Clinical trial NCT04510935: Effects of Anesthetic Methods on Hepatic Cancer Cell Function in Vitro
Official title: Effects of Serum From Hepatocellular Carcinoma Surgery Patients Under Different Anesthetic Methods on Hepatic Cancer Cell Function in Vitro
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Numerous studies find that anesthetic methods may influence the recurrence of tumor and the overall survival of patients after primary cancer surgery. Radiofrequency (RF) ablation is now widely used in the clinic for treatment of hepatocellular carcinoma (HCC). Currently, diverse anesthetic methods, including general anesthesia (GA), epidural anesthesia and local anesthesia (LA), are used for RF ablation surgery. Using serum from HCC surgery patients randomized to receive either GA or LA during surgery, we will investigate the effects of anesthetic methods on cellular invasion, migration and proliferation of HepG2 hepatic cancer cells in vitro. The expression levels of inflammatory cytokines in the serum from patients of both groups will also be analyzed.

Detailed description: Patients diagnosed with hepatocellular carcinoma (HCC) undergoing elective radiofrequency (RF) ablation surgery will be randomly allocated to general anesthesia(GA) group or local anesthesia(LA) group.

Patients from GA group will receive anesthesia induced with 0.05-0.1mg/kg intravenous midazolam, 3-6ug/kg fentanyl, 1.0-2.5mg/kg propofol and 0.1-0.2mg/kg atracurium. Laryngeal mask will be used to maintain ventilation. Anesthesia will be maintained with 4-8mg/kg/h propofol and 0.1-0.3ug/kg/min remifentanil, and additional non-depolarizing muscle relaxant when necessary. In patients from LA group, analgesia will be provided by a subcutaneous injection of 2% lidocaine by the surgeons before insertion of the needles.

Serum will be collected from patients of both groups at before induction and 1h post-surgery. The HepG2 hepatic cancer cell line will be treated with patient serum from both groups. The effects of anesthetic methods on cellular invasion, migration, proliferation will be measured. The expression levels of inflammatory cytokines in the serum from patients of both groups will also be analyzed.

Eligibility criteria: Inclusion Criteria:

* 18 to 65 years old
* ASA grade I-III
* Diagnosed with a single primary liver tumor of 3cm or smaller
* Is scheduled for elective radiofrequency ablation surgery
* With no macro-vascular invasion, no lymph node or extrahepatic metastases
* Child-Pugh Class A or B

Exclusion Criteria:

* a history of liver surgery previously (including radiofrequency ablation)
* severe systemic disease (heart, lung, kidney, or immune system)
* INR\>1.5 or platelet count \<45,000 cells/mm3
* a history of addiction to opioids;
* Disagree to participate the trial

Primary outcomes:
measure: mean percentage change from post- to pre-operative values of invasion of HepG2 cells cultured in patients' serum
timeFrame: at 1 hour post-surgery
Secondary outcomes:
measure: mean percentage change from post- to pre-operative values of migration of HepG2 cells cultured in patients' serum
timeFrame: at 1 hour post-surgery
measure: mean percentage change from post- to pre-operative values of proliferation of HepG2 cells cultured in patients' serum
timeFrame: at 1 hour post-surgery
measure: serum IL-1β level
timeFrame: at 1 hour post-surgery
measure: serum IL-6 level
timeFrame: at 1 hour post-surgery
measure: serum TNF-α level
timeFrame: at 1 hour post-surgery
measure: serum IFN-gamma level
timeFrame: at 1 hour post-surgery
measure: serum IL-2 level
timeFrame: at 1 hour post-surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital affliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Jie Tian
role: PRINCIPAL_INVESTIGATOR
References: