Hepatocellular CarcinomaPhase 4NCT05331911
Impact of Propofol-Based Total Intravenous Anesthesia Versus Anesthesia With Sevoflurane on Long-term Outcomes With Patients Undergoing Elective Excision of Primary Liver Tumors
A Phase 4 study testing Propofol and Sevoflurane in people with Hepatocellular Carcinoma, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
This is a two-arm, parallel-group randomized clinical trial. Routine perioperative care would be performed in volunteers with primary Hepatocellular carcinoma. The study will enroll approximately 500 volunteers to compare the progression-free or overall survival in patients undergoing elective partial hepatectomy for… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Apr 2022to 31 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Twenty to eighty-year-old.
- ASA class I-III.
- Patients undergoing partial hepatectomy for hepatocellular carcinoma under general anesthesia.
Who cannot join
- Severe mental disorder
- Pregnant or lactating women
- Morbidly obese
- Allergy to any of the drugs used in this study
- Recurrent tumor or repeat surgery
- Biopsy cases
Show all 12Show fewer
- Incomplete data collection before the surgery
- Palliative treatment after surgery
- simultaneous treatment of other malignancies
- Combined propofol and inhalation anesthesia or other anesthetics, such as ketamine or dexmedetomidine
- Diagnosed as benign liver tumor
- Emergency surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
About this study
Official title: Impact of Propofol-Based Total Intravenous Anesthesia Versus Anesthesia With Sevoflurane
This is a two-arm, parallel-group randomized clinical trial. Routine perioperative care would be performed in volunteers with primary Hepatocellular carcinoma. The study will enroll approximately 500 volunteers to compare the progression-free or overall survival in patients undergoing elective partial hepatectomy for primary liver tumors between propofol and sevoflurane for the maintenance of anesthesia.
Read the detailed description
Before the scheduled procedure, the patients are randomly assigned into peopofol group or groups (1:1) according to the randomization generated by the computer. Both groups were induced with propofol 1~2.5 mg/kg propofol. The propofol group was maintained at an effect-site concentration of 2.0-4.0 mcg/mL by a target-controlled infusion system. The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC). During the operation, the dose of anesthetic drugs (propofol/fentanyl /remifentanil and sevoflurane/cisatracurium/rocuronium) are adjusted to maintain the mean arterial pressure and heartbeat fluctuations within 20% of the baseline value and Entropy (or BIS) value at 40-60in both groups. The following patient data were recorded, the type of anesthesia, sex, age at the time of surgery, preoperative Karnofsky performance status score and functional capacity, the postoperative complications within 30 days (according Clavien-Dindo classification), American Society of Anesthesiologists physical status scores, tumor size, intraoperative blood loss/transfusion, duration of surgery, duration of anesthesia, total opioid (remifentanil/fentanyl/ propofol) use, postoperative radiation therapy, postoperative chemotherapy, postoperative concurrent chemoradiotherapy, the presence of disease progression, and 6-month, 1-year, and 3-year overall survival and Karnofsky performance status score were recorded.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Propofol, Sevoflurane
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called total intravenous anesthesia
total intravenous anesthesia with propofol for the partial hepatectomy of hepatocellular carcinoma.
SevofluraneDrug
The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC).
| Study group | Role | What they receive |
|---|---|---|
| Propofol Group | Experimental | The propofol group was maintained at an effect-site concentration (Ce) of 2.0-4.0 mcg/mL by a target-controlled infusion (TCI) system. Receives: Drug: Propofol |
| Sevoflurane group | Experimental | The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC). Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
6-month overall survival, 1-year overall survival, and 3-year overall survival
Measured: From the date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months"
The presence of disease progression
From the date of surgery until the date of first documented progression (recurrence or metastasis) or date of death from any cause, assessed up to 36 months"
Measured: From the date of surgery until the date of first documented progression (recurrence or metastasis),assessed up to 36 months
Secondary outcomes (3)
Postoperative complications
Clavien-Dindo classification, and other postoperative complications
Measured: The period from the day of surgery to postoperative 30 days
Karnofsky performance status score
to access patients' functional impairment
Measured: Karnofsky performance score(from 0 (dead) to 100(normal no complication)) before surgery (baseline data) , postoperation 7 days, postoperation 3 months, postoperation 6 months, postoperation 12 months
Length of hospital stays
the length of stays in general ward and ICU
Measured: from the day of surgery to dischage, assessed up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start26 Apr 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
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 Kaohsiung Medical University Chung-Ho Memorial 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Tri-Service General Hospital (TSGH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331911
- Sponsor's protocol ID
- KMUHIRB-F(I)-20220034
- Status last verified
- Mar 2022
- First submitted
- 29 Mar 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: depends the various challenges in this study.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Propofol-Based Total Intravenous Anesthesia Versus Anesthesia With Sevoflurane
- ClinicalTrials.gov ID
- NCT05331911
- Acronym / sponsor ID
- KMUHIRB-F(I)-20220034
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Collaborators
- Tri-Service General Hospital (TSGH)
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 18 Apr 2022 (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.
