Characteristics and Treatment Outcome of Liver Abscesses: An Observational Study

February 26, 2025 updated by: Marco Magdy Wadie, Assiut University
  1. To assess the frequency, clinical presentation, microbiological and radiological characteristics of liver abscesses.
  2. To evaluate the management plan and treatment outcome of liver abscess.
  3. To study risk factors of liver abscess.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

There is a paucity of information on liver abscesses' epidemiology and characteristics in the Middle East in general and Egypt in particular.

The incidence of liver abscess varies from one country to another. The annual incidence of pyogenic liver abscess has been estimated at 2.3 cases per 100,000 populations and 18-20 per 100 000 hospital admissions (Mohsen et al 2002, Kaplan et al 2004).

Liver abscess is a potentially life-threatening condition (Ahmed et al., 2016).

A review by Chan KS et al. of 16 pyogenic LA (PLA) articles showed mortality rates ranging from 0% to 15.7 % (Chan et al., 2022).

The etiology of LA can be bacterial (most often polymicrobial), parasitic (amebic essentially), mixed (pyogenic superinfection of parasitic abscess) or more rarely fungal (Nakanishi et al., 2009).

Microbes can invade the liver parenchyma by way of the bile ducts, blood stream (hematogenic, most often portal), or by contiguous spread, especially via the gallbladder bed (Yoo et al., 1993, Thomsen et al., 2007).

Advanced age, diabetes mellitus (DM) and the presence of underlying malignancy are considered major risk factors, and the latter is associated with a worse prognosis (Yoo et al., 1993, Thomsen et al., 2007).

The number of cryptogenic liver abscess cases has been on the rise, and no predisposing conditions (cryptogenic) was reported in 18% (McNeil et al. 2020).

The diagnosis of LA relies essentially on imaging. Sonography and CT scan lead to diagnosis in more than 90% of cases (Halvorsen et al., 1984).

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All patients diagnosed with liver abscess according to inclusion and exclusion criteria.

Description

Inclusion Criteria:

  • Diagnosis of LA will be based on typical appearance on ultrasound (US) or computed tomography (CT) of abdomen with clinical features consistent with the diagnosis (fever, chills, jaundice, right upper quadrant pain/epigastric discomfort).
  • US or CT-guided aspiration of pus from a hepatic lesion.
  • Complete resolution of radiological abnormalities following antimicrobial therapy.

Exclusion Criteria:

  • Liver abscess that occurs secondary to hydatid cyst.
  • Liver abscess associated with underlying malignancy.
  • Patient with incomplete medical records.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. To assess the frequency, clinical picture, microbiological and radiological characteristics of liver abscesses.
Time Frame: Baseline

Data will be statistically evaluated by SPSS version 22. Numerical data will be expressed as means ± SDs.

Categorical data will be expressed as frequencies (percentages).

Comparison between groups will be conducted using t-test or Chi square test as appropriate.

P value <0.05 will be considered as significant.

Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2. To evaluate the management plan and treatment outcome of liver abscess.
Time Frame: Baseline

Data will be statistically evaluated by SPSS version 22. Numerical data will be expressed as means ± SDs.

Categorical data will be expressed as frequencies (percentages).

Comparison between groups will be conducted using t-test or Chi square test as appropriate.

P value <0.05 will be considered as significant.

Baseline
3. To study risk factors of liver abscess.
Time Frame: Baseline

Data will be statistically evaluated by SPSS version 22. Numerical data will be expressed as means ± SDs.

Categorical data will be expressed as frequencies (percentages).

Comparison between groups will be conducted using t-test or Chi square test as appropriate.

P value <0.05 will be considered as significant.

Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Ashraf Mahmoud Othman, doctorate, Assiut University
  • Study Director: Haidi Karam-Allah Ramadan, doctorate, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

February 22, 2025

First Submitted That Met QC Criteria

February 26, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

February 1, 2025

More Information

Terms related to 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Abscess

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