NCT05213949

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

August 8, 2022

Status Verified

August 1, 2022

Enrollment Period

3 years

First QC Date

December 30, 2021

Last Update Submit

August 5, 2022

Conditions

Keywords

Pyogenic Liver abscessLiver histological change

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • The recurrence rate of pyogenic liver abscess

    2 years

  • The number of participants with Histological Change in the Liver

    2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NanFang Hospital of Southern Medical University

Guangzhou, Guangdong, 5100515, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Take 10ml blood sample for each patient

MeSH Terms

Conditions

Liver Abscess, PyogenicLiver AbscessAbscessInfections

Condition Hierarchy (Ancestors)

Abdominal AbscessSuppurationLiver DiseasesDigestive System DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2021

First Posted

January 28, 2022

Study Start

January 1, 2022

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

August 8, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

There is no plan to share IPD with other researchers except for those are directly involved with this study.

Locations