is cost-effective in the long term. Study design: A multi-center randomized controlled study comparing nonselective beta-blocker therapy guided by the hemodynamic response as determined by the difference in HVPG before and after starting oral NSBB therapy, to standard heart rate-guided NSBB therapy in patients with esophageal varices due to liver cirrhosis without a history of esophageal variceal hemorrhage. Primary study parameters/outcome of the study: First variceal bleeding episodes occurring within the first two years. Secondary study parameters/outcome of the study: Mortality Occurrence of other cirrhosis-related complications Occurrence of hepatocellular carcinoma Costs of treatments Adverse effects

Start: September 2012

Annual MRI Versus Biannual US for Surveillance of Hepatocellular Carcinoma in Liver Cirrhosis

The investigators will investigate the usefulness of biannual ultrasonography versus annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma in single arm patients.

Start: September 2015