Effects of Anesthetic Methods on Hepatic Cancer Cell Malignancy

April 3, 2020 updated by: Jie Tian, RenJi Hospital

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 1 hour post-surgery
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
Time Frame: 1 hour post-surgery
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
Time Frame: 1 hour post-surgery
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

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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