An Observational Study of Risk Factors and Long-term Prognosis of Patients With Liver Abscess in the "Real-world"

Recruiting

• Conditions: Liver Abscess, Pyogenic; Infections; Abscess; Liver Abscess

• Registration Number: NCT05213949
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

Pyogenic liver abscess is one of the most common visceral abscesses, its incidence is increasing worldwide. According to the previous literature, the mortality rate of pyogenic liver abscess is as high as 31% and become a serious social health problem. However, the data of prospective observational real-world studies are scarce and no relevant research of the liver histological change has been reported, so the long-term prognosis and the risk factors for pyogenic liver abscess are still unknown. Patients will be followed up prospectively for a period of 2 years and observed clinical prognosis (all-cause mortality, the recurrence rate, and the rehospitalization rate). The investigators will investigate the predictive value of clinical risk factors for clinical prognosis and establish clinical prediction models to predict the long-term prognosis of pyogenic liver abscesses.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-30
• Study Start: 2022-01-01
• Study First Submitted QC: 2022-01-17
• Study First Posted: 2022-01-28
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-05
• Last Update Posted: 2022-08-08
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Patients older than 18 years of age;
• Irrespective of gender;
• Symptomatic patients of liver abscess confirmed with radiology imaging, either by ultrasonography or computed tomography scan.

Exclusion Criteria

• Patients <18 years old;
• Pregnancy at presentation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion and causes of deaths within 2 years of discharge from hospital	2 years	Define the proportion and causes of deaths within 2 years of discharge from hospital for patients admitted to the Department for pyogenic liver abscesses.
Proportion and causes of re-hospitalization within 2 years of discharge from hospital	2 years	Define the proportion and causes of re-hospitalization within 2 years of discharge from hospital for patients admitted to the Department for pyogenic liver abscesses.

Secondary Outcome Measures

Name	Time	Method
The recurrence rate of pyogenic liver abscess	2 years	Development new liver abscess after clinical cure during the 2 years follow up period
The number of participants with Histological Change in the Liver	2 years	Assessment of histological change in the liver by using ultrasonography or transient elastography during the 2 years follow up period

Trial Locations

Locations (1)

NanFang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China