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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03594188
Other study ID # HEP201807
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 23, 2018
Est. completion date December 31, 2019

Study information

Verified date April 2020
Source RenJi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date December 31, 2019
Est. primary completion date July 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Procedure:
anesthetic methods
Patients will receive standard GA or LA for RF surgery.

Locations

Country Name City State
China Renji Hospital affliated to Shanghai Jiaotong University School of Medicine Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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