VIRal Hepatitis and GAllstone Disease Study

Viral Hepatitis Clinical Trial

— VIRGAD  

Official title:

Viral Hepatitis and Gallstone Disease Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04222803
• Other study ID #: VIRGAD
• Status: Not yet recruiting
• Start date: January 15, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: January 2020
• Source: Göteborg University
• Contact: Martin Martin, MD PhD
• Phone: +46-(0)705-68 37 59
• Email: martin.lagging[@]medfak.gu.se
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: June 1, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstone Attack
• Gallstones
• Hepatitis
• Hepatitis A
• Viral Hepatitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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