Liver AbscessNCT06852235
Characteristics and Treatment Outcome of Liver Abscesses: An Observational Study
An observational study of Liver Abscess, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Abscess
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2025to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: All patients diagnosed with liver abscess according to inclusion and exclusion criteria.
Who may be able to join
- 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.
Who cannot join
- Liver abscess that occurs secondary to hydatid cyst.
- Liver abscess associated with underlying malignancy.
- Patient with incomplete medical records.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
- To assess the frequency, clinical presentation, microbiological and radiological characteristics of liver abscesses.
- To evaluate the management plan and treatment outcome of liver abscess.
- To study risk factors of liver abscess.
Read the 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).
- Conditions
- Liver Abscess
- Medical subject headings
- Liver Abscess
What is being measured
The primary outcome is the main question the study is designed to answer.
1. To assess the frequency, clinical picture, microbiological and radiological characteristics of liver abscesses.
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.
Measured: Baseline
Secondary outcomes (2)
2. To evaluate the management plan and treatment outcome of liver abscess.
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.
Measured: Baseline
3. To study risk factors of liver abscess.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start15 Mar 2025 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Liver AbscessStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Magdy Wadie, Assiut University
- Investigators
- Ashraf Mahmoud Othman, doctorate, Study director, Assiut UniversityHaidi Karam-Allah Ramadan, doctorate, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852235
- Sponsor's protocol ID
- Liver abscess
- Status last verified
- Feb 2025
- First submitted
- 22 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ahmed S, Chia CL, Junnarkar SP, Woon W, Shelat VG. Percutaneous drainage for giant pyogenic liver abscess--is it safe and sufficient? Am J Surg. 2016 Jan;211(1):95-101. doi: 10.1016/j.amjsurg.2015.03.002. Epub 2015 May 7.
PubMed 26033361Alkofer B, Dufay C, Parienti JJ, Lepennec V, Dargere S, Chiche L. Are pyogenic liver abscesses still a surgical concern? A Western experience. HPB Surg. 2012;2012:316013. doi: 10.1155/2012/316013. Epub 2012 Feb 19.
PubMed 22536008Baban FA. Clinical characteristic of amoebic liver abscesses in the North of Iraq. Saudi Med J. 2000 Jun;21(6):545-9.
PubMed 11500703Ballas ZK, Uthman SM. Amebic liver abscess in Lebanon. A report of 37 cases and a review of the literature. Am J Proctol. 1973 Jun;24(3):228-36. No abstract available.
PubMed 4707978Chan KS, Chia CTW, Shelat VG. Demographics, Radiological Findings, and Clinical Outcomes of Klebsiella pneumonia vs. Non-Klebsiella pneumoniae Pyogenic Liver Abscess: A Systematic Review and Meta-Analysis with Trial Sequential Analysis. Pathogens. 2022 Aug 26;11(9):976. doi: 10.3390/pathogens11090976.
PubMed 36145408Chiche L, Dargere S, Le Pennec V, Dufay C, Alkofer B. [Pyogenic-liver abscess: diagnosis and management]. Gastroenterol Clin Biol. 2008 Dec;32(12):1077-91. doi: 10.1016/j.gcb.2008.09.019. Epub 2008 Nov 18. French.
PubMed 19019604Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb SA, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including the Pediatric Subgroup. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med. 2013 Feb;41(2):580-637. doi: 10.1097/CCM.0b013e31827e83af.
PubMed 23353941Halvorsen RA, Korobkin M, Foster WL, Silverman PM, Thompson WM. The variable CT appearance of hepatic abscesses. AJR Am J Roentgenol. 1984 May;142(5):941-6. doi: 10.2214/ajr.142.5.941.
PubMed 6372412Huang CJ, Pitt HA, Lipsett PA, Osterman FA Jr, Lillemoe KD, Cameron JL, Zuidema GD. Pyogenic hepatic abscess. Changing trends over 42 years. Ann Surg. 1996 May;223(5):600-7; discussion 607-9. doi: 10.1097/00000658-199605000-00016.
PubMed 8651751Kaplan GG, Gregson DB, Laupland KB. Population-based study of the epidemiology of and the risk factors for pyogenic liver abscess. Clin Gastroenterol Hepatol. 2004 Nov;2(11):1032-8. doi: 10.1016/s1542-3565(04)00459-8.
PubMed 15551257Liu L, Chen W, Lu X, Zhang K, Zhu C. Pyogenic Liver Abscess: A Retrospective Study of 105 Cases in an Emergency Department from East China. J Emerg Med. 2017 Apr;52(4):409-416. doi: 10.1016/j.jemermed.2016.09.026. Epub 2016 Oct 17.
PubMed 27765437McNeil T, Daniel S, Gordon DL. Management of pyogenic liver abscess: a South Australian experience. ANZ J Surg. 2020 Nov;90(11):2274-2278. doi: 10.1111/ans.15963. Epub 2020 May 26.
PubMed 32455495Mohsen AH, Green ST, Read RC, McKendrick MW. Liver abscess in adults: ten years experience in a UK centre. QJM. 2002 Dec;95(12):797-802. doi: 10.1093/qjmed/95.12.797.
PubMed 12454322Mousa H, Al-Bluwi GSM, Al Drini ZFM, Gasmelseed HI, Alkoteesh JA, Babiker ZOE. Importation of Entamoeba histolytica and predominance of Klebsiella pneumoniae in liver abscesses: a 7-year retrospective cohort study from the United Arab Emirates. Trop Dis Travel Med Vaccines. 2021 Jun 12;7(1):17. doi: 10.1186/s40794-021-00140-8.
PubMed 34118991Mucke MM, Kessel J, Mucke VT, Schwarzkopf K, Hogardt M, Stephan C, Zeuzem S, Kempf VAJ, Lange CM. The role of Enterococcus spp. and multidrug-resistant bacteria causing pyogenic liver abscesses. BMC Infect Dis. 2017 Jun 26;17(1):450. doi: 10.1186/s12879-017-2543-1.
PubMed 28651522
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and Treatment Outcome of Liver Abscesses: An Observational Study
- ClinicalTrials.gov ID
- NCT06852235
- Acronym / sponsor ID
- Liver abscess
- Conditions
- Liver Abscess
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To assess the frequency, clinical presentation, microbiological and radiological characteristics of liver abscesses.
- To evaluate the management plan and treatment outcome of liver abscess.
- To study risk factors of liver abscess.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients diagnosed with liver abscess according to inclusion and exclusion criteria.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Liver abscess that occurs secondary to hydatid cyst.
- Liver abscess associated with underlying malignancy.
- Patient with incomplete medical records.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
2. To evaluate the management plan and treatment outcome of liver abscess.
Time frame: Baseline
3. To study risk factors of liver abscess.
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Background: PubMed 26033361Ahmed S, Chia CL, Junnarkar SP, Woon W, Shelat VG. Percutaneous drainage for giant pyogenic liver abscess--is it safe and sufficient? Am J Surg. 2016 Jan;211(1):95-101. doi: 10.1016/j.amjsurg.2015.03.002. Epub 2015 May 7.
- Background: PubMed 22536008Alkofer B, Dufay C, Parienti JJ, Lepennec V, Dargere S, Chiche L. Are pyogenic liver abscesses still a surgical concern? A Western experience. HPB Surg. 2012;2012:316013. doi: 10.1155/2012/316013. Epub 2012 Feb 19.
- Background: PubMed 11500703Baban FA. Clinical characteristic of amoebic liver abscesses in the North of Iraq. Saudi Med J. 2000 Jun;21(6):545-9.
- Background: PubMed 4707978Ballas ZK, Uthman SM. Amebic liver abscess in Lebanon. A report of 37 cases and a review of the literature. Am J Proctol. 1973 Jun;24(3):228-36. No abstract available.
- Background: PubMed 36145408Chan KS, Chia CTW, Shelat VG. Demographics, Radiological Findings, and Clinical Outcomes of Klebsiella pneumonia vs. Non-Klebsiella pneumoniae Pyogenic Liver Abscess: A Systematic Review and Meta-Analysis with Trial Sequential Analysis. Pathogens. 2022 Aug 26;11(9):976. doi: 10.3390/pathogens11090976.
- Background: PubMed 19019604Chiche L, Dargere S, Le Pennec V, Dufay C, Alkofer B. [Pyogenic-liver abscess: diagnosis and management]. Gastroenterol Clin Biol. 2008 Dec;32(12):1077-91. doi: 10.1016/j.gcb.2008.09.019. Epub 2008 Nov 18. French.
- Background: PubMed 23353941Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb SA, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including the Pediatric Subgroup. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med. 2013 Feb;41(2):580-637. doi: 10.1097/CCM.0b013e31827e83af.
- Background: PubMed 6372412Halvorsen RA, Korobkin M, Foster WL, Silverman PM, Thompson WM. The variable CT appearance of hepatic abscesses. AJR Am J Roentgenol. 1984 May;142(5):941-6. doi: 10.2214/ajr.142.5.941.
- Background: PubMed 8651751Huang CJ, Pitt HA, Lipsett PA, Osterman FA Jr, Lillemoe KD, Cameron JL, Zuidema GD. Pyogenic hepatic abscess. Changing trends over 42 years. Ann Surg. 1996 May;223(5):600-7; discussion 607-9. doi: 10.1097/00000658-199605000-00016.
- Background: PubMed 15551257Kaplan GG, Gregson DB, Laupland KB. Population-based study of the epidemiology of and the risk factors for pyogenic liver abscess. Clin Gastroenterol Hepatol. 2004 Nov;2(11):1032-8. doi: 10.1016/s1542-3565(04)00459-8.
- Background: PubMed 27765437Liu L, Chen W, Lu X, Zhang K, Zhu C. Pyogenic Liver Abscess: A Retrospective Study of 105 Cases in an Emergency Department from East China. J Emerg Med. 2017 Apr;52(4):409-416. doi: 10.1016/j.jemermed.2016.09.026. Epub 2016 Oct 17.
- Background: PubMed 32455495McNeil T, Daniel S, Gordon DL. Management of pyogenic liver abscess: a South Australian experience. ANZ J Surg. 2020 Nov;90(11):2274-2278. doi: 10.1111/ans.15963. Epub 2020 May 26.
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Liver Abscess
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashraf Mahmoud Othman, doctorate study director
Assiut University
Haidi Karam-Allah Ramadan, doctorate study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Abscess, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco Magdy, Bachelor (01270777143, marcomagdy1997@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. To assess the frequency, clinical picture, microbiological and radiological characteristics of liver abscesses. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06852235, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.