About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients with a hepatocellular carcinoma suitable for RFA
tumor measuring up to 3 cm in diameter
ASA I, II, or III
Disqualifiers
candidates for surgery
chronic immunosuppressive medication
contraindications to any of the study medications
patients with psychiatric disorders
Trial design
Parallel
Treatments tested in this trial
Sedation using combination of Propofol and Fentanyl.
DrugGroup 2 received PSA with propofol and fentanyl alone (PF group).
Sedation using combination of Propofol and Fentanyl and lidocaine
DrugGroup 1 received a procedural sedation and analgesia (PSA) with propofol and fentanyl, combined with a 1.5 mg/kg slow bolus of lidocaine followed by an intravenous lidocaine infusion of 1 mg/kg/h for 24 hours (PF-L group)
Treatment groups
Trial outcomes
Primary outcomes
Primary endpoints included the assessment of the impact on recurrence rates and survival.
Patient follow-up is conducted through regularly scheduled clinical evaluations with a specialist. At the 1-year post-intervention mark, patients are contacted via telephone to arrange an in-person consultation and assess their overall health status.
Secondary outcomes
Lidocaine impact on inflammation
Secondary outcomes were the assessment of the effect of intravenous lidocaine supplementation on the recurrence rate and on the formation of NETs and their correlation with the incidence of recurrence at 1 year.
Sponsors and contacts
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