Effects of Anesthetic Methods on Hepatic Cancer Cell Function in Vitro

Sponsor
RenJi Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04510935
Collaborator
(none)
35
1
2
4.3
8.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: general anesthesia
  • Procedure: local anesthesia
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Serum From Hepatocellular Carcinoma Surgery Patients Under Different Anesthetic Methods on Hepatic Cancer Cell Function in Vitro
Actual Study Start Date :
Aug 20, 2020
Actual Primary Completion Date :
Nov 30, 2020
Actual Study Completion Date :
Dec 28, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: general anesthesia

Patients in this group will have RF ablation for treatment of HCC under general anesthesia.

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

Active Comparator: local anesthesia

In this group, patients will receive radiofrequency ablation under local anesthesia.

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

Outcome Measures

Primary Outcome Measures

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

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

    an inflammatory mediator that reflects systemic inflammation

  4. serum IL-6 level [at 1 hour post-surgery]

    an inflammatory mediator that reflects systemic inflammation

  5. serum TNF-α level [at 1 hour post-surgery]

    an inflammatory mediator that reflects systemic inflammation

  6. serum IFN-gamma level [at 1 hour post-surgery]

    an inflammatory mediator that reflects systemic inflammation

  7. serum IL-2 level [at 1 hour post-surgery]

    an inflammatory mediator that reflects systemic inflammation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Renji Hospital affliated to Shanghai Jiaotong University School of Medicine Shanghai Shanghai China 200127

Sponsors and Collaborators

  • RenJi Hospital

Investigators

  • Principal Investigator: Jie Tian, RenJi Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jie Tian, Principle Investigator, RenJi Hospital
ClinicalTrials.gov Identifier:
NCT04510935
Other Study ID Numbers:
  • HCCRA202008
First Posted:
Aug 12, 2020
Last Update Posted:
Jan 8, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 8, 2021