Hepatocellular CarcinomaNCT02643173
Hepatocellular Carcinoma Recurrence and Anesthesia
An observational study of Hepatocellular Carcinoma, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The investigators will verify the prognosis of hepatocellular carcinoma (HCC) according to the main anesthetic agents used for the general anesthesia. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Volatile anesthetics and Intravenous anesthetics
- Type of treatment
- Injection or infusion
- How many people
- 259 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2015to Jun 2019
- Phase
- Observational
- 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 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing surgery due to the HCC.
Who may be able to join
- Patients undergoing surgery due to the HCC.
Who cannot join
- Patients undergoing re-operation due to the HCC.
- Patients presenting distant metastasis.
- Patients undergoing liver transplantation surgery.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
The investigators will verify the prognosis of hepatocellular carcinoma (HCC) according to the main anesthetic agents used for the general anesthesia.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Volatile anesthetics, Intravenous anesthetics
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volatile anestheticsOther
Intravenous anestheticsOther
| Study group | Role | What they receive |
|---|---|---|
| Volatile | The investigators retrospectively reviewed and analyzed the electrical medical records of patients who underwent surgery for HCC under the general anesthesia using volatile anesthetics as maintenance agents. Receives: Other: Volatile anesthetics | |
| Intravenous | The investigators retrospectively reviewed and analyzed the electrical medical records of patients who underwent surgery for HCC under the general anesthesia using intravenous anesthetics as maintenance agents. Receives: Other: Intravenous anesthetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of HCC
Measured: Postoperative 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Seok Na, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643173
- Sponsor's protocol ID
- HCC recurrence
- Status last verified
- Nov 2019
- First submitted
- 29 Dec 2015
- Last updated
- 22 Nov 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatocellular Carcinoma Recurrence and Anesthesia
- ClinicalTrials.gov ID
- NCT02643173
- Acronym / sponsor ID
- HCC recurrence
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 31 Dec 2015 (estimated)
- 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.
The investigators will verify the prognosis of hepatocellular carcinoma (HCC) according to the main anesthetic agents used for the general anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volatile | – | Other: Volatile anestheticsThe investigators retrospectively reviewed and analyzed the electrical medical records of patients who underwent surgery for HCC under the general anesthesia using volatile anesthetics as maintenance agents. |
| Intravenous | – | Other: Intravenous anestheticsThe investigators retrospectively reviewed and analyzed the electrical medical records of patients who underwent surgery for HCC under the general anesthesia using intravenous anesthetics as maintenance agents. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgery due to the HCC.
Key inclusion criteria (1 listed)
- Patients undergoing surgery due to the HCC.
Key exclusion criteria (3 listed)
- Patients undergoing re-operation due to the HCC.
- Patients presenting distant metastasis.
- Patients undergoing liver transplantation surgery.
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 |
|---|---|---|
| Volatile anesthetics | Other | Volatile |
| Intravenous anesthetics | Other | Intravenous |
Primary outcome
Recurrence of HCC
Time frame: Postoperative 2 year
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 22 Nov 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 1 inclusion and 3 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 22 Nov 2019. 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 South Korea. 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?
Recurrence of HCC (time frame: Postoperative 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2019.