Digestive System Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Liver Cirrhosis

Liver Diseases

Fatty Liver

Fibrosis

Liver Neoplasms

Gastrointestinal Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Visceral Steatosis

Hematinics

All Drugs and Chemicals

Liver Extracts

MRE - Pneumatic driver will be placed over the upper abdomen. Patient will feel a vibration (like a cell phone or beeper vibrating). This vibration will create very small waves in the body. The scanner will then receive the vibrations from the liver and use them to create images of the liver tissue. 2PD MRI - Imaging performed after the MRE procedure and lasting 20-60 seconds. This procedure is useful in identifying fat tissue.

Pneumatic driver will be placed over the upper abdomen. Patient will feel a vibration (like a cell phone or beeper vibrating). This vibration will create very small waves in the body. The scanner will then receive the vibrations from the liver and use them to create images of the liver tissue.

Magnetic Resonance Elastogram

Imaging performed after the MRE procedure and lasting 20-60 seconds. This procedure is useful in identifying fat tissue.

2-Point Dixon Magnetic Resonance Imaging

Haesun Choi, MD

The goal of this clinical research study is to test the accuracy of magnetic resonance elastogram (MRE) and 2-point dixon magnetic resonance imaging (2PD MRI) using new computer software (called "phase correction algorithm") in patients who might have liver disease.

Finding liver damage as early as possible is important. Traditionally, biopsies have been used for this purpose. Biopsies are accurate but can only check a small part of the liver. Tissue fat and liver stiffness are common in patients with liver disease.This study is testing new MRI techniques (called an MRE) that may be able to test for these symptoms on the entire liver, in a short time.

A typical MRI uses a large magnet instead of x-rays to take pictures of the inside of your body. The MRE will be done on a standard MRI scanner.

Study Visit:

The MRE procedure is useful for identifying tissue stiffness. For the MRE procedure, you will lie on your back on the examination table, and a pneumatic driver (a light-weight, clear plastic drum, about 10 inches wide and 1 inch thick) will be placed over the upper abdomen. You will feel a vibration (like a cell phone or beeper vibrating). This vibration will create very small waves in the body. The scanner will then receive the vibrations from the liver and use them to create images of the liver tissue. The MRE will take about 40 seconds. The driver will only be turned on during this time.

Once the MRE is completed, you will then have a 2PD MRI scan while you are still lying on the table. This procedure is useful in identifying fat tissue. This will take about 20-60 seconds. The total exam time will be no more than 20 minutes, including the preparation time.

Once the MRI is completed, you will have a liver biopsy as part of your standard care. You will sign a separate consent form for this procedure.

After the biopsy is performed, your participation in the study will be complete.

This is an investigational study. The scanners and software for 2PD MRI used for this study are FDA-approved and being used in clinical practice. The MRE technique used for this study has not been FDA-approved. At this time, the MRE technique is being used in research only. The use of study data for the purpose of this study is investigational. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.

Magnetic Resonance Elastography and 2-Point Dixon MR Imaging Techniques in Diffuse Liver Disease

Validation Study of Magnetic Resonance Elastography and 2-Point Dixon MR Imaging Techniques in Diffuse Liver Disease

Development of a non-invasive means to quantify hepatic steatosis using 2-Point Dixon technique for patients with \>30% steatosis compared to participants with \<30% steatosis. The degree of steatosis was quantified by percent fat fraction (%FF).

M.D. Anderson Cancer Center

MRE - Pneumatic driver will be placed over the upper abdomen. Patient will feel a vibration (like a cell phone or beeper vibrating). This vibration will create very small waves in the body. The scanner will then receive the vibrations from the liver and use them to create images of the liver tissue. 2PD MRI - Imaging performed after the MRE procedure and lasting 20-60 seconds. This procedure is useful in identifying fat tissue.

Magnetic Resonance Elastogram: Pneumatic driver will be placed over the upper abdomen. Patient will feel a vibration (like a cell phone or beeper vibrating). This vibration will create very small waves in the body. The scanner will then receive the vibrations from the liver and use them to create images of the liver tissue.

2-Point Dixon Magnetic Resonance Imaging: Imaging performed after the MRE procedure and lasting 20-60 seconds. This procedure is useful in identifying fat tissue.

MRE + 2PD MRI

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

Haesun Choi, MD/Professor, Abdominal Imaging Department

MRE Data processing not conducted, therefore data could not be generated.

Overall Image Quality of Magnetic Resonance Elastography (MRE)

Association between degrees of stiffness measured by MRE in kPa and histopathological grades of fibrosis and steatohepatitis processing not conducted, therefore data could not generated.

Association Between Degrees of Stiffness Measured by MRE in kPa and Histopathological Grades of Fibrosis and Steatohepatitis

>30% Steatosis

<30% Steatosis

Participants analyzed are those with liver tumors requiring hepatic resection.

Hepatic Steatosis

Overall Study

Infections

Carcinoma

Carcinoma, Hepatocellular

Endotoxemia

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Other Dietary Supplements

Acidophilus

Bifidobacterium

Placebo: Composition: Each capsule contains 560 mg:

* 459 mg of corn starch
* 6 mg of magnesium stearate

Dosage: 2 capsules / day, in the morning at sunrise, one at bedtime.

Methods of administration: Oral.

Duration of treatment: 14 days

Active substance mixture of lactic 10% Bifidobacterium lactis LA 303, 10% Lactobacillus acidophilus LA 201, LA 40% Lactobacillus plantarum 301, 20% Lactobacillus salivarius LA 302, LA 20% Bifidobacterium lactis 304 Dosage: 10 X 10\^9 probiotic / capsule

Composition: One capsule of 560 mg contains Lactibiane tolerance:

* 345 mg of corn starch
* 114 mg premix lactic
* 6 mg of magnesium stearate Excipients: magnesium stearate

Method of administration: Oral

Dosage: 2 capsules per day for 14 days in two doses: one capsule at sunrise, one capsule at bedtime;

Probiotic

Placebo

Lilian Schwarz, MD

Emmanuel Huet, MD

Surgical resection is one of the curative treatment modalities for HCC. Limits are postoperative septic and liver functional complications related to an increase in bacterial translocation and systemic endotoxemia. Bacterial translocation is a passage of bacteria and bacterial degradation products from the intestine to the portal circulation. The endotoxemia secondary to bacterial translocation, stimulates endothelial production of nitric oxide (NO). NO is also a potent inducer of membrane instability, responsible for an increase in the permeability of the vascular endothelium and intestinal mucosa, possibly contributing to a worsening of bacterial translocation.

Probiotics are live microorganisms which when administered in adequate amounts, provide a health benefit on the host ((Health and Nutritional Properties of Probiotics in Food Including Powder Milk with Live Lactic Acid Bacteria - Cordoba Argentina October 2001). Data from experimental and clinical literature show a significant effect of probiotics on the improvement of liver function and a decrease in infectious complications in patients with chronic liver disease. The proposed study would evaluate the effect preventive and therapeutic in a population of surgical patients, in whom the intestinal portal and hepatic inflammation promotes postoperative complications.

The aim of this study is to evaluate the effect of the administration of probiotics on intestinal barrier function in patients with chronic liver disease (fibrosis stage F3 or F4) operated for hepatocellular carcinoma.

After hepatectomy, kinetic of endotoxemia have been studied previously and the evolution will be summarized by the area under the plasma concentration versus time curve (AUC) of circulating endotoxin levels measured before surgery and at 5 different times analysis after hepatectomy. At 12 hours, portal hypertension and its consequences on gut permeability (impaired barrier function, bacterial translocation) are highest with peak of circulating endotoxins. The decreasing of endotoxemia curve is observed between the 2nd and 3rd day (end of liver regeneration and early liver architectural reorganization). On the 5th day, persist measurable but not deleterious to liver restructured and theoretically functional rates.

Then the main criterion to demonstrate the effectiveness of a diet enriched with probiotics is the AUC of circulating levels of endotoxins ((pg/ml) using the Limulus amebocyte lysate (LAL) assay) observed for each patient. Endotoxin levels were analysed on samples of peripheral blood. The two arms of equal size will be considered significantly different when compared to the AUC of circulating levels of endotoxin if the null hypothesis (AUC is the same for both arms) is rejected in favor of the alternative hypothesis (AUC differs between the two arms - Wilcoxon test)

In order to estimate the sample size to distinguish between the two hypotheses with sufficient power, the median AUC in arm without probiotics be used to form two groups of patients in each arm. Thus, half of the patients without probiotics have a higher median AUC arms. Then, this proportion may be compared to the proportion of patients with probiotics have an AUC greater than the median of the group without probiotics.

The secondary endpoints are:

* Evaluation of systemic inflammation by assay of inflammatory cytokines
* IL-2, IL-4, IL-6, IL-8, IL-10, GM-CSF, IFNa, TNFa
* CRP
* Leukocyte count
* The post-operative liver function monitored in the usual manner
* Standard Liver function tests between J1 and J5 (Bilirubin, prothrombin, ammonia)
* Indocyanine green clearance with measuring retention rates at 15 minutes between J1 and J3
* Monitoring of overall postoperative complications and specifically liver failure and infectious complications at 3 months.

Influence of Probiotics Administration Before Liver Resection in Liver Disease

Circulating Endotoxemia After Liver Resection for Hepatocellular Carcinoma in Liver Disease - Influence of Preoperative Administration of Probiotics

University Hospital, Rouen

Neoplasm Metastasis

Pharmaceutical Solutions

Amino Acids

Arginine

Perioperative Oral Nutritional Supplementation

Placebo of Perioperative Oral Nutritional Supplementation

Oral nutritional supplement containing L-arginin, ω3 polyunsaturated fatty acids, and nucleotides. Given three times a day for the 7 last preoperative and the first 3 postoperative days.

Oral Impact®

Oral solution of placebo. Given three times a day for the 7 last preoperative and the first 3 postoperative days.

Yannick Mallédant, MD

Eric Bellissant, MD, PhD

Philippe Seguin, MD

Karim Boudjema, MD, PhD

Cirrhotic patients undergoing hepatic resection have a mortality rate near 10%, and 30 to 70% of them develop severe complications. These failures are mainly due to hepatic insufficiency. Studies have already shown benefits of oral nutritional supplements in ORL, digestive, and cardiac surgery. We aimed to ascertain whether this nutritional, immune-enhancing supplementation, administered 7 days before and 3 days after surgery, could improve liver function and postoperative host defences in patients with liver cancer resection.

In patients undergoing hepatic resection for liver cancer (with cirrhosis or fibrosis liver), mortality rate can reach 10% and morbidity (ascites, icteria, infections) 70%. These complications are mainly due to hepatic insufficiency: surgery leaves a reduced parenchyma, with oxidative stress lesions due to reperfusion injury. A good preoperative nutritional state has been shown to reduce complications and mortality. This can be amplified by preoperative nutrition with supplements containing L-arginin, ω3 polyunsaturated fatty acids, and nucleotides which boost immune responses, resistance to infections and liver function recovery. In this context, the study randomly assigns 50 patients who were scheduled to undergo hepatic resection, to receive either an oral immune-enhancing nutritional supplement or a placebo, for the 7 last preoperative and the first 3 postoperative days. The aim of the study is to evaluate the effects of this supplementation on liver function, immunity, and incidence of infections after surgery.

Effect of a Perioperative Oral Nutritional Supplementation on Patients Undergoing Hepatic Surgery for Liver Cancer

Prospective, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Effect of Oral Immune-Enhancing Nutritional Supplement on Hepatic Function After Liver Resection for Primary or Secondary Cancer on Cirrhosis or Liver Fibrosis

Ministry of Health, France

Novartis

Rennes University Hospital

Direction of Clinical Research and Strategy

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Syndrome

Sclerosis

Lennox Gastaut Syndrome

Tuberous Sclerosis

Epilepsy

Epilepsies, Myoclonic

Hamartoma

Neoplasms, Multiple Primary

Neoplastic Syndromes, Hereditary

Congenital Abnormalities

Malformations of Cortical Development

Nervous System Malformations

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Epilepsy, Generalized

Brain Diseases

Central Nervous System Diseases

Epileptic Syndromes

Chronic Graft Versus Host Disease

Dravet Syndrome

CDKL5 Deficiency Disorder

Lennox-Gastaut Syndrome

Tuberous Sclerosis Complex

Anticonvulsants

Cannabidiol

Cannabidiol solution 100 milligrams per milliliter (mg/mL) will be administered orally at a dose level of 5 mg/kg/day for 1 week, then increase to 10 mg/kg/day by the participant or their caregiver twice each day (morning and evening).

This study will monitor for potential chronic liver injury and liver fibrosis, in participants treated with cannabidiol oral solution.

Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution

A Long-term Safety Study to Assess the Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution

Jazz Pharmaceuticals

Inflammation

Hepatitis

Hepatic Insufficiency

Liver Failure

Liver Failure, Acute

Hepatitis A

Acute Graft Versus Host Disease

Patient Registry aiming to provide regional evidence documenting the clinical merit of EUS (Endoscopic_ Ultrasound) guided liver biopsy, per local standard of practice, in patients with suspected liver disease indicated for an endoscopic intervention and a liver biopsy.

The finding of this patient Registry may lead to recommendations towards optimizing liver biopsy procedures. If the study demonstrates the optimization of the number of interventions needed to reach diagnostic and therapeutic goals in the setting of suspected liver disease thanks to the utilization of Acquire compared to other liver biopsy procedures, this data can be used as part of economic messaging of the BSC Acquire Fine Needle Biopsy.

This Registry will document all relevant diagnostic and therapeutic radiologic - trans jugular or percutaneous - and endoscopic/endosonographic interventions which enrolled patients undergo when they are suspected to have liver disease and are indicated for an endoscopic procedure and liver biopsy. The study will help illustrate that an EUS guided approach for liver biopsy in patients with suspected liver disease that is indicated for:

Upper endoscopy and Liver biopsy will benefit both the patients and the hospitals from completing both procedures in one setting.

Where possible, the proposed Registry will also allow for the dynamic assessment of the severity of liver disease and for monitoring of changes to therapy for liver fibrosis and/ or portal hypertension. It is anticipated that the ability to monitor changes in liver status over time will become increasingly important as new therapies emerge in the field.

Endoscopic Ultrasound Guided Liver Biopsy and Portal Pressure Registry

Registry of Endoscopic Ultrasound Guided Assessment of the Liver (REGAL Study)

Number of endoscopic, endosonographic, and radiologic interventions undergone to reach a diagnostic liver biopsy in the setting of suspected liver disease from three months prior, to 30 days after the first upper Endoscopy procedure on study \[ Phase 1\]

Number of endoscopic, endosonographic, and radiologic interventions undergone to reach a diagnostic liver biopsy in the setting of suspected liver disease from three months prior, to 12 months after the first upper Endoscopy procedure on study \[ Phase 2\]

Number of serious adverse events related to all livery biopsy study procedures (Phase 1 and Phase 2)

number of participants with abnormal levels of liver function tests

number of participants with abnormal non-invasive liver imaging

Number of diagnostic liver biopsies in radiologically guided compared to the EUS-guided liver.

biopsy (Phase 1 and Phase 2)

Boston Scientific Corporation

Sheikh Shakhbout Medical City

Heart and Blood Diseases

Hypertension

Hypertension, Portal

Hepatitis C

Hepatitis B

Hepatitis B, Chronic

Hepatitis, Chronic

Virus Diseases

Hepatitis C, Chronic

Hepatitis, Viral, Human

Communicable Diseases

Enterovirus Infections

Picornaviridae Infections

RNA Virus Infections

Blood-Borne Infections

Flaviviridae Infections

Hepadnaviridae Infections

DNA Virus Infections

Chronic Disease

Disease Attributes

Herpes Simiae (B Virus)

Norihisa Yada, M.D.

Kazuomi Ueshima, M.D.

Masatoshi Kudo, Professor

This is a multi-center cohort study in which the Real-time Tissue Elastography® measurements will predict prospectively the incidence of hepatocellular carcinoma, the incidence and severity of gastroesophageal varices ascites and decompensated cirrhosis in hepatitis B or C patients.

The aim of this study is to validate the predictive value of Real-time Tissue Elastography® by comparison with serum marker or FibroScan® in chronic hepatitis B or C patients.

Every year and for three years, we performed Real-time Tissue Elastography®, blood sampling, gastrointestinal endoscopy. If in the hospital they can perform FibroScan®, FobroScan® also be performed.

Subjects were also performed ultrasonography (US), computed sonography (CT) or magnetic resonance imaging (MRI) evry four or six months.

The time between the Real-time Tissue Elastography®, blood sampling, gastrointestinal endoscopy and FiroScan® must not exceed four weeks.

Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastography

Prediction of Incidence of Liver Cancer or PorTal Hypertension in Patients With Viral Hepatitis by Use of Real-time Tissue Elastography

Cumulative incidence of carcinogenesis of hepatocellular carcinoma defined as the time from registration to diagnosis of hepatoceluler carcinomais

Cancer-free survival is defined as the time from registration to death due to cencer or any cause

Overall survival is defined as the time from registration to death due to any cause

It is estimated by gastrointestinal scope for every year

Jaundice, ascites, edema and hepatic encephalopathy etc. is evaluated as decompensated cirrhosis.

Kindai University

Japan Liver Oncology Group Organization:

The assignment will be as follows:

(Each DCB-BO1202 300mg capsule contains 150mg active ingredient)

DCB-BO1202: 4 DCB-BO1202 300mg capsules, t.i.d., orally.

Duration of Administration: 96 weeks ((11 treatment weeks + 1 observation week) \* 8 cycles)

DCB-BO1202

The assignment will be as follows:

Placebo: 4 matched placebo, t.i.d., orally.

Duration of Administration: 96 weeks ((11 treatment weeks + 1 observation week) \* 8 cycles)

The assignment will be as follows:

(Each DCB-BO1202 300mg capsule contains 150mg active ingredient)

DCB-BO1202+Placebo: 2 DCB-BO1202 300mg capsules plus 2 matched placebo, t.i.d., orally.

Duration of Administration: 96 weeks ((11 treatment weeks + 1 observation week) \* 8 cycles)

DCB-BO1202+Placebo

Kai-Wen Huang, MD

The purpose of this study is to determine whether an investigational drug DCB-BO1202 is effective and safe in the treatment of liver fibrosis in HBV patients having experienced intermediate stage hepatocellular carcinoma (HCC)

The study will include the first 188 subjects who are randomized. The purpose of study is to collect efficacy results to evaluate treatment effect on the primary endpoint. The second endpoints is to evaluate drug safety on the incidence of the primary endpoint through the treatment period.

A Study to Evaluate a Study Drug, DCB-BO1202, for Alleviating Liver Fibrosis in Liver Cancer Patients

A Phase II Randomized, Double-Blind, Placebo Controlled, Parallel Study of DCB-BO1202 for Alleviating Liver Fibrosis in HBV Patients With Intermediate Hepatocellular Carcinoma Receiving Loco-regional Therapies

GoldenMed BioTechnology

A2 Healthcare Taiwan Corporation

Non-alcoholic Fatty Liver Disease

Natalie Torok, MD

The aim of this proposal is to investigate a novel imaging method to identify patients with non-alcoholic steatohepatitis (NASH) who are at risk for hepatocellular carcinoma (HCC).

NASH is the most common cause of chronic liver disease, and it is estimated that 40-50% of patients with obesity and T2DM have NASH. NASH can lead to HCC with the risk increasing 2-3 fold in patient with poor glycemic control. Unless caught early, HCC has a poor prognosis with no effective therapies. A unique feature of HCC in NASH is that it often arises at a pre-cirrhotic stage, and the prognosis is often dismal. There are no current surveillance strategies for these pre-cirrhotic patients. Based on our animal models and pilot patient studies, we developed a novel paradigm that linked liver matrix changes to a more aggressive HCC phenotype. Our goal is to develop an imaging-based surveillance tool that will identify early matrix changes that may predispose to HCC.

Novel MRE Technique to Assess a Risk Factor for Liver Cancer

Novel MRE Technique to Assess Tissue Viscoelasticity as a Risk Factor for Liver Cancer

Safety:MRE evaluation of the liver for stiffness is a standard of care test. We do not expect issues as this is a non-invasive technique. Our MR may require a longer session compared to the traditional MRE (40 minutes of scan time for multifrequency MRE, as compared to 25 minutes for conventional MRE). However, all issues, patient symptoms will be recorded.

Technical Feasibility: The MRE algorithm we will use has previously been shown to produce data from a different scanner platform, across all frequencies. Feasibility of multifrequency MRE will be assessed by descriptive summary of technical success and image quality for each of the individual reconstructed MRE datasets (stiffness, elasticity, and viscosity). Mean and standard deviation for the MRE outcome variables viscosity elasticity and stiffness will be presented and tested for the difference in means between the 2 groups by way of ANOVA, and if a difference is found, followed by Tukey's test.

assess correlation to liver injury (AST, ALT) assess correlation to glycemic control HbA1c

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Magnetic Resonance Elastography and 2-Point Dixon MR Imaging Techniques in Diffuse Liver Disease	NCT00543777	Liver Cancer	Magnetic Resona... 2-Point Dixon M...	-	M.D. Anderson Cancer Center
Influence of Probiotics Administration Before Liver Resection in Liver Disease	NCT02021253	Liver Fibrosis Liver Cirrhosis Permeability; I... Hepatocellular ...	Probiotic Placebo	18 Years -	University Hospital, Rouen
Effect of a Perioperative Oral Nutritional Supplementation on Patients Undergoing Hepatic Surgery for Liver Cancer	NCT00151671	Liver Cancer Hepatocellular ... Cirrhosis Liver Fibrosis	Oral Impact® Placebo	18 Years -	Rennes University Hospital
Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution	NCT05044819	Lennox Gastaut ... Dravet Syndrome Tuberous Sclero...	Cannabidiol	1 Year -	Jazz Pharmaceuticals
Endoscopic Ultrasound Guided Liver Biopsy and Portal Pressure Registry	NCT05817994	Liver Diseases Liver Neoplasms Liver Dysfuncti... Liver Failure, ... Liver Fibrosis Liver Inflammat...		-	Sheikh Shakhbout Medical City
Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastography	NCT01360892	Chronic Hepatit... Chronic Hepatit...		20 Years -	Kindai University
Magnetic Resonance Elastography and 2-Point Dixon MR Imaging Techniques in Diffuse Liver Disease	NCT00543777	Liver Cancer	Magnetic Resona... 2-Point Dixon M...	-	M.D. Anderson Cancer Center
A Study to Evaluate a Study Drug, DCB-BO1202, for Alleviating Liver Fibrosis in Liver Cancer Patients	NCT02289300	Liver Fibrosis HEPATITIS B CHR... Hepatocellular ...	DCB-BO1202 Placebo DCB-BO1202+Plac...	20 Years - 65 Years	A2 Healthcare Taiwan Corporation
Novel MRE Technique to Assess a Risk Factor for Liver Cancer	NCT05165446	NASH - Nonalcoh...		18 Years - 99 Years	Stanford University
DIAbetes and NAFLD	NCT06315361	NAFLD Diabetes NASH Fibrosis, Liver Cirrhosis, Live... Liver Cancer		18 Years - 80 Years	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastography	NCT01360892	Chronic Hepatit... Chronic Hepatit...		20 Years -	Kindai University
Novel MRE Technique to Assess a Risk Factor for Liver Cancer	NCT05165446	NASH - Nonalcoh...		18 Years - 99 Years	Stanford University

Spots Global Cancer Trial Database for liver fibrosis