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Completed

NCT Number: NCT02132351

Hepatic Fibrosis Non-invasive Methods Questionnaire

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Al-Azhar Uinversity

Cairo, Cairo Governorate, 11884, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • hepatologists

Exclusion criteria

  • Non hepatologists

Treatment and study plan

Primary outcomes

  1. Hepatic fibrosis

    Time frame: 3 years

    Percentage of hepatologists accepting invasive versus non-invasive methods for assessment of hepatic fibrosis and cirrhosis.

Secondary outcomes

  1. Trust in non-invasive methods

    Time frame: 3 years

    Percentage of hepatologists trusting invasive versus non-invasive methods for assessment of hepatic fibrosis and cirrhosis.

  2. use of non-invasive methods

    Time frame: 3 years

    Percentage of hepatologists who use invasive versus non-invasive methods for assessment of hepatic fibrosis and cirrhosis.

  3. combining non-invasive methods

    Time frame: 3 years

    Percentage of hepatologists combining different non-invasive methods for assessment of hepatic fibrosis and cirrhosis.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 7, 2014
Registry last updated
Apr 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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