RecruitingNot ApplicableNCT07657897

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


Sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Enrollment

100 participants

Start Date

Nov 12, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

  • patients with a hepatocellular carcinoma suitable for RFA
  • tumor measuring up to 3 cm in diameter
  • ASA I, II, or III

Exclusion Criteria10

  • candidates for surgery
  • chronic immunosuppressive medication
  • contraindications to any of the study medications
  • patients with psychiatric disorders
  • autoimmune disorders
  • corticosteroid-dependent bronchial asthma
  • congenital or acquired coagulation disorders
  • HIV-positive patients
  • pregnant women
  • antiarrhythmic therapy

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Interventions

DRUGSedation using combination of Propofol and Fentanyl.

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

DRUGSedation using combination of Propofol and Fentanyl and lidocaine

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)


Locations(1)

"Prof. Dr. Octavian Fodor" Regional Institute of Gastroenterology and Hepatology, Cluj-Napoca, Romania

Cluj-Napoca, Cluj, Romania

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NCT07657897


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