Clinical trial · Interventional
Evaluation Of The Influence Of Anesthetic Interventions On The Evolution Of Hepatic Neoplastic Processes
NCT07207304CI-TRIAL-00115655completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Evaluation Of The Influence Of Anesthetic Interventions On The Evolution Of Hepatic Neoplastic Processes The goal of this clinical trial is to evaluate of the involvement of Neutrophil extracellular traps in the evolution of hepatocellular cancer. The main questions it aims to answer are: * How does the type of anesthesia used in hepatobiliary oncological surgery influence postoperative evolution and the immune response? * How does the type of anesthesia, TIVA versus inhalational influence the generation of neutrophil extracellular traps (NETs)? Researchers will compare the evolution of the patients assigned to 4 study groups depending on the anesthetic intervention performed. Participants will: * will be evaluated pre and postanesthesia, blood samples will be collected for analysis of the inflammatory response * will be followed up one year for establishing the outcome
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anesthesia | — | UNRESOLVED | — |
| Hepato-cellular Carcinoma | Hepatocellular Carcinoma | PROBABILISTIC | 0.70 |
| Lidocaine Infusion | — | UNRESOLVED | — |
| Neutrophil Extracellular Trap Formation | — | UNRESOLVED | — |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anesthesia | Procedure | — | UNRESOLVED |
| Anesthesia induction with TCI | Procedure | — | UNRESOLVED |
| Bispectral Index (BIS) | Device | — | UNRESOLVED |
| Blood sampling | Procedure | — | UNRESOLVED |
| Intraoperative analgesia | Drug | — | UNRESOLVED |
| Intraoperative mechanical ventilation | Procedure | — | UNRESOLVED |
| Lidocaine Infusion | Drug | — | UNRESOLVED |
| Morphine (+) | Drug | — | UNRESOLVED |
| Non-opioid analgesics |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Hepatocellular carcinoma (HCC) resection performed under total intravenous anesthesia (TIVA)
- description
- Patients will receive total intravenous anesthesia (TIVA) with 1% propofol, administered using the Schneider pharmacokinetic model. The initial target effect-site concentration will be 4 µg/mL, titrated intraoperatively to maintain a BIS value between 40 and 59.
- interventionNames
- Procedure: Anesthesia
- Procedure: Anesthesia induction with TCI
- Drug: Intraoperative analgesia
- Drug: Non-opioid analgesics
- Drug: Morphine (+)
- Device: Bispectral Index (BIS)
- Procedure: Intraoperative mechanical ventilation
- Procedure: Blood sampling
- type
- ACTIVE_COMPARATOR
- label
- HCC resection performed under sevoflurane anesthesia
- description
- Patients will receive volatile anesthesia with sevoflurane, maintained at an end-tidal concentration (EtSevo) corresponding to 1.0-1.5 MAC. The concentration will be adjusted in increments or decrements of 0.25-0.5 MAC to maintain a BIS value between 40 and 59.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with: hepatocellular carcinoma, or hepatic metastases * Scheduled for elective liver surgery: Exclusion Criteria: * Undergoing emergency surgery * Barcelona-Clinic Liver Cancer stage C; * Child-Pugh Class C * Receiving chronic immunosuppressive therapy * Having contraindications to any of the study medications * Diagnosed with psychiatric disorders, such as: depression, bipolar disorder, schizophrenia, having autoimmune diseases * Suffering from corticosteroid-dependent bronchial asthma * Diagnosed with congenital or acquired coagulation disorders
References
Publications (7)
- BACKGROUNDTohme S, Yazdani HO, Al-Khafaji AB, Chidi AP, Loughran P, Mowen K, Wang Y, Simmons RL, Huang H, Tsung A. Neutrophil Extracellular Traps Promote the Development and Progression of Liver Metastases after Surgical Stress. Cancer Res. 2016 Mar 15;76(6):1367-80. doi: 10.1158/0008-5472.CAN-15-1591. Epub 2016 Jan 12. PMID 26759232
- BACKGROUNDZhao H, Wu L, Yan G, Chen Y, Zhou M, Wu Y, Li Y. Inflammation and tumor progression: signaling pathways and targeted intervention. Signal Transduct Target Ther. 2021 Jul 12;6(1):263. doi: 10.1038/s41392-021-00658-5. PMID 34248142
- BACKGROUNDZhang W, Liu J, Li X, Bai Z, Sun Y, Chen X. Lidocaine effects on neutrophil extracellular trapping and angiogenesis biomarkers in postoperative breast cancer patients with different anesthesia methods: a prospective, randomized trial. BMC Anesthesiol. 2024 Apr 27;24(1):162. doi: 10.1186/s12871-024-02540-7. PMID 38678209
- BACKGROUNDCata JP, Sood AK, Eltzschig HK. Anesthetic Drugs and Cancer Progression. Anesthesiology. 2020 Oct 1;133(4):698-699. doi: 10.1097/ALN.0000000000003510. No abstract available. PMID 32833387
- BACKGROUNDRamirez MF, Cata JP. Anesthetic care influences long-term outcomes: What is the evidence? Best Pract Res Clin Anaesthesiol. 2021 Dec;35(4):491-505. doi: 10.1016/j.bpa.2021.01.004. Epub 2021 Feb 3. PMID 34801212
- BACKGROUNDAllaire M, Goumard C, Lim C, Le Cleach A, Wagner M, Scatton O. New frontiers in liver resection for hepatocellular carcinoma. JHEP Rep. 2020 Jun 4;2(4):100134. doi: 10.1016/j.jhepr.2020.100134. eCollection 2020 Aug. PMID 32695968
- BACKGROUNDAsrani SK, Devarbhavi H, Eaton J, Kamath PS. Burden of liver diseases in the world. J Hepatol. 2019 Jan;70(1):151-171. doi: 10.1016/j.jhep.2018.09.014. Epub 2018 Sep 26.