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

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

• Study Contact: Name: Xuyen Xu, MD; Phone Number: 020-62786539; Email: xuxuwen95@126.com
• Study Contact Backup: Name: Muye Xia, MD; Phone Number: +86 17665730806; Email: xiamuye@foxmail.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 5100515
      • Recruiting
      • Nanfang Hospital of Southern Medical University
      • Contact: Xuyen M University, MD; Phone Number: 02062786539; Email: xuxuwen95@126.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

Patients older than 18 years of age admitted for pyogenic liver abscesses

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The recurrence rate of pyogenic liver abscess	Development new liver abscess after clinical cure during the 2 years follow up period	2 years
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

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: December 30, 2021
• First Submitted That Met QC Criteria: January 17, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Actual): August 8, 2022
• Last Update Submitted That Met QC Criteria: August 5, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Pyogenic Liver abscess; Liver histological change
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Inflammation; Liver Diseases; Suppuration; Abdominal Abscess; Abscess; Liver Abscess; Liver Abscess, Pyogenic
• Other Study ID Numbers: NFEC-2021-355

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to share IPD with other researchers except for those are directly involved with this study.

Drug and device information, study documents

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