Difference in Patterns of Liver Diseases Related Admissions After the Era of DAAS

Difference in Patterns of Liver Diseases Related Admissions in Sohag University Hospital After the Era of Direct Acting Antiviral Drugs

Liver disease accounts for approximately 2 million deaths per year worldwide, 1 million due to complications of cirrhosis and 1 million due to viral hepatitis and hepatocellular carcinoma Hepatitis is defined as inflammation of the liver that can result from a variety of causes such as heavy alcohol use, autoimmune, drugs, or toxins In the United States, the most common types of viral hepatitis are Hepatitis A, Hepatitis B, and Hepatitis C The other types of viral hepatitis are hepatitis D and E and are less frequently encountered Cirrhosis results from chronic liver disease, and is characterized by advanced fibrosis, scarring, and formation of regenerative nodules leading to architectural distortion.In the past cirrhosis was generally thought to be irreversible but recent studies have shown that treatments aimed at the underlying cause especially in earlier stages of the disease can improve or even reverse fibrosis Since its discovery, hepatitis C virus (HCV) has been a constant burden for global health, with 3 to 4 million new infections each year and an overall number of 130-170 million infected people in the world New direct acting antiviral regimens (DAA) have changed the landscape of treatment of chronic hepatitis C DAA provide important advantages, including higher efficacy, shorter duration of treatment and an optimal safety profile Place of the study in patient admitted to Tropical Medicine and Gastroenterology Department, Sohag University Hospital Type of the study The study will be conducted in two stages The first one is a retrospective collection of the data from patients records during the period from Feburary 2017 to January 2018 and the second stage will include agroup of patients that will be admitted to Tropical Medicine and Gastroenterology Department within 6months after protocol acceptance Study period duration of study will be 6months after protocol acceptance Inclusion criteria:

Patients diagnosed with liver diseases(acute hepatitis, chronic hepatitis, liver cirrhosis, HCC and others) depending on clinical evidence of stigmata of liver disease (e.g. jaundice ,ascites ,palmar erythema , spider navi , etc),laboratory data and ultra sonographic features Methods Complete History Taking Clinical ExaminationLaboratory Investigations Abdominal Ultrasonography

Study Overview

• Status: Not yet recruiting
• Conditions: Patternsof Liver Diseasesadmissions After Era of DAAS
• Intervention / Treatment: Behavioral: liver diseases admissions

Detailed Description

Liver disease accounts for approximately 2 million deaths per year worldwide, 1 million due to complications of cirrhosis and 1 million due to viral hepatitis and hepatocellular carcinoma Hepatitis is defined as inflammation of the liver that can result from a variety of causes such as heavy alcohol use, autoimmune, drugs, or toxins In the United States, the most common types of viral hepatitis are Hepatitis A, Hepatitis B, and Hepatitis C The other types of viral hepatitis are hepatitis D and E and are less frequently encountered Cirrhosis results from chronic liver disease, and is characterized by advanced fibrosis, scarring, and formation of regenerative nodules leading to architectural distortion.In the past cirrhosis was generally thought to be irreversible but recent studies have shown that treatments aimed at the underlying cause especially in earlier stages of the disease can improve or even reverse fibrosis Since its discovery, hepatitis C virus (HCV) has been a constant burden for global health, with 3 to 4 million new infections each year and an overall number of 130-170 million infected people in the world New direct acting antiviral regimens (DAA) have changed the landscape of treatment of chronic hepatitis C DAA provide important advantages, including higher efficacy, shorter duration of treatment and an optimal safety profile Place of the study in patient admitted to Tropical Medicine and Gastroenterology Department, Sohag University Hospital Type of the study The study will be conducted in two stages The first one is a retrospective collection of the data from patients records during the period from Feburary 2017 to January 2018 and the second stage will include agroup of patients that will be admitted to Tropical Medicine and Gastroenterology Department within 6months after protocol acceptance Study period duration of study will be 6months after protocol acceptance Inclusion criteria:

Patients diagnosed with liver diseases(acute hepatitis, chronic hepatitis, liver cirrhosis, HCC and others) depending on clinical evidence of stigmata of liver disease,laboratory data and ultra sonographic features Methods Complete History Taking Clinical ExaminationLaboratory Investigations Abdominal Ultrasonography

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: momena H Ahmed, master; Phone Number: 01060178232; Email: moamenahassn@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This study will include all patients admitted at Tropical Medicine and Gastroenterology Department, Sohag University Hospital diagnosed with liver diseases

Description

Inclusion Criteria:

• Patients diagnosed with liver diseases depending on clinical evidence of stigmata of liver disease laboratory data and ultra sonographic features

Exclusion Criteria:

• Any patient without liver disease

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

patients admitted at Sohag University Hospital diagnosed with liver diseases; The study will be conducted in two stages. The first one is a retrospective collection of the data from patients records during the period from Feburary 2017 to January 2018 and the second stage will include agroup of patients that will be admitted to Tropical Medicine and Gastroenterology Department within 6months after protocol acceptance

Behavioral: liver diseases admissions; The different patterns of liver disease related admissions after the era of DAAS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The different patterns of liver disease in patients admitted to Sohag University Hospital after the era of direct acting antiviral drugs	from 15 March 2022 to 15 September 2022

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Principal Investigator: momena H Ahmed, master, Sohag University; Study Director: Mona M Abdelrahman, MD, Sohag University; Study Chair: Asmaa N Mohammed, MD, Sohag University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 15, 2022
• Primary Completion (Anticipated): September 15, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: March 10, 2022
• First Submitted That Met QC Criteria: March 10, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 10, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: Soh-Med-22-03-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No