NCT07657897 The Impact of Anaesthesia and Sedation on Inflammation and NETosis in Hepatocellular Carcinoma Ablation
| NCT ID | NCT07657897 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Iuliu Hatieganu University of Medicine and Pharmacy |
| Condition | Hepato Cellular Carcinoma (HCC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-11-12 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-11-12 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Frequently Asked Questions
Who can join the NCT07657897 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Hepato Cellular Carcinoma (HCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07657897 currently recruiting?
Yes, NCT07657897 is actively recruiting participants. Visit ClinicalTrials.gov or contact Iuliu Hatieganu University of Medicine and Pharmacy to inquire about joining.
Where is the NCT07657897 trial being conducted?
This trial is being conducted at Cluj-Napoca, Romania.
Who is sponsoring the NCT07657897 clinical trial?
NCT07657897 is sponsored by Iuliu Hatieganu University of Medicine and Pharmacy. The trial plans to enroll 100 participants.