Clinical trial · Interventional
The Impact of Anaesthesia and Sedation on Inflammation and NETosis in Hepatocellular Carcinoma Ablation
The Impact of Anaesthesia on Inflammation and NETosis in Hepatocellular Carcinoma Resection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ablation Techniques | — | UNRESOLVED | — |
| Hepato Cellular Carcinoma (HCC) | — | UNRESOLVED | — |
| Sedation and Analgesia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sedation using combination of Propofol and Fentanyl. | Drug | — | UNRESOLVED |
| Sedation using combination of Propofol and Fentanyl and lidocaine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Propofol and fentanyl sedation
- description
- This group receives procedural sedation and analgesia acording to ASA guidlines with propofol and fentanyl alone.
- interventionNames
- Drug: Sedation using combination of Propofol and Fentanyl.
- type
- EXPERIMENTAL
- label
- Propofol plus fentanyl plus lidocaine
- description
- This group receives a procedural sedation and analgesia 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).
- interventionNames
- Drug: Sedation using combination of Propofol and Fentanyl and lidocaine
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * patients with a hepatocellular carcinoma suitable for RFA * tumor measuring up to 3 cm in diameter * ASA I, II, or III Exclusion Criteria: * 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
References
Publications (9)
- RESULTFoo I, Macfarlane AJR, Srivastava D, Bhaskar A, Barker H, Knaggs R, Eipe N, Smith AF. The use of intravenous lidocaine for postoperative pain and recovery: international consensus statement on efficacy and safety. Anaesthesia. 2021 Feb;76(2):238-250. doi: 10.1111/anae.15270. Epub 2020 Nov 3. PMID 33141959
- RESULTChu KF, Dupuy DE. Thermal ablation of tumours: biological mechanisms and advances in therapy. Nat Rev Cancer. 2014 Mar;14(3):199-208. doi: 10.1038/nrc3672. PMID 24561446
- RESULTWee IJY, Moe FNN, Sultana R, Ang RWT, Quek PPS, Goh BKP, Chan CY, Cheow PC, Chung AYF, Jeyaraj PR, Koh YX, Mack POP, Ooi LLPJ, Tan EK, Teo JY, Kam JH, Chua JSS, Ng AWY, Goh JSQ, Chow PKH. Extending Surgical Resection for Hepatocellular Carcinoma Beyond Barcelona Clinic for Liver Cancer (BCLC) Stage A: A Novel Application of the Modified BCLC Staging System. J Hepatocell Carcinoma. 2022 Aug 17;9:839-851. doi: 10.2147/JHC.S370212. eCollection 2022. PMID 35999856
- RESULTForner A, Reig ME, de Lope CR, Bruix J. Current strategy for staging and treatment: the BCLC update and future prospects. Semin Liver Dis. 2010 Feb;30(1):61-74. doi: 10.1055/s-0030-1247133. Epub 2010 Feb 19. PMID 20175034
- RESULTMcBrien M, Thomas ML. Unilateral renal dysplasia in the adult. Br J Urol. 1971 Aug;43(4):387-90. doi: 10.1111/j.1464-410x.1971.tb12057.x. No abstract available. PMID 5095567
- RESULTFacciorusso A. Drug-eluting beads transarterial chemoembolization for hepatocellular carcinoma: Current state of the art. World J Gastroenterol. 2018 Jan 14;24(2):161-169. doi: 10.3748/wjg.v24.i2.161. PMID 29375202
- RESULTBray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.