Clinical trial NCT02132351: Hepatic Fibrosis Non-invasive Methods Questionnaire
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cirrhosis
Fibrosis
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2014-05-07
Enrollment: 717
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hepatologists

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* hepatologists

Exclusion Criteria:

* Non hepatologists

Primary outcomes:
measure: Hepatic fibrosis
timeFrame: 3 years
Secondary outcomes:
measure: Trust in non-invasive methods
timeFrame: 3 years
measure: use of non-invasive methods
timeFrame: 3 years
measure: combining non-invasive methods
timeFrame: 3 years
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar Uinversity
Study officials:
affiliation: Al-Azhar University
name: Mohamed Alboraie, M.Sc
role: PRINCIPAL_INVESTIGATOR
References: