VIRal Hepatitis and GAllstone Disease Study (VIRGAD)

Viral Hepatitis and Gallstone Disease Study

The study aims to investigate possible associations between ongoing viral hepatitis (i.e. hepatitis A, B, C or E virus infection) and ultrasound or computed tomography-verified gallstone disease.

Study Overview

• Status: Unknown
• Conditions: Viral Hepatitis; Gallstone Attack

Detailed Description

Patients seeking care at emergency room at Sahlgrenska University Hospital, Gothenburg, Sweden undergoing ultrasound or computed tomography for suspected gallstone disease, will be asked if they wish to participate in the study. If they agree, a serum sample will be draw for analysis of anti-HAV IgM, HBsAg, anti-HCV, HCV Core antigen and HEV RNA. The proportion of patients with vs. without ultrasound or computed tomography-verified gallstone disease will be evaluated regarding possible ongoing viral hepatitis (i.e. hepatitis A, B, C or E virus infection).

• Study Type: Observational
• Enrollment (Anticipated): 350

Contacts and Locations

• Study Contact: Name: Martin Martin, MD PhD; Phone Number: +46-(0)705-68 37 59; Email: martin.lagging@medfak.gu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with and without ultrasound or computed tomography-verified gallstone disease will be compared for biomarkers of ongoing viral hepatitis (i.e. anti-HAV IgM, HBsAg, HCV Core antigen and HEV RNA).

Description

Inclusion Criteria:

• Acute abdominal pain entailing an abdominal ultrasound or computed tomography for suspected gallstone disease at the emergency room at Sahlgrenska University Hospital, Gothenburg
• Written informed consent
• Ability to obtain 9 mL serum for analysis of anti-HAV IgM, HBsAg, anti-HCV, HCV Core antigen and HEV RNA

Exclusion Criteria:

• Not willing to give written informed consent
• Age below 18 years

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between ongoing viral hepatitis (i.e. hepatitis A, B, C or E virus infection) and ultrasound or computed tomography-verified gallstone disease	The proportion of patient with verified gallstone disease having detectable anti-HAV IgM, HBsAg, HCV Core antigen or HEV RNA will be compared with the proportion among patients without verified gallstone disease.	1 day
Association between ongoing hepatitis A virus infection and ultrasound or computed tomography-verified gallstone disease	The proportion of patient with verified gallstone disease having detectable anti-HAV IgM will be compared with the proportion among patients without verified gallstone disease.	1 day
Association between ongoing hepatitis B virus infection and ultrasound or computed tomography-verified gallstone disease	The proportion of patient with verified gallstone disease having detectable HBsAg will be compared with the proportion among patients without verified gallstone disease.	1 day
Association between ongoing hepatitis C virus infection and ultrasound or computed tomography-verified gallstone disease	The proportion of patient with verified gallstone disease having detectable HCV Core antigen will be compared with the proportion among patients without verified gallstone disease.	1 day
Association between ongoing hepatitis E virus infection and ultrasound or computed tomography-verified gallstone disease	The proportion of patient with verified gallstone disease having detectable HEV RNA will be compared with the proportion among patients without verified gallstone disease.	1 day

Collaborators and Investigators

• Sponsor: Göteborg University
• Investigators: Principal Investigator: Martin Martin, MD PhD, Göteborg University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 15, 2020
• Primary Completion (Anticipated): January 15, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 7, 2020
• First Posted (Actual): January 10, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Liver Diseases; Hepatitis, Viral, Human; Pathological Conditions, Anatomical; Enterovirus Infections; Picornaviridae Infections; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Hepatitis; Hepatitis A; Gallstones; Cholelithiasis; Cholecystolithiasis
• Other Study ID Numbers: VIRGAD

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