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Trial details
Liver diseases in Lebanon
Current status:
Approved
|
Date registered:
17/07/2020
|
Date last updated:
17/07/2020
Trial version(s)
Current: 15/07/2020
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Main Information
Primary registry identifying number
LBCTR2020074524
Protocol number
BIO-2018-0009
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Retrospective
Type of registration: Justify
LBCTR was not established at time of study
Date of registration in national regulatory agency
15/07/2020
Primary sponsor
PI initiated
Primary sponsor: Country of origin
Lebanon
Public title
Liver diseases in Lebanon
Acronym
Scientific title
Spectrum of Liver diseases in Lebanon: a retrospective cohort study
Acronym
Brief summary of the study: English
Liver diseases is a worldwide etiology causing high morbidity and mortality. Fibroscan is a quick, painless examination performed in clinic or at the patient’s bedside. It is used to evaluate liver status for patients with suspected liver disease prognosis. This study aims at describing the spectrum of liver diseases among patients performing Fibroscan at a tertiary care center in Lebanon. Methods: This is a retrospective data collection study on patients who underwent Fibroscan at the American University of Beirut hepatobiliary unit between 2015 and 2018. Medical charts of all patients were reviewed. Data were collected and analyzed using SPSS 25 software. Results: A total of 620 patients presented to the hepatobiliary unit for Fibroscan, of which 419(67.5%) were males. The mean age was 47.8±13.4 (range 18-84). 362(58.3%) had NAFLD, 89(14.3%) had Hepatitis-B, 69(11.1%) had Hepatitis-C, 48(7.7%) had ALD, 20(3.3%) had DILI, and 13(2.9%) had autoimmune hepatitis. 190(30.6%) were overweight (BMI over 25), 128(20.6%) had diabetes. Liver stiffness corresponding to the diagnosis of F4 liver fibrosis stage on Fibroscan was mostly reported in 6(46.5%) autoimmune hepatitis, 101(27.9%) NAFLD, and 18(26.1%) HCV patients. 141(45.5%) patients who had one or more metabolic risk factors suffered from severe stage steatosis compared with 78(28.9%) who had not any risk factors with P-value 0.04. Conclusions: Based on our sample, NAFLD is emerging as a predominant etiology of CLD, followed by, HBV, and HCV. This is the first study that reports CLD status in Lebanon, further studies that describe the prevalence and incidence of the disease at a larger scale are needed.
Brief summary of the study: Arabic
أمراض الكبد هي مسببات عالمية تسبب المراضة والوفيات العالية. Fibroscan هو فحص سريع وغير مؤلم يتم إجراؤه في العيادة أو بجوار سرير المريض. يتم استخدامه لتقييم حالة الكبد للمرضى الذين يشتبه في تشخيصهم لأمراض الكبد. تهدف هذه الدراسة إلى وصف طيف أمراض الكبد بين المرضى الذين يؤدون الفبروسكان في مركز رعاية جامعية في لبنان. طرق: هذه دراسة جمع البيانات بأثر رجعي عن المرضى الذين خضعوا ليبروسكان في وحدة الكبد في الجامعة الأمريكية في بيروت بين عامي 2015 و 2018. تمت مراجعة المخططات الطبية لجميع المرضى. تم جمع البيانات وتحليلها باستخدام برنامج SPSS 25. النتائج: قدم ما مجموعه 620 مريضا إلى الوحدة الكبدية الصفراوية فيبروسكان ، منهم 419 (67.5 ٪) من الذكور. كان متوسط العمر 47.8 ± 13.4 (نطاق 18-84). 362 (58.3٪) مصاب بـ NAFLD ، 89 (14.3٪) مصاب بالتهاب الكبد- B ، 69 (11.1٪) مصاب بالتهاب الكبد- C ، 48 (7.7٪) مصاب بمرض التصلب العصبي المتعدد ، 20 (3.3٪) مصاب بـ DILI ، و 13 (2.9٪) كان يعاني من التهاب الكبد المناعي الذاتي. 190 (30.6٪) يعانون من زيادة الوزن (مؤشر كتلة الجسم فوق 25) ، 128 (20.6٪) مصابون بالسكري. تم الإبلاغ عن تصلب الكبد المقابل لتشخيص مرحلة تليف الكبد F4 على الليفوسكان في الغالب في 6 (46.5٪) من التهاب الكبد المناعي الذاتي ، 101 (27.9٪) NAFLD ، و 18 (26.1٪) من مرضى HCV. عانى 141 مريضاً (45.5٪) ممن لديهم عامل أو أكثر من عوامل الخطر الأيضية من تنكس حاد في المرحلة مقارنة بـ 78 (28.9٪) لم يكن لديهم أي عوامل خطر ذات قيمة P 0.04. الاستنتاجات: بناءً على نموذجنا ، يظهر NAFLD كمسببات سائدة لـ CLD ، يليه HBV و HCV. هذه هي الدراسة الأولى التي تشير إلى حالة CLD في لبنان ، وهناك حاجة إلى مزيد من الدراسات التي تصف انتشار وانتشار المرض على نطاق أوسع.
Health conditions/problem studied: Specify
liver diseases
Interventions: Specify
none no research intervention was done
Key inclusion and exclusion criteria: Inclusion criteria
all adults who presented for fibroscan at AUBMC hepatobiliary unit between 2016 and 2018
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
99
Key inclusion and exclusion criteria: Exclusion criteria
age less than 18
Type of Study
Type
Observational
Study model
Cohort
Study model: Explain model
liver disease
Time perspective
Retrospective
Time perspective: Explain time perspective
we collected all data from the date of fibroscan machine availability at AUBMC
Target follow-up duration
0
Target follow-up duration: Unit
NA
Number of groups/cohorts
1
Biospecimen retention
None retained
Biospecimen description
NA
Target sample size
470
Actual enrollment target size
Date of first enrollment: Type
Actual
Date of first enrollment: Date
01/01/2016
Date of study closure: Type
Actual
Date of study closure: Date
31/12/2019
Recruitment status
Complete
Date of completion
IPD sharing statement plan
No
IPD sharing statement description
data will be shared upon request
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
NA
NA
Sources of Monetary or Material Support
Name
NA
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Rola
jaafar
beirut
Lebanon
01350000
rj29@aub.edu.lb
AUBMC
Scientific
walid
faraj
beirut
Lebanon
01350000
wf07@aub.edu.lb
AUBMC
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
AUBMC
Walid Faraj
General Surgeon
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
American University of Beirut Medical Center
15/05/2017
Dana Fakhredine
df17@aub.edu.lb
01350000
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
liver disease
Liver disease, unspecified (K76.9)
fibrosis
Interventions
Intervention
Description
Keyword
none
no interventions were made
fibroscan
Primary Outcomes
Name
Time points
Measure
NAFLD percentage
at time of test
number of patients
alcoholic fatty liver
at time of test
number of patients
Hep A, B and C infections
at time of test
number of patients
Key Secondary Outcomes
Name
Time points
Measure
risk factors associated with liver etiology
at time of test
number of patients
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial