Renal Cell CarcinomaNCT04503148
Anesthesia and Cancer Study: Renal Cell Carcinoma
A study testing Propofol and Inhaled General Anesthetics in people with Renal Cell Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study investigates the influence of type of anesthesia on recurrence and survival of renal cell carcinoma in patients undergoing nephrectomy. The participants will be allocated to either the group receiving the total intravenous anesthesia (TIVA) using propofol or the group receiving the inhaled anesthetics, such… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Propofol and Inhaled General Anesthetics
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 562 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Sep 2020to 22 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients scheduled for elective nephrectomy due to renal cell carcinoma
Who cannot join
- Emergency surgery
- Pregnancy
- Allergies to anesthetics
- Palliative surgery
- Refusal to participate in the study
- History of diagnosis or surgery for other cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Type of Anesthesia on Recurrence of Renal Cell Carcinoma After Nephrectomy: a Prospective Randomized Controlled Study
This study investigates the influence of type of anesthesia on recurrence and survival of renal cell carcinoma in patients undergoing nephrectomy. The participants will be allocated to either the group receiving the total intravenous anesthesia (TIVA) using propofol or the group receiving the inhaled anesthetics, such as sevoflurane or desflurane.
Read the detailed description
The effect of anesthesia on cancer recurrence and survival is controversial. According to some retrospective studies and preclinical studies, TIVA is suggested to be more favorable than inhalation anesthesia regarding cancer recurrence and survival after surgery. However, to our knowledge, there is no study which investigates the influence of type of anesthesia on recurrence of renal cell carcinoma after nephrectomy.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Propofol, Inhaled General Anesthetics
- Keywords
- Anesthesia, Propofol, Inhaled anesthetics, Renal cell carcinoma, Nephrectomy
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Propofol 1-2 mg/kg bolus injection for induction of anesthesia propofol continuous infusion for maintenance of anesthesia
Inhaled General AnestheticsDrug
Sevoflurane or desflurane for induction and maintenance of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| TIVA group | Experimental | Patients receiving the total intravenous anesthesia using propofol Receives: Drug: Propofol |
| inhalation group | Active comparator | Patients receiving inhalation anesthesia using sevoflurane or desflurane Receives: Drug: Inhaled General Anesthetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
five year metastasis-free survival
five year metastasis-free survival
Measured: five year after surgery
Secondary outcomes (5)
one year survival
survival rate regardless of recurrence
Measured: one year after surgery
three year survival
survival rate regardless of recurrence
Measured: three year after surgery
one year metastasis-free survival
one year metastasis-free survival
Measured: one years after surgery
three year metastasis-free survival
three year metastasis-free survival
Measured: three years after surgery
five year survival
survival rate regardless of recurrence
Measured: five year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start22 Sep 2020
- Primary completion22 Dec 2022
- Study completion22 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective randomized controlled study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 562 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503148
- Sponsor's protocol ID
- Ane-Can Nx
- Status last verified
- Jul 2024
- First submitted
- 3 Aug 2020
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Type of Anesthesia on Recurrence of Renal Cell Carcinoma After Nephrectomy: a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04503148
- Acronym / sponsor ID
- Ane-Can Nx
- Conditions
- Renal Cell Carcinoma
- Keywords
- Anesthesia, Propofol, Inhaled anesthetics, Renal cell carcinoma, Nephrectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 562 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2025 (estimated)
- First posted
- 7 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.
This study investigates the influence of type of anesthesia on recurrence and survival of renal cell carcinoma in patients undergoing nephrectomy. The participants will be allocated to either the group receiving the total intravenous anesthesia (TIVA) using propofol or the group receiving the inhaled anesthetics, such as sevoflurane or desflurane.
Detailed description
The effect of anesthesia on cancer recurrence and survival is controversial. According to some retrospective studies and preclinical studies, TIVA is suggested to be more favorable than inhalation anesthesia regarding cancer recurrence and survival after surgery. However, to our knowledge, there is no study which investigates the influence of type of anesthesia on recurrence of renal cell carcinoma after nephrectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| TIVA group | Experimental | Drug: PropofolPatients receiving the total intravenous anesthesia using propofol |
| inhalation group | Active comparator | Drug: Inhaled General AnestheticsPatients receiving inhalation anesthesia using sevoflurane or desflurane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients scheduled for elective nephrectomy due to renal cell carcinoma
Key exclusion criteria (6 listed)
- Emergency surgery
- Pregnancy
- Allergies to anesthetics
- Palliative surgery
- Refusal to participate in the study
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 |
|---|---|---|
| PropofolPropofol 1-2 mg/kg bolus injection for induction of anesthesia propofol continuous infusion for maintenance of anesthesia | Drug | TIVA group |
| Inhaled General AnestheticsSevoflurane or desflurane for induction and maintenance of anesthesia | Drug | inhalation group |
Primary outcome
five year metastasis-free survival
Time frame: five year after surgery
five year metastasis-free survival
5 secondary outcomes
one year survival
Time frame: one year after surgery
three year survival
Time frame: three year after surgery
one year metastasis-free survival
Time frame: one years after surgery
three year metastasis-free survival
Time frame: three years after surgery
five year survival
Time frame: five year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No
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A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
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RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
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Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
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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?
A study testing Propofol and Inhaled General Anesthetics in people with Renal Cell Carcinoma, run by Seoul National University 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 6 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: status not confirmed, as of the sponsor's last update on 23 Jul 2024. 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?
Results are not available in the source record.
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?
five year metastasis-free survival (time frame: five year after surgery). 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 23 Jul 2024.