Effects of Anesthetic Methods on Hepatic Cancer Cell Malignancy

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

Numerous studies found that anesthetic methods can influence the recurrence of tumor and the overall survival of patients after primary cancer surgery. Radiofrequency (RF) ablation is now widely used in 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 investigated the effects of anesthetic methods on proliferation, migration and metastasis in HepG2 hepatic cancer cells in vitro.

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Procedure: anesthetic methods

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Renji Hospital affliated to Shanghai Jiaotong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients with a single primary liver tumor of 3cm or smaller, who are scheduled for RF ablation surgery

Exclusion Criteria:

• less than 18 or more than 65 years old;
• ASA Physical Status 4 or greater;
• previous surgery in liver (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;
• with known extension beyond the liver;
• Child-Pugh Class C.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: general anesthesia; Patients in this group will have RF ablation for treatment of HCC under general anesthesia.	Procedure: anesthetic methods; Patients will receive standard GA or LA for RF surgery.
Active Comparator: local anesthesia; Patients in this group will have RF ablation for treatment of HCC under local anesthesia.	Procedure: anesthetic methods; Patients will receive standard GA or LA for RF surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cell proliferation	HepG2 cells will be cultured with serum from patients undergoing RF ablation under GA or LA for 24h and cell proliferation will be measured	1 hour post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cell migration	HepG2 cells will be cultured with serum from patients undergoing RF ablation under GA or LA and cell migration will be measured	1 hour post-surgery
cell metastasis	HepG2 cells will be cultured with serum from patients undergoing RF ablation under GA or LA and cell metastasis will be measured	1 hour post-surgery

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2018
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: July 11, 2018
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (Actual): July 20, 2018

Study Record Updates

• Last Update Posted (Actual): April 6, 2020
• Last Update Submitted That Met QC Criteria: April 3, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: HEP201807

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No