- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07303829
Laparoscopic Approach to Pyogenic Liver Abscess
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults ≥18 years.
- Radiologically confirmed liver abscess (US/CT/MRI).
- Abscess requiring drainage ≥5 cm,
- Failed or contraindicated percutaneous drainage.
- Recurrence after percutaneous drainage.
Exclusion Criteria:
- Adults ≥18 years.
- Radiologically confirmed liver abscess (US/CT/MRI).
- Abscess requiring drainage ≥5 cm,
- Failed or contraindicated percutaneous drainage.
- Recurrence after percutaneous drainage.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Laproscopic managment
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Major complication rate
Time Frame: 30 days
|
Procedure-related complications (Clavien-Dindo ≥ III) within 30 days.
|
30 days
|
|
Abscess recurrence
Time Frame: 6 months.
|
Recurrence at the same or new site
|
6 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Technical success
Time Frame: 30days
|
Successful laparoscopic drainage and drain placement
|
30days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Whitehead 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.
- 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.
- Teresi 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.
- Julious 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 record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LMPLA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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