Neoplasms

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Carcinoma

Liver Cirrhosis

Carcinoma, Hepatocellular

Liver Failure

Hepatic Insufficiency

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

All Drugs and Chemicals

Liver Extracts

Preoperative evaluation of liver stiffness through FibroScan

FibroScan (Transient Elastography measurement)

Matteo Cescon, MD, PhD

The purpose of this study is to determine whether liver transient elastography performed before the surgical procedure is able to predict liver failure in patients undergoing hepatectomy for hepatocellular carcinoma.

Transient Elastography in Hepatectomy for Hepatocellular Carcinoma

Value of Transient Elastography in Predicting Postoperative Liver Failure in Patients Undergoing Liver Resection for Hepatocellular Carcinoma.

Definition of the cut-off value in kPa able to predict postoperative liver failure, i.e. the presence of at least one of the following variables: ascites causing a delay in the removal of surgical drainages and/or requiring paracentesis; increase of bilirubin levels \>3 mg/dL; alteration of coagulation factors requiring plasma infusion with an INR above 1.50 (with serum bilirubin levels \<12mg/dL); renal impairment, defined as blood urea nitrogen \>2.00 g/L and/or increase of serum creatinine \>2.00 mg/dL requiring only loop diuretics, dopamine/terlipressin, or dialysis.

IRCCS Azienda Ospedaliero-Universitaria di Bologna

MD, PhD, Assistant Professor of Surgery

Infections

Rare Diseases

Hepatitis A

Hepatitis C

Hepatitis

Fibrosis

Hepatitis B

Hepatitis B, Chronic

Hepatitis, Chronic

Hepatitis C, Chronic

Hepatitis, Viral, Human

Virus Diseases

Communicable Diseases

Enterovirus Infections

Picornaviridae Infections

RNA Virus Infections

Blood-Borne Infections

Flaviviridae Infections

Hepadnaviridae Infections

DNA Virus Infections

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Anti-Infective Agents

Central Nervous System Depressants

Lipid Regulating Agents

Ethanol

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Antiviral Agents

Enzyme Inhibitors

Angiotensin-Converting Enzyme Inhibitors

Group conformed by patients experiencing improvement in the noninvasive markers of fibrosis, Fibrotest/Fibrosure and transient elastography, while enrolled in the study.

Group conformed by patients not showing the predefined improvement in the noninvasive markers of fibrosis, Fibrotest/Fibrosure and transient elastography, while enrolled in the study.

Regression of fibrosis will be defined by assessing yearly evolution of noninvasive markers in patients who received antiviral therapy before start of the study, and by comparing baseline markers before start of antiviral therapy to those on subsequent yearly visits in patients prospective recruited (\>50% of cases).

Regression of fibrosis

Such as: family history of liver cancer; body mass index; alcohol, smoking and recreational drug use status; dietary habits, including use of caffeinated drinks; comorbidities such as type 2 diabetes mellitus; use of medications for other chronic diseases such as statins and angiotensin-converting enzyme inhibitors.

Specific risk factors related to hepatocellular carcinoma

Andres Duarte-Rojo, MD, MSc

Jonathan A Dranoff, MD

This study aims to demonstrate that patients with chronic hepatitis C (CHC) and B (CHB) experiencing regression of liver cirrhosis after effective antiviral therapy have decreased risk for hepatocellular carcinoma (HCC). Primary aim is to determine the incidence of HCC in patients with cirrhosis secondary to CHC and CHB, after treatment is provided, and to identify the magnitude of the decreased risk for HCC in patients experiencing regression of fibrosis. As a secondary aim, environmental risk factors for HCC development will be sought, in order to determine a subset of patients in whom it will be safe to stop surveillance.

Cirrhosis is the final pathway of chronic liver disease, and up to 30% of patients develop hepatocellular carcinoma (HCC) within 5 years of diagnosis of cirrhosis. Worldwide, chronic hepatitis C (CHC) and B (CHB) account for the majority of cases of cirrhosis. Successful antiviral treatment results in regression of fibrosis in the majority of patients. Surveillance programs for early detection of HCC mandate the use of imaging (ultrasound/CT-scan) every 6 months. It has been shown in CHC and CHB that the risk of HCC is greatly reduced after viral disease is eradicated/inactive. However, the impact that regression of fibrosis and other factors could have in abating the incidence of HCC has not been systematically investigated. Currently, all patients with eradicated/inactive viral disease continue to be enrolled in HCC surveillance programs, generating anxiety in patients and very high costs to our healthcare system. Fibrotest (FT) and transient elastography (TE) are noninvasive tools proven to be useful for serial assessment of liver fibrosis.

