Hepatic Fibrosis Non-invasive Methods Questionnaire

NCT ID: NCT02132351

Last Updated: 2016-04-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 717 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-04-30

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.

Conditions

Cirrhosis; Fibrosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Hepatologists

Doctors working as hepatologists

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• hepatologists

Exclusion Criteria

• Non hepatologists

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Alboraie

Post graduate researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Alboraie, M.Sc

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University

Locations

Al-Azhar Uinversity

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

AlazharU-MB-1

Identifier Type: OTHER

Identifier Source: secondary_id

MB-1

Identifier Type: -

Identifier Source: org_study_id