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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05213949
Other study ID # NFEC-2021-355
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date January 1, 2025

Study information

Verified date August 2022
Source Nanfang Hospital of Southern Medical University
Contact Xuyen Xu, MD
Phone 020-62786539
Email xuxuwen95@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date January 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
China NanFang Hospital of Southern Medical University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion and causes of deaths within 2 years of discharge from hospital Define the proportion and causes of deaths within 2 years of discharge from hospital for patients admitted to the Department for pyogenic liver abscesses. 2 years
Primary Proportion and causes of re-hospitalization within 2 years of discharge from hospital 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. 2 years
Secondary The recurrence rate of pyogenic liver abscess Development new liver abscess after clinical cure during the 2 years follow up period 2 years
Secondary The number of participants with Histological Change in the Liver Assessment of histological change in the liver by using ultrasonography or transient elastography during the 2 years follow up period 2 years
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