Effects of Anesthetic Methods on Hepatic Cancer Cell Malignancy

NCT03594188 | Completed

• 1 other identifier: HEP201807
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• cell migration

  1 hour post-surgery

• cell metastasis

  1 hour post-surgery

Study Arms (2)

general anesthesia

EXPERIMENTAL

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

Procedure: anesthetic methods

local anesthesia

ACTIVE COMPARATOR

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

Procedure: anesthetic methods

Interventions

anesthetic methods PROCEDURE

Patients will receive standard GA or LA for RF surgery.

general anesthesia; local anesthesia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital affliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: July 20, 2018
• Study Start: July 23, 2018
• Primary Completion: July 31, 2019
• Study Completion: December 31, 2019
• Last Updated: April 6, 2020

Record last verified: 2020-04

Locations

CN (1)