Liver Abscess, PyogenicNCT07303829
Laparoscopic Approach to Pyogenic Liver Abscess
A study testing Laproscopic in people with Liver Abscess, Pyogenic, run by Assiut University.
Trial summary
Assess the efficacy and safety of laparoscopic management of liver abscess in achieving complete drainage and clinical recovery compared to conventional open or percutaneous methods, and to: 1. To evaluate postoperative complications and recurrence rates. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Abscess, Pyogenic
- What is being tested?
- Laproscopic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Jan 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years.
- Radiologically confirmed liver abscess (US/CT/MRI).
- Abscess requiring drainage ≥5 cm,
- Failed or contraindicated percutaneous drainage.
- Recurrence after percutaneous drainage.
Who cannot join
- Adults ≥18 years.
- Radiologically confirmed liver abscess (US/CT/MRI).
- Abscess requiring drainage ≥5 cm,
- Failed or contraindicated percutaneous drainage.
- Recurrence after percutaneous drainage.
About this study
Official title: Laproscopic Managment of Pyogenic Liver Abscess
Assess the efficacy and safety of laparoscopic management of liver abscess in achieving complete drainage and clinical recovery compared to conventional open or percutaneous methods, and to:
- To evaluate postoperative complications and recurrence rates.
- To compare hospital stay, recovery time, and overall morbidity.
- To determine patient outcomes and cost-effectiveness of laparoscopic intervention.
Read the detailed description
Liver abscess is a localized collection of pus within the liver parenchyma, most commonly resulting from bacterial or amoebic infection. It remains a serious clinical condition requiring timely diagnosis and effective management to prevent complications such as sepsis or rupture. Traditionally, open surgical drainage was the standard treatment for complicated or multiloculated abscesses and in cases where percutaneous drainage failed. However, advances in minimally invasive surgery have introduced laparoscopic drainage as a safer and more efficient alternative.
Laparoscopic management offers several advantages, including smaller incisions, reduced postoperative pain, shorter hospital stays, and faster recovery compared to open surgery. Moreover, it allows direct visualization of the abscess cavity, facilitates breaking of loculations, debridement of necrotic tissue, and precise placement of drainage catheters. These features enhance the completeness of drainage and reduce recurrence rates.
Recent studies have demonstrated the efficacy of laparoscopic drainage, particularly in large, complex, or multiloculated liver abscesses where percutaneous methods are unsuccessful or contraindicated. A meta-analysis of 17 studies involving 608 patients reported a recurrence rate of only 4.22% with no procedure-related mortality in the laparoscopic group. Consequently, laparoscopic drainage is now considered a step-up approach in the management algorithm of liver abscess, bridging the gap between percutaneous and open surgical techniques, while ensuring optimal clinical outcomes and reduced morbidity.
- Conditions
- Liver Abscess, Pyogenic
- Being tested
- Laproscopic
- Medical subject headings
- Liver Abscess, Pyogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaproscopicDevice
Laparoscopic management uses minimally invasive trocar access with camera-guided drainage and debridement, allowing precise abscess evacuation, reduced tissue trauma, faster recovery, and lower postoperative pain compared with open surgery or percutaneous drainage used in other studies.
| Study group | Role | What they receive |
|---|---|---|
| Laproscopic managment | Experimental | Not described Receives: Device: Laproscopic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major complication rate
Procedure-related complications (Clavien-Dindo ≥ III) within 30 days.
Measured: 30 days
Abscess recurrence
Recurrence at the same or new site
Measured: 6 months.
Secondary outcomes (1)
Technical success
Successful laparoscopic drainage and drain placement
Measured: 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Liver Abscess, PyogenicStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebram Nashat Bastawroos Zakaria, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303829
- Sponsor's protocol ID
- LMPLA
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ndong A, Tendeng JN, Diallo AC, Dieye A, Diao ML, Diallo S, Diop S, Diallo MK, Diedhiou M, Fall ML, Ma Nyemb PM, Konate I. Efficacy of laparoscopic surgery in the treatment of hepatic abscess: A systematic review and meta-analysis. Ann Med Surg (Lond). 2022 Jan 31;75:103308. doi: 10.1016/j.amsu.2022.103308. eCollection 2022 Mar.
PubMed 35198179Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022 Jan 1;60(1):95-103. doi: 10.1097/MLR.0000000000001664.
PubMed 34812790Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
PubMed 26092476Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat. 2005;4(4):287-291.
International Journal of Surgery. Laparoscopic Drainage of Pyogenic Liver Abscess: A Feasible Alternative. https://www.ijsurgery.com/index.php/isj/article/view/9473
Bansal V, et al. Systematic Review of Laparoscopic Drainage of Liver Abscess. Cureus. 2022;14(2):e22045. https://pmc.ncbi.nlm.nih.gov/articles/PMC8850317
Saravanan R, et al. Comparative Study of Laparoscopic Versus Open Surgical Drainage in Pyogenic Liver Abscess. SAR J Surg. 2024. https://sarpublication.com/media/articles/SARJS_62_10-14.pdf
Medscape. Liver Abscess Treatment & Management. https://emedicine.medscape.com/article/188802-treatment
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laproscopic Managment of Pyogenic Liver Abscess
- ClinicalTrials.gov ID
- NCT07303829
- Acronym / sponsor ID
- LMPLA
- Conditions
- Liver Abscess, Pyogenic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 26 Dec 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.
Assess the efficacy and safety of laparoscopic management of liver abscess in achieving complete drainage and clinical recovery compared to conventional open or percutaneous methods, and to:
- To evaluate postoperative complications and recurrence rates.
- To compare hospital stay, recovery time, and overall morbidity.
- To determine patient outcomes and cost-effectiveness of laparoscopic intervention.
Detailed description
Liver abscess is a localized collection of pus within the liver parenchyma, most commonly resulting from bacterial or amoebic infection. It remains a serious clinical condition requiring timely diagnosis and effective management to prevent complications such as sepsis or rupture. Traditionally, open surgical drainage was the standard treatment for complicated or multiloculated abscesses and in cases where percutaneous drainage failed. However, advances in minimally invasive surgery have introduced laparoscopic drainage as a safer and more efficient alternative.
Laparoscopic management offers several advantages, including smaller incisions, reduced postoperative pain, shorter hospital stays, and faster recovery compared to open surgery. Moreover, it allows direct visualization of the abscess cavity, facilitates breaking of loculations, debridement of necrotic tissue, and precise placement of drainage catheters. These features enhance the completeness of drainage and reduce recurrence rates.
Recent studies have demonstrated the efficacy of laparoscopic drainage, particularly in large, complex, or multiloculated liver abscesses where percutaneous methods are unsuccessful or contraindicated. A meta-analysis of 17 studies involving 608 patients reported a recurrence rate of only 4.22% with no procedure-related mortality in the laparoscopic group. Consequently, laparoscopic drainage is now considered a step-up approach in the management algorithm of liver abscess, bridging the gap between percutaneous and open surgical techniques, while ensuring optimal clinical outcomes and reduced morbidity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laproscopic managment | Experimental | Device: Laproscopic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults ≥18 years.
- Radiologically confirmed liver abscess (US/CT/MRI).
- Abscess requiring drainage ≥5 cm,
- Failed or contraindicated percutaneous drainage.
- Recurrence after percutaneous drainage.
Key exclusion criteria (5 listed)
- Adults ≥18 years.
- Radiologically confirmed liver abscess (US/CT/MRI).
- Abscess requiring drainage ≥5 cm,
- Failed or contraindicated percutaneous drainage.
- Recurrence after percutaneous drainage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaproscopicLaparoscopic management uses minimally invasive trocar access with camera-guided drainage and debridement, allowing precise abscess evacuation, reduced tissue trauma, faster recovery, and lower postoperative pain compared with open surgery or percutaneous drainage used in other studies. | Device | Laproscopic managment |
Primary outcome
Major complication rate
Time frame: 30 days
Procedure-related complications (Clavien-Dindo ≥ III) within 30 days.
Abscess recurrence
Time frame: 6 months.
Recurrence at the same or new site
1 secondary outcome
Technical success
Time frame: 30days
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 26 Dec 2025.
- Results publication: PubMed 35198179Ndong A, Tendeng JN, Diallo AC, Dieye A, Diao ML, Diallo S, Diop S, Diallo MK, Diedhiou M, Fall ML, Ma Nyemb PM, Konate I. Efficacy of laparoscopic surgery in the treatment of hepatic abscess: A systematic review and meta-analysis. Ann Med Surg (Lond). 2022 Jan 31;75:103308. doi: 10.1016/j.amsu.2022.103308. eCollection 2022 Mar.
- Results publication: PubMed 34812790Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022 Jan 1;60(1):95-103. doi: 10.1097/MLR.0000000000001664.
- Results publication: PubMed 26092476Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
- Results publicationJulious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat. 2005;4(4):287-291.
- Results publicationInternational Journal of Surgery. Laparoscopic Drainage of Pyogenic Liver Abscess: A Feasible Alternative. https://www.ijsurgery.com/index.php/isj/article/view/9473
- Results publicationBansal V, et al. Systematic Review of Laparoscopic Drainage of Liver Abscess. Cureus. 2022;14(2):e22045. https://pmc.ncbi.nlm.nih.gov/articles/PMC8850317
- Results publicationSaravanan R, et al. Comparative Study of Laparoscopic Versus Open Surgical Drainage in Pyogenic Liver Abscess. SAR J Surg. 2024. https://sarpublication.com/media/articles/SARJS_62_10-14.pdf
- Results publicationMedscape. Liver Abscess Treatment & Management. https://emedicine.medscape.com/article/188802-treatment
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Laproscopic in people with Liver Abscess, Pyogenic, 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 5 inclusion and 5 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 26 Dec 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major complication rate (time frame: 30 days). The study lists 2 primary outcomes in all. 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 NCT07303829, which also lists 8 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 26 Dec 2025.