Renal Cell CarcinomaNCT07326280
The Cold Ischemia Robot-assisted Partial Nephrectomy
A study testing Cold ischemia robot-assisted partial nephrectomy and Warm ischemia robot-assisted partial nephrectomy in people with Renal Cell Carcinoma and Renal Function Abnormal, run by Sun Yat-sen University at 1 site in China.
Trial summary
To establish evidence that cold ischemia, achieved through the use of ice slush, can improve the recovery from ischemia on the operated kidney in patients undergoing robot-assisted partial nephrectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Cell Carcinoma, Renal Function Abnormal
- What is being tested?
- Cold ischemia robot-assisted partial nephrectomy and Warm ischemia robot-assisted partial nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2026
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 80 years old; 2. Intending to perform robot-assisted partial nephrectomy
Who cannot join
- Anesthesiologist assessment: Patient unsuitable for general anesthesia;
- Having severe cardiovascular and cerebrovascular diseases;
- horseshoe kidney;
- pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
651 Dongfeng Road East, Yuexiu District, Guangzhou, P.R. China Sun Yat-sen University Cancer Center；
Guangzhou, Guangdong, 510000
About this study
Official title: The Impact of Cold Ischemia on Recovery From Ischemia After Robot-assisted Partial Nephrectomy: A Randomized Controlled Clinical Study
To establish evidence that cold ischemia, achieved through the use of ice slush, can improve the recovery from ischemia on the operated kidney in patients undergoing robot-assisted partial nephrectomy.
Read the detailed description
Randomly dividing the study cohorts into two groups. One group undergoing cold ischemia partial nephrectomy and the other undergoing warm ischemia partial nephrectomy. Comparing the short-term renal function recovery between the two groups.
- Conditions
- Renal Cell Carcinoma, Renal Function Abnormal
- Being tested
- Cold ischemia robot-assisted partial nephrectomy, Warm ischemia robot-assisted partial 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.
Cold ischemia robot-assisted partial nephrectomyProcedure or surgery
During the surgical procedure, employing ice to achieve local hypothermia in the kidneys.
Warm ischemia robot-assisted partial nephrectomyProcedure or surgery
Not applying local hypothermia to the kidneys during the surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| Cold ischemia | Experimental | During the surgical procedure, employing ice to achieve local hypothermia in the kidneys. Receives: Procedure: Cold ischemia robot-assisted partial nephrectomy |
| Warm ischemia | Active comparator | Not applying local hypothermia to the kidneys during the surgical procedure Receives: Procedure: Warm ischemia robot-assisted partial nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery from ischemia
(%GFR saved)/(%parenchymal mass preserved)
Measured: 1-12 months after surgery
Secondary outcomes (3)
surgical duration
The duration of the surgery
Measured: Intraoperative
surgical complications
Intraoperative and postoperative complication incidence rate
Measured: 1-12 months after surgery
The extent of decline in the long-term GFR (month13-24) on the operated kidney compared to the new baseline GFR(months 1-12).
Postoperative short-term GFR(months 1-12) minus long-term GFR(month13-24)
Measured: up to 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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 Sun Yat-sen UniversityThe 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
- Model description
- Randomly dividing the study cohorts into two groups. One group undergoing cold ischemia robot-assisted partial nephrectomy，while the other group undergoing warm ischemia robot-assisted partial nephrectomy
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZHOU FANGJIAN, Sun Yat-sen University
- Investigators
- Fangjian Zhou, professor, Principal investigator, Sun Yat-sen University Cancer Center (SYSUCC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326280
- Sponsor's protocol ID
- SL-B2022-518-03
- Status last verified
- Jan 2026
- First submitted
- 26 Nov 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Cold Ischemia on Recovery From Ischemia After Robot-assisted Partial Nephrectomy: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07326280
- Acronym / sponsor ID
- SL-B2022-518-03
- Conditions
- Renal Cell Carcinoma, Renal Function Abnormal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Jan 2026 (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.
To establish evidence that cold ischemia, achieved through the use of ice slush, can improve the recovery from ischemia on the operated kidney in patients undergoing robot-assisted partial nephrectomy.
Detailed description
Randomly dividing the study cohorts into two groups. One group undergoing cold ischemia partial nephrectomy and the other undergoing warm ischemia partial nephrectomy. Comparing the short-term renal function recovery between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomly dividing the study cohorts into two groups. One group undergoing cold ischemia robot-assisted partial nephrectomy，while the other group undergoing warm ischemia robot-assisted partial nephrectomy
| Arm | Type | Receives |
|---|---|---|
| Cold ischemia | Experimental | Procedure: Cold ischemia robot-assisted partial nephrectomyDuring the surgical procedure, employing ice to achieve local hypothermia in the kidneys. |
| Warm ischemia | Active comparator | Procedure: Warm ischemia robot-assisted partial nephrectomyNot applying local hypothermia to the kidneys during the surgical procedure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 to 80 years old; 2. Intending to perform robot-assisted partial nephrectomy
Key exclusion criteria (4 listed)
- Anesthesiologist assessment: Patient unsuitable for general anesthesia;
- Having severe cardiovascular and cerebrovascular diseases;
- horseshoe kidney;
- pregnant women
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 |
|---|---|---|
| Cold ischemia robot-assisted partial nephrectomyDuring the surgical procedure, employing ice to achieve local hypothermia in the kidneys. | Procedure or surgery | Cold ischemia |
| Warm ischemia robot-assisted partial nephrectomyNot applying local hypothermia to the kidneys during the surgical procedure | Procedure or surgery | Warm ischemia |
Primary outcome
Recovery from ischemia
Time frame: 1-12 months after surgery
(%GFR saved)/(%parenchymal mass preserved)
3 secondary outcomes
surgical duration
Time frame: Intraoperative
surgical complications
Time frame: 1-12 months after surgery
The extent of decline in the long-term GFR (month13-24) on the operated kidney compared to the new baseline GFR(months 1-12).
Time frame: up to 2 years after surgery
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 8 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Fangjian Zhou, professor principal investigator
Sun Yat-sen University Cancer Center (SYSUCC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold ischemia robot-assisted partial nephrectomy and Warm ischemia robot-assisted partial nephrectomy in people with Renal Cell Carcinoma and Renal Function Abnormal, run by Sun Yat-sen University 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 1 inclusion and 4 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 8 Jan 2026. 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?
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 Fangjian Zhou, professor (020-87343865, zhoufj@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery from ischemia (time frame: 1-12 months 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 8 Jan 2026.