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NCT Number: NCT04510935

Effects of Anesthetic Methods on Hepatic Cancer Cell Function in Vitro

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Renji Hospital affliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

General Anesthesia

Procedure

the patient will receive general anesthesia during surgery in this group.

local anesthesia

Procedure

the patient will receive local anesthesia during surgery in this group.

Primary outcomes

  1. mean percentage change from post- to pre-operative values of invasion of HepG2 cells cultured in patients' serum

    Time frame: at 1 hour post-surgery

    HepG2 cells will be cultured with serum from patients undergoing RF ablation under GA or LA for 24h. Cell invasion will be measured with Matrigel methods. Mean percentage change from post- to pre-operative values of invasion for each individual patient will be calculated and compared between the GA and LA groups.

Secondary outcomes

  1. mean percentage change from post- to pre-operative values of migration of HepG2 cells cultured in patients' serum

    Time frame: at 1 hour post-surgery

    HepG2 cells will be cultured with serum from patients undergoing RF ablation under GA or LA for 24h. Cell migration will be measured with Transwell methods. Mean percentage change from post- to pre-operative values of migration for each individual patient will be calculated and compared between the GA and LA groups.

  2. mean percentage change from post- to pre-operative values of proliferation of HepG2 cells cultured in patients' serum

    Time frame: at 1 hour post-surgery

    HepG2 cells will be cultured with serum from patients undergoing RF ablation under GA or LA for 24h. Cell proliferation will be measured with EdU methods. Mean percentage change from post- to pre-operative values of proliferation for each individual patient will be calculated and compared between the GA and LA groups.

  3. serum IL-1β level

    Time frame: at 1 hour post-surgery

    an inflammatory mediator that reflects systemic inflammation

  4. serum IL-6 level

    Time frame: at 1 hour post-surgery

    an inflammatory mediator that reflects systemic inflammation

  5. serum TNF-α level

    Time frame: at 1 hour post-surgery

    an inflammatory mediator that reflects systemic inflammation

  6. serum IFN-gamma level

    Time frame: at 1 hour post-surgery

    an inflammatory mediator that reflects systemic inflammation

  7. serum IL-2 level

    Time frame: at 1 hour post-surgery

    an inflammatory mediator that reflects systemic inflammation

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

Effects of Serum From Hepatocellular Carcinoma Surgery Patients Under Different Anesthetic Methods on Hepatic Cancer Cell Function in Vitro

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 12, 2020
Registry last updated
Jan 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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