The Impact of Anaesthesia on Inflammation and NETosis in Hepatocellular Carcinoma Resection

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorIuliu Hatieganu University of Medicine and Pharmacy

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Sedation using combination of Propofol and Fentanyl.

    Drug

    Group 2 received PSA with propofol and fentanyl alone (PF group).

  • Sedation using combination of Propofol and Fentanyl and lidocaine

    Drug

    Group 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

100 Participants
are divided into 2 treatment groups
Group A: Propofol and fentanyl sedationActive comparator 1 intervention
Group B: Propofol plus fentanyl plus lidocaineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to the end of follow up at 1 year

Secondary outcomes

1

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.

Time frame
Evaluations were performed at 24 hours and 1 year post-procedure.

Other outcomes

Sponsors and contacts

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