This is a two-arm, parallel-group randomized clinical trial. Routine perioperative care would be performed in volunteers with primary Hepatocellular carcinoma. The study will enroll approximately 500 volunteers to compare the progression-free or overall survival in patients undergoing elective partial hepatectomy for primary liver tumors between propofol and sevoflurane for the maintenance of anesthesia.
Detailed description
Before the scheduled procedure, the patients are randomly assigned into peopofol group or groups (1:1) according to the randomization generated by the computer. Both groups were induced with propofol 1~2.5 mg/kg propofol. The propofol group was maintained at an effect-site concentration of 2.0-4.0 mcg/mL by a target-controlled infusion system. The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC). During the operation, the dose of anesthetic drugs (propofol/fentanyl /remifentanil and sevoflurane/cisatracurium/rocuronium) are adjusted to maintain the mean arterial pressure and heartbeat fluctuations within 20% of the baseline value and Entropy (or BIS) value at 40-60in both groups. The following patient data were recorded, the type of anesthesia, sex, age at the time of surgery, preoperative Karnofsky performance status score and functional capacity, the postoperative complications within 30 days (according Clavien-Dindo classification), American Society of Anesthesiologists physical status scores, tumor size, intraoperative blood loss/transfusion, duration of surgery, duration of anesthesia, total opioid (remifentanil/fentanyl/ propofol) use, postoperative radiation therapy, postoperative chemotherapy, postoperative concurrent chemoradiotherapy, the presence of disease progression, and 6-month, 1-year, and 3-year overall survival and Karnofsky performance status score were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol Group | Experimental | Drug: PropofolThe propofol group was maintained at an effect-site concentration (Ce) of 2.0-4.0 mcg/mL by a target-controlled infusion (TCI) system. |
| Sevoflurane group | Experimental | Drug: SevofluraneThe sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC). |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Twenty to eighty-year-old.
- ASA class I-III.
- Patients undergoing partial hepatectomy for hepatocellular carcinoma under general anesthesia.
Key exclusion criteria (12 listed)
- Severe mental disorder
- Pregnant or lactating women
- Morbidly obese
- Allergy to any of the drugs used in this study
- Recurrent tumor or repeat 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 |
|---|---|---|
| PropofolAlso: total intravenous anesthesiatotal intravenous anesthesia with propofol for the partial hepatectomy of hepatocellular carcinoma. | Drug | Propofol Group |
| SevofluraneThe sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC). | Drug | Sevoflurane group |
Primary outcome
Overall survival
Time frame: From the date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months"
6-month overall survival, 1-year overall survival, and 3-year overall survival
The presence of disease progression
Time frame: From the date of surgery until the date of first documented progression (recurrence or metastasis),assessed up to 36 months
From the date of surgery until the date of first documented progression (recurrence or metastasis) or date of death from any cause, assessed up to 36 months"
3 secondary outcomes
Postoperative complications
Time frame: The period from the day of surgery to postoperative 30 days
Karnofsky performance status score
Time frame: Karnofsky performance score(from 0 (dead) to 100(normal no complication)) before surgery (baseline data) , postoperation 7 days, postoperation 3 months, postoperation 6 months, postoperation 12 months
Length of hospital stays
Time frame: from the day of surgery to dischage, assessed up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Individual participant dataSharing planned: Undecided. depends the various challenges in this study.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol and Sevoflurane in people with Hepatocellular Carcinoma, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 30 Nov 2022. 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 Taiwan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guan-Yu Chen, M.D. (07-3121101 ext. 7035, kindtaco@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: From the date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months"). The study lists 2 primary outcomes in all. 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 30 Nov 2022.