Hepatic Fibrosis Non-invasive Methods Questionnaire

Cirrhosis Clinical Trial

Official title:

Acceptability, Reliability and Applicability of Liver Biopsy and Noninvasive Methods for Assessment of Hepatic Fibrosis and Cirrhosis Among Hepatologists; a Web Based Survey

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02132351
• Other study ID #: MB-1
• Secondary ID: AlazharU-MB-1
• Status: Completed
• Phase: N/A
• First received: May 5, 2014
• Last updated: April 7, 2016
• Start date: August 2013
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Due to the limitations and the invasive nature of liver biopsy, there has been extensive interest in developing non-invasive tests to measure liver fibrosis (1). These are alternatives to liver biopsy that can be used in clinical practice, with benefits in terms of cost, risk, and patient convenience (2). Clinically applicable non-invasive tests include radiological studies, transient elastography (TE), and serum markers. We aim at studying acceptability, reliability, applicability and practical aspects of invasive and noninvasive methods for assessment of hepatic fibrosis and cirrhosis among hepatologists.

Description:

Due to the limitations and the invasive nature of liver biopsy, there has been extensive interest in developing non-invasive tests to measure liver fibrosis (1). These are alternatives to liver biopsy that can be used in clinical practice, with benefits in terms of cost, risk, and patient convenience (2). Clinically applicable non-invasive tests include radiological studies, transient elastography (TE), and serum markers. We aim at studying acceptability, reliability, applicability and practical aspects of invasive and noninvasive methods for assessment of hepatic fibrosis and cirrhosis among hepatologists.

Methods:

The study is a survey study among hepatologists. Four thousand hepatologists will be invited to participate in the questionnaire through e-mail invitations to answer 50 questions of the questionnaire. The questionnaire will be hosted on Survey monkey website and results will be analyzed to get the consensus opinion of participants for the use of invasive and non-invasive methods for assessment of hepatic fibrosis and cirrhosis and factors affecting their preferences.

Statistical analysis plan Analysis of data will be performed using Statistical Package for Scientific Studies 17 for Windows. Description of qualitative variables will be in the form of numbers (No.) and percent (%). Description of quantitative variables will be in the form of mean, standard deviation (SD). Questionnaire results will be compared against different baseline characteristics of the studied group. According to the type and distribution of data, suitable tests for inferential statistics will be used. Significance of the results will be presented in the form of P-value.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 717
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• hepatologists

Exclusion Criteria:

• Non hepatologists

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Liver Cirrhosis

Locations

Country	Name	City	State
Egypt	Al-Azhar Uinversity	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatic fibrosis	Percentage of hepatologists accepting invasive versus non-invasive methods for assessment of hepatic fibrosis and cirrhosis.	3 years	No
Secondary	Trust in non-invasive methods	Percentage of hepatologists trusting invasive versus non-invasive methods for assessment of hepatic fibrosis and cirrhosis.	3 years	No
Secondary	use of non-invasive methods	Percentage of hepatologists who use invasive versus non-invasive methods for assessment of hepatic fibrosis and cirrhosis.	3 years	No
Secondary	combining non-invasive methods	Percentage of hepatologists combining different non-invasive methods for assessment of hepatic fibrosis and cirrhosis.	3 years	No

External Links

•   Survey link