Hepatocellular CarcinomaNCT04510935
Effects of Anesthetic Methods on Hepatic Cancer Cell Function in Vitro
A study testing general anesthesia and local anesthesia in people with Hepatocellular Carcinoma, run by RenJi Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- general anesthesia and local anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2020to 28 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital affliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200127
About this study
Official title: Effects of Serum From Hepatocellular Carcinoma Surgery Patients Under Different Anesthetic Methods on Hepatic Cancer Cell Function in Vitro
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.
Read the detailed description
Patients diagnosed with hepatocellular carcinoma (HCC) undergoing elective radiofrequency (RF) ablation surgery will be randomly allocated to general anesthesia(GA) group or local anesthesia(LA) group.
Patients from GA group will receive anesthesia induced with 0.05-0.1mg/kg intravenous midazolam, 3-6ug/kg fentanyl, 1.0-2.5mg/kg propofol and 0.1-0.2mg/kg atracurium. Laryngeal mask will be used to maintain ventilation. Anesthesia will be maintained with 4-8mg/kg/h propofol and 0.1-0.3ug/kg/min remifentanil, and additional non-depolarizing muscle relaxant when necessary. In patients from LA group, analgesia will be provided by a subcutaneous injection of 2% lidocaine by the surgeons before insertion of the needles.
Serum will be collected from patients of both groups at before induction and 1h post-surgery. The HepG2 hepatic cancer cell line will be treated with patient serum from both groups. The effects of anesthetic methods on cellular invasion, migration, proliferation will be measured. The expression levels of inflammatory cytokines in the serum from patients of both groups will also be analyzed.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- general anesthesia, local anesthesia
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general anesthesiaProcedure or surgery
the patient will receive general anesthesia during surgery in this group.
local anesthesiaProcedure or surgery
the patient will receive local anesthesia during surgery in this group.
| Study group | Role | What they receive |
|---|---|---|
| general anesthesia | Experimental | Patients in this group will have RF ablation for treatment of HCC under general anesthesia. Receives: Procedure: general anesthesia |
| local anesthesia | Active comparator | In this group, patients will receive radiofrequency ablation under local anesthesia. Receives: Procedure: local anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
HepG2 cells will be cultured with serum from patients undergoing RF ablation under GA or LA for 24h. Cell migration will be measured with Transwell methods. Mean percentage change from post- to pre-operative values of migration for each individual patient will be calculated and compared between the GA and LA groups.
Measured: at 1 hour post-surgery
mean percentage change from post- to pre-operative values of proliferation 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 proliferation will be measured with EdU methods. Mean percentage change from post- to pre-operative values of proliferation for each individual patient will be calculated and compared between the GA and LA groups.
Measured: at 1 hour post-surgery
serum IL-1β level
an inflammatory mediator that reflects systemic inflammation
Measured: at 1 hour post-surgery
serum IL-6 level
an inflammatory mediator that reflects systemic inflammation
Measured: at 1 hour post-surgery
serum TNF-α level
an inflammatory mediator that reflects systemic inflammation
Measured: at 1 hour post-surgery
serum IFN-gamma level
an inflammatory mediator that reflects systemic inflammation
Measured: at 1 hour post-surgery
serum IL-2 level
an inflammatory mediator that reflects systemic inflammation
Measured: at 1 hour post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start20 Aug 2020
- Primary completion30 Nov 2020
- Study completion28 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Tian, RenJi Hospital
- Investigators
- Jie Tian, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510935
- Sponsor's protocol ID
- HCCRA202008
- Status last verified
- Jan 2021
- First submitted
- 9 Aug 2020
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nunez-Rodriguez E, Zhang H, Sah D, Cata JP. Intersection Between Local Anesthetics and Cancer Biology: What Now? Where Are We Going? Adv Biol (Weinh). 2025 Oct;9(10):e00122. doi: 10.1002/adbi.202500122. Epub 2025 Aug 7.
PubMed 40772525
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Serum From Hepatocellular Carcinoma Surgery Patients Under Different Anesthetic Methods on Hepatic Cancer Cell Function in Vitro
- ClinicalTrials.gov ID
- NCT04510935
- Acronym / sponsor ID
- HCCRA202008
- Conditions
- Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 28 Dec 2020 (actual)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients diagnosed with hepatocellular carcinoma (HCC) undergoing elective radiofrequency (RF) ablation surgery will be randomly allocated to general anesthesia(GA) group or local anesthesia(LA) group.
Patients from GA group will receive anesthesia induced with 0.05-0.1mg/kg intravenous midazolam, 3-6ug/kg fentanyl, 1.0-2.5mg/kg propofol and 0.1-0.2mg/kg atracurium. Laryngeal mask will be used to maintain ventilation. Anesthesia will be maintained with 4-8mg/kg/h propofol and 0.1-0.3ug/kg/min remifentanil, and additional non-depolarizing muscle relaxant when necessary. In patients from LA group, analgesia will be provided by a subcutaneous injection of 2% lidocaine by the surgeons before insertion of the needles.
Serum will be collected from patients of both groups at before induction and 1h post-surgery. The HepG2 hepatic cancer cell line will be treated with patient serum from both groups. The effects of anesthetic methods on cellular invasion, migration, proliferation will be measured. The expression levels of inflammatory cytokines in the serum from patients of both groups will also be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| general anesthesia | Experimental | Procedure: general anesthesiaPatients in this group will have RF ablation for treatment of HCC under general anesthesia. |
| local anesthesia | Active comparator | Procedure: local anesthesiaIn this group, patients will receive radiofrequency ablation under local anesthesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| general anesthesiathe patient will receive general anesthesia during surgery in this group. | Procedure or surgery | general anesthesia |
| local anesthesiathe patient will receive local anesthesia during surgery in this group. | Procedure or surgery | local anesthesia |
Primary outcome
mean percentage change from post- to pre-operative values of invasion of HepG2 cells cultured in patients' serum
Time frame: at 1 hour post-surgery
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.
7 secondary outcomes
mean percentage change from post- to pre-operative values of migration of HepG2 cells cultured in patients' serum
Time frame: at 1 hour post-surgery
mean percentage change from post- to pre-operative values of proliferation of HepG2 cells cultured in patients' serum
Time frame: at 1 hour post-surgery
serum IL-1β level
Time frame: at 1 hour post-surgery
serum IL-6 level
Time frame: at 1 hour post-surgery
serum TNF-α level
Time frame: at 1 hour post-surgery
serum IFN-gamma level
Time frame: at 1 hour post-surgery
serum IL-2 level
Time frame: at 1 hour post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Derived from this study: PubMed 40772525Nunez-Rodriguez E, Zhang H, Sah D, Cata JP. Intersection Between Local Anesthetics and Cancer Biology: What Now? Where Are We Going? Adv Biol (Weinh). 2025 Oct;9(10):e00122. doi: 10.1002/adbi.202500122. Epub 2025 Aug 7.
- Individual participant dataSharing planned: Undecided
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Tian principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing general anesthesia and local anesthesia in people with Hepatocellular Carcinoma, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean percentage change from post- to pre-operative values of invasion of HepG2 cells cultured in patients' serum (time frame: at 1 hour post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04510935, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2021.