Back to resultsEffects of Anesthetic Methods on Hepatic Cancer Cell Malignancy
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
anesthetic methods
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
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.
Sites / Locations
- Renji Hospital affliated to Shanghai Jiaotong University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
general anesthesia
local anesthesia
Arm Description
Patients in this group will have RF ablation for treatment of HCC under general anesthesia.
Patients in this group will have RF ablation for treatment of HCC under local anesthesia.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
cell migration
HepG2 cells will be cultured with serum from patients undergoing RF ablation under GA or LA and cell migration will be measured
cell metastasis
HepG2 cells will be cultured with serum from patients undergoing RF ablation under GA or LA and cell metastasis will be measured
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03594188
Brief Title
Effects of Anesthetic Methods on Hepatic Cancer Cell Malignancy
Official Title
Effects of Serum From Hepatocellular Carcinoma Surgery Patients Under Different Anesthetic Methods on Hepatic Cancer Cell Malignancy in Vitro
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
July 23, 2018 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
general anesthesia
Arm Type
Experimental
Arm Description
Patients in this group will have RF ablation for treatment of HCC under general anesthesia.
Arm Title
local anesthesia
Arm Type
Active Comparator
Arm Description
Patients in this group will have RF ablation for treatment of HCC under local anesthesia.
Intervention Type
Procedure
Intervention Name(s)
anesthetic methods
Intervention Description
Patients will receive standard GA or LA for RF surgery.
Primary Outcome Measure Information:
Title
cell proliferation
Description
HepG2 cells will be cultured with serum from patients undergoing RF ablation under GA or LA for 24h and cell proliferation will be measured
Time Frame
1 hour post-surgery
Secondary Outcome Measure Information:
Title
cell migration
Description
HepG2 cells will be cultured with serum from patients undergoing RF ablation under GA or LA and cell migration will be measured
Time Frame
1 hour post-surgery
Title
cell metastasis
Description
HepG2 cells will be cultured with serum from patients undergoing RF ablation under GA or LA and cell metastasis will be measured
Time Frame
1 hour post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Renji Hospital affliated to Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effects of Anesthetic Methods on Hepatic Cancer Cell Malignancy
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