Effects of Anesthetic Methods on Hepatic Cancer Cell Function in Vitro

NCT04510935 | Completed

• 1 other identifier: HCCRA202008
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Numerous studies find that anesthetic methods may influence the recurrence of tumor and the overall survival of patients after primary cancer surgery. Radiofrequency (RF) ablation is now widely used in the 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 will investigate the effects of anesthetic methods on cellular invasion, migration and proliferation of HepG2 hepatic cancer cells in vitro. The expression levels of inflammatory cytokines in the serum from patients of both groups will also be analyzed.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• mean percentage change from post- to pre-operative values of invasion of HepG2 cells cultured in patients' serum

  HepG2 cells will be cultured with serum from patients undergoing RF ablation under GA or LA for 24h. Cell invasion will be measured with Matrigel methods. Mean percentage change from post- to pre-operative values of invasion for each individual patient will be calculated and compared between the GA and LA groups.

  at 1 hour post-surgery

Secondary Outcomes (7)

• mean percentage change from post- to pre-operative values of migration of HepG2 cells cultured in patients' serum

  at 1 hour post-surgery

• mean percentage change from post- to pre-operative values of proliferation of HepG2 cells cultured in patients' serum

  at 1 hour post-surgery

• serum IL-1β level

  at 1 hour post-surgery

• serum IL-6 level

  at 1 hour post-surgery

• serum TNF-α level

  at 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: general anesthesia

local anesthesia

ACTIVE COMPARATOR

In this group, patients will receive radiofrequency ablation under local anesthesia.

Procedure: local anesthesia

Interventions

general anesthesia PROCEDURE

the patient will receive general anesthesia during surgery in this group.

general anesthesia

local anesthesia PROCEDURE

the patient will receive local anesthesia during surgery in this group.

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:

• to 65 years old
• ASA grade I-III
• Diagnosed with a single primary liver tumor of 3cm or smaller
• Is scheduled for elective radiofrequency ablation surgery
• With no macro-vascular invasion, no lymph node or extrahepatic metastases
• Child-Pugh Class A or B

You may not qualify if:

• a history of liver surgery previously (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;
• Disagree to participate the trial

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

Interventions

Anesthesia, General; Anesthesia, Local

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

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Anesthesia, Conduction

Study Officials

• Jie Tian

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

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: Principle Investigator

Study Record Dates

• First Submitted: August 9, 2020
• First Posted: August 12, 2020
• Study Start: August 20, 2020
• Primary Completion: November 30, 2020
• Study Completion: December 28, 2020
• Last Updated: January 8, 2021

Record last verified: 2021-01

Locations

CN (1)