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NCT03598465

Evaluating the Association Between Sphingolipid Metabolites and Post-hepatectomy Liver Failure

Completed Last updated 14 November 2024
What this trial tests

trial in Post-hepatectomy Liver Failure in 591 participants. Completed in 1 October 2024.

Timeline
5 March 2019
Primary endpoint
1 September 2024
1 October 2024

Quick facts

Lead sponsorNanfang Hospital, Southern Medical University
StatusCompleted
Study typeOBSERVATIONAL
Enrollment591
Start date5 March 2019
Primary completion1 September 2024
Estimated completion1 October 2024
Sites3 locations across China

Conditions studied

Sponsor

Nanfang Hospital, Southern Medical University

Who can join

Adults 18 to 80, any sex, with Post-hepatectomy Liver Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hepatectomy is an essential treatment for various benign and malignant diseases of the liver. However, post-hepatectomy liver failure (PHLF) is still a life-threatening complication after hepatectomy. The pathophysiological mechanism of PHLF has not yet been fully elucidated, and there is still a lack of effective strategies for either prevention or therapy of PHLF. Sphingolipids include ceramides (CER), sphingomyelins (SM), glycosphingolipids (GSL), sphingosine (SPH), and sphingosine-1-phosphate (S1P) are multi-functional lipids that regulates cell proliferation, cell survival, cell death, inflammation, tissue fibrosis, cancer cell metastasis, and invasion. Liver is a main organ for metabolizing sphingolipids, dysregulation of specific sphingolipids is associated with several liver diseases, therefore sphingolipids have been proposed to be biomarkers of liver diseases, including hepatitis, liver cancer, fatty liver diseases, and liver fibrosis. Moreover, several studies have shown CER, SPH and S1P are critical in regulating pathophysiology of liver diseases, including liver regeneration, necrosis, and inflammation. Given that PHLF causes dramatic dysregulation in biochemical metabolism in liver, the investigators hypothesize that dysregulation of sphingolipid metabolism may also occur in PHLF, and the dysregulation of specific sphingolipids may serve as a biomarker or regulator during progression and recovery of PHLF. This project will examine the association between sphingolipid metabolism and PHLF. Levels of sphingolipid metabolites and their related enzymes in plasma and liver tissue of patients with hepatic resection will be measured by using liquid chromatograph/electrospray ionization/mass spectrometry (LC-ESI-MS/MS) and high-throughput real-time quantitative PCR. This project will facilitate us to identify specific sphingolipid metabolites as biomarker and regulator of PHLF.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Prospective multicenter validation of preoperative plasma ceramides as novel predictive biomarkers for clinically relevant post-hepatectomy liver failure.
    Liang H, Liu H, Li J, Wang B, et al · · 2025 · cited 1× · PMID 40557443 · DOI 10.1097/js9.0000000000002791

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