Clinical Trial

The Impact of Anaesthesia and Sedation on Inflammation and NETosis in Hepatocellular Carcinoma Ablation

Recruiting
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Summary
According to recent literature, liver disease causes approximately 2 million deaths annually; 1 million are attributed to the complications of cirrhosis, while the remaining deaths are caused by hepatocellular carcinoma (HCC). The latter currently ranks 16th among the leading causes of death worldwide. Current research focuses on investigating novel therapeutic modalities, optimizing surgical and anesthetic practices, and identifying biological biomarkers to predict disease progression and severity. In this study, we address radiofrequency ablation (RFA) with the goal of improving periprocedural prognosis, recurrence rates, and overall survival. Specifically, we will quantify the expression of NETosis, a relatively novel biomarker with potential therapeutic and prognostic value in HCC progression. NETosis is a regulated form of cell death through which granulocytes release decondensed chromatin and various proteases into the extracellular space, forming a web-like meshwork known as neutrophil extracellular traps (NETs). These structures are actively involved in hepatic tumorigenesis by promoting tumor growth and metastasis. Recent clinical data reveal that NETs play a key role in: Local tumor progression The incidence of hepatic metastasis Direct modulation of the immune response Hepatic ischemia-reperfusion injury Several recent studies demonstrate that the in vivo blockade of NETosis reduces tumor recurrence, mitigates the pro-inflammatory state, and serves as a valuable prognostic indicator in advanced liver disease \[2,3,4\]. To suppress NETosis expression and ultimately lower recurrence rates, our protocol evaluates the intraprocedural administration of 1% lidocaine followed by a continuous postoperative intravenous lidocaine infusion.
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-07-22
Trial Details
NCT Number NCT07657897
Lead Sponsor Iuliu Hatieganu University of Medicine and Pharmacy
Conditions Hepato Cellular Carcinoma (HCC), Sedation and Analgesia, Ablation Techniques
Enrollment 100 participants
Start Date 2024-11-12
Primary Completion 2026-03-31 (estimated)
Study Completion 2026-11-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-21