OBJECTIVES: The proposed hypothesis is that patients with regression of liver fibrosis have decreased risk for HCC. Primary aim is to determine the incidence of HCC in patients with cirrhosis secondary to CHC and CHB, during the 3-7 years after treatment is provided, and to identify the magnitude of the decreased risk for HCC in patients experiencing regression of fibrosis. As a secondary aim, environmental risk factors for HCC development will be sought, in order to determine a subset of patients in whom it will be safe to stop surveillance.

METHODS: Patients 18-70 year-old with cirrhosis will be identified from hepatology clinics in 4 academic centers in North America. FT/TE will be obtained before the start of antivirals and yearly thereafter (prospective arm). A retrolective arm of all patients treated no earlier than Jan/2009 will also be included. In this group, baseline FT/TE will be performed off treatment (CHC) or after initial phase of therapy (CHB), and yearly thereafter. During baseline and yearly visits other factors possibly affecting HCC development will be investigated (family history, comorbidities, BMI, diet, etc.). Patients will be classified as having or having not undergone regression of fibrosis after a 3-year follow up, depending on FT and TE evolution. During follow up, all patients will undergo 6-month imaging as part of their routine HCC surveillance. Based on power calculations, enrollment should stop after 924 patients have been recruited. Kaplan-Meier and Cox regression models will be used to analyze data.

PATIENT OUTCOMES: ROLFH study uses state-of-the-art noninvasive markers of liver fibrosis to test whether reversed fibrosis decreases the risk of HCC. We believe this study will lead to a better understanding of HCC risk factors, improved patient counseling and decision making, optimized screening and allocation of health resources, and decreased healthcare costs.

The Regression of Liver Fibrosis and Risk for Hepatocellular Carcinoma (ROLFH) Study

According to Fibrotest/Fibrosure and transient elastography

According to standard imaging surveillance protocol, and confirmatory CT/MRI/biopsy

Positive family history of liver cancer, BMI, active/previous smoking, active/previous alcohol consumption, caffeine consumption in diet, diabetes mellitus, use of drugs for chronic medical conditions

Composite of regression of fibrosis plus other specific conditions decreasing incidence of hepatocellular carcinoma to \<1.5% / year

University of North Carolina, Chapel Hill

University of Toronto

University of Calgary

University of Arkansas

Antineoplastic Agents

Chlorotrianisene

Fibroscan

Stephen Lam Chan, FHKCP

Nicole Yim, RN

In patients with HCC undergoing therapy 1. We aim to determine the prognostic significance of liver stiffness in patients with HCC 2. We aim to determine the rate and severity of complications of treatment and its association with liver stiffness in patients with HCC

Fibroscan Study in HCC

A Study to Evaluate the Impact of Liver Stiffness on Treatment Outcome of Hepatocellular Carcinoma

Chinese University of Hong Kong

Comprehensive Cancer Trials Unit

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Transient Elastography in Hepatectomy for Hepatocellular Carcinoma	NCT01441453	Surgery Hepatocellular ...	FibroScan (Tran...	-	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Transient Elastography in Hepatectomy for Hepatocellular Carcinoma	NCT01441453	Surgery Hepatocellular ...	FibroScan (Tran...	-	IRCCS Azienda Ospedaliero-Universitaria di Bologna
The Regression of Liver Fibrosis and Risk for Hepatocellular Carcinoma (ROLFH) Study	NCT01831037	Chronic Hepatit... Chronic Hepatit...	Regression of f... Specific risk f...	18 Years - 70 Years	University of Arkansas
Fibroscan Study in HCC	NCT01796145	Confirmed Diagn... Patients Who Ar... Child's A to C ...	Fibroscan	18 Years -	Chinese University of Hong Kong

Spots Global Cancer Trial Database for fibroscan

Every month we try and update this database with for fibroscan cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for fibroscan

Every month we try and update this database with for fibroscan cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for fibroscan cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.