RCC, Renal Cell CancerNCT06908902
Prospective Study on the Safety and Efficacy of Robot-Assisted Laparoscopic Partial Nephrectomy With Renal Artery Off-Clamp in the Treatment of cT1 Renal Tumors
A study testing partial nephrectomy with main or branch renal artery clamping and partial nephrectomy with zero renal artery clamping in people with RCC, Renal Cell Cancer and Partial Nephrectomy, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Renal tumors are common urological cancers, with over 430,000 new cases and more than 170,000 deaths globally in 2020. In China, renal cancer ranks third among urological malignancies, with an increasing incidence. Risk factors include smoking, obesity, hypertension, and family history. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- RCC, Renal Cell Cancer, Partial Nephrectomy
- What is being tested?
- partial nephrectomy with main or branch renal artery clamping and partial nephrectomy with zero renal artery clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 31 Dec 2027
- 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
- Imaging examination confirms a T1 renal tumor (including T1a and T1b), and the investigator deems partial nephrectomy to be beneficial.
- Age ranges from 18 to 90 years.
- No history of severe kidney disease or autoimmune disorders.
- Cardiopulmonary function indicates the ability to tolerate major abdominal surgery.
- ECOG performance status score is 0 or 1.
- Willingness to undergo zero-ischemia partial nephrectomy and able to provide written informed consent, understanding and agreeing to comply with the study requirements and evaluation schedule.
Who cannot join
- Imaging assessment shows a tumor stage of ≥T2.
- Imaging indicates that the tumor is located in the renal pelvis or is a Wilms' tumor, etc.
- The investigator considers the patient unsuitable for partial nephrectomy.
- Major surgery or significant trauma occurred within 28 days prior to enrollment.
- Live vaccine received within 28 days prior to enrollment.
- Severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral treatment occurred within 14 days prior to enrollment.
- Any traditional Chinese medicine or herbal supplements for cancer treatment taken within 14 days prior to enrollment.
- Participation in any other clinical trials.
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
The first affiliated hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
Qiang Lu, PhD, 13505196501, doctorlvqiang@njmu.edu.cn
Xiao Yang, +86 13951813528, yangxiao2915@163.com
About this study
Renal tumors are common urological cancers, with over 430,000 new cases and more than 170,000 deaths globally in 2020. In China, renal cancer ranks third among urological malignancies, with an increasing incidence. Risk factors include smoking, obesity, hypertension, and family history. Surgery, including partial nephrectomy and radical nephrectomy, is the primary treatment. According to AJCC staging, tumors ≤7 cm confined to the kidney are classified as T1 stage. Studies show no significant difference in cancer-specific survival between partial nephrectomy and radical nephrectomy for T1 tumors, and partial nephrectomy preserves renal function, reducing the risk of metabolic and cardiovascular diseases. Therefore, European guidelines recommend partial nephrectomy for cT1a-b tumors.
Partