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Trial registered on ANZCTR


Registration number
ACTRN12617000448347
Ethics application status
Approved
Date submitted
18/02/2017
Date registered
27/03/2017
Date last updated
5/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The value of liver elastography measurements using endoscopic ultrasonograpy in patients with chronic viral hepatitis B, C and nonalcoholic steatohepatitis.
Scientific title
The value of measuring the liver stiffness using endoscopic ultrasonograpy in patients with chronic viral hepatitis B, C and nonalcoholic fatty liver disease.
Secondary ID [1] 291154 0
Nil konown
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic viral hepatitis B 302010 0
Chronic viral hepatitis C 302011 0
Nonalcoholic steatohepatitis 302012 0
Condition category
Condition code
Infection 301654 301654 0 0
Other infectious diseases
Oral and Gastrointestinal 301853 301853 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 301854 301854 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
1
Target follow-up type
Years
Description of intervention(s) / exposure
Endoscopic ultrasound (EUS)-The patients refered to EUS examination for regular etiologies such as pancreatic cysts, subepithelial lesions, investigation of common bile duct Stones etc will be examined for hepatic parenchymal stiffness using the software for elastography measurement that is already available with the device. This procedure will add only 2-3 minutes to the EUS examination. A seperate and dedicated EUS session will not be planned for the whole patient groups. Those having accompanying Chronic hepatitis B or C or nonalcoholic hepatitis will be evaluated as the study group.
Intervention code [1] 297154 0
Not applicable
Comparator / control treatment
Patients who are evaluated by endoscopic ultrasound for other causes such as subepithelial lesions, pancreatic cysts, etiology of chronic pancreatitis will also be evaluated for the hepatic elastography during the same session.
Control group
Active

Outcomes
Primary outcome [1] 301054 0
Relationship between age of patient and the liver elastography results. Age will be assessed by the birth certificate records and the liver elastography will be measured by endoscopic ultrasound using a special software.
Timepoint [1] 301054 0
At completion of Endoscopic ultrasound
Primary outcome [2] 301278 0
Relationship between obesity and the liver elastography results. Obesity will be assessed by the height, weight and waist circumference measures obtained by the attending physician and the liver elastography will be measured by endoscopic ultrasound using a special software.
Timepoint [2] 301278 0
at completion of Endoscopic ultrasound
Primary outcome [3] 301279 0
Relationship between history of diabetes and the liver elastography results. History of diabetes will be assessed by the self report of the patient and the liver elastography will be measured by endoscopic ultrasound using a special software.
Timepoint [3] 301279 0
at completion of Endoscopic ultrasound
Secondary outcome [1] 331600 0
Relationship between the liver elastography measures obtained by endoscopic ultrasound (EUS) and the histologic liver fibrosis amount in chronic hepatitis patients who have undergone a liver biopsy within the last one year of the EUS procedure. For this outcome, we will not require a liver biopsy but only review the records of the patients.
Timepoint [1] 331600 0
At completion of Endoscopic ultrasound

Eligibility
Key inclusion criteria
All patients who are referred to endoscopic ultrasound examination and who accept the hepatic elastograpgy measurements to be obtained during this examination.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with
-hepatocellular carcinoma
-hepatic metastasis
-liver disease other than chronic viral hepatitis B, C or nonalcoholic steatohepatitis (suc as autoimmune hepatitis,, sclerosing cholangitis, wilson's disease,, pheochromatosis, noncirrhotic portal hypertension.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Liver elastography measures will be numeric values. We will compare those values between study and control groups using student Ttest. For the study group, those patients having a recent liver bipsy will be further analysed using the liver inflammation and fibrosis categories. For this purpose we will usei spearman's correlatiion analysis and chi-square tests.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8655 0
Turkey
State/province [1] 8655 0
Istanbul

Funding & Sponsors
Funding source category [1] 295598 0
Commercial sector/Industry
Name [1] 295598 0
Gilead Pharmaceutical Company
Address [1] 295598 0
Maya Plaza 
Yildirim Oguz Goker Cad
Orkide Sokak No: A3
Kat: 11-12 Akatlar
Besiktas, 34335
Istanbul
Country [1] 295598 0
Turkey
Primary sponsor type
Individual
Name
Deniz DUMAN
Address
Marmara University, School of Medicine, Subdivision of Gastroenterology.
Basibuyuk Mah. Maltepe Basibuyuk Yolu Sok. No:9/1. Maltepe
Country
Turkey
Secondary sponsor category [1] 294430 0
None
Name [1] 294430 0
None
Address [1] 294430 0
Not applicable
Country [1] 294430 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296981 0
Marmara University School of Medicine Clinical Trials Ethics Committee
Ethics committee address [1] 296981 0
Marmara University, School of Medicine, Subdivision of Gastroenterology.
Basibuyuk Mah. Maltepe Basibuyuk Yolu Sok. No:9/1. Maltepe 34854, Istanbul
Ethics committee country [1] 296981 0
Turkey
Date submitted for ethics approval [1] 296981 0
07/11/2016
Approval date [1] 296981 0
02/12/2016
Ethics approval number [1] 296981 0
09.2016.592

Summary
Brief summary
Endoscopic ultrasound (EUS) is a good tool for real-time visualization of the left liver lobe and it has a software to measure the liver elastography which shows the stiffness of the liver. The comparison of EUS-liver elastography and liver biopsy parameters of inflammation and fibrosis is not known. Although EUS is an invasive endoscopic procedure, it has unique beneficial role for the evaluation of subepithelial masses of gastrointestinal tractus such as esophageal varices, common bile duct anomalies such as stones, pancreatic cysts, mediastinal masses....etc. During EUS examination for any indication, the operator can easyly evaluate the liver and can add the liver stiffness findings to the report. This study aims to prospectively evaluate the value of EUS-liver elastographic measurements in patients with chronic hepatitis B, C and nonalcoholic fatty liver disease who were referred to EUS for other indications. The patients who have biopsies in the last 2 years of the EUS-examination will be compared by their EUS- elastography findings and biopsy findings. There will be a control group who have no known positivity for viral hepatitis serology and no liver disease.
Trial website
No website.
Trial related presentations / publications
None
Public notes
None

Contacts
Principal investigator
Name 36582 0
Prof Deniz Duman
Address 36582 0
Marmara University, School of Medicine, Subdivision of Gastroenterology.
Basibuyuk Mah. Maltepe Basibuyuk Yolu, No:9/1 Maltepe, 34854 Istanbul
Country 36582 0
Turkey
Phone 36582 0
+902166254684
Fax 36582 0
Email 36582 0
gduman@marmara.edu.tr
Contact person for public queries
Name 36583 0
Prof Deniz Duman
Address 36583 0
Marmara University, School of Medicine, Subdivision of Gastroenterology.
Basibuyuk Mah. Maltepe Basibuyuk Yolu, No:9/1 Maltepe, 34854 Istanbul
Country 36583 0
Turkey
Phone 36583 0
+902166254684
Fax 36583 0
Email 36583 0
gduman@marmara.edu.tr
Contact person for scientific queries
Name 36584 0
Prof Deniz Duman
Address 36584 0
Marmara University, School of Medicine, Subdivision of Gastroenterology.
Basibuyuk Mah. Maltepe Basibuyuk Yolu, No:9/1 Maltepe, 34854 Istanbul
Country 36584 0
Turkey
Phone 36584 0
+902166254684
Fax 36584 0
Email 36584 0
gduman@marmara.edu.tr

No information has been provided regarding IPD availability
Summary results
No Results