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
Change in Serum Citrullinated Histone H3 (H3Cit) Concentration
To evaluate the effect of intraprocedural lidocaine on neutrophil extracellular trap (NET) formation, measured as the change in serum H3Cit concentration (ng/ml). Quantitative analysis of H3Cit will be performed using a commercially available Enzyme-Linked Immunosorbent Assay (ELISA) kit.
Secondary outcomes
Change in Neutrophil-to-Lymphocyte Ratio (NLR)
Calculated as the ratio of absolute neutrophil count divided by the absolute lymphocyte count, obtained from a standard automated complete blood count (CBC).
Change in Serum C-Reactive Protein (CRP) Concentration
Evaluation of the acute-phase inflammatory response measured via standard high-sensitivity serum C-reactive protein laboratory assays.
12-Month Survival Rate
The percentage of patients alive at 12 months post-procedure. Survival status will be verified via clinical database records, in-person clinical follow-up, or telephone contact.
12-Month Disease-Free Survival Rate
The percentage of patients alive without clinical or radiological evidence of local tumor recurrence or distant metastasis. Follow-up oncological status will be confirmed via contrast-enhanced computed tomography (CT), Contrast echocardiography or magnetic resonance imaging (MRI).
Other outcomes
12-Month Local Recurrence Rate
The percentage of patients presenting with new neoplastic activity or active tumor growth at the margin of, or within, the original completely ablated target lesion, confirmed via contrast-enhanced imaging (CT, Contrast echocardiography or MRI)
Sponsors and contacts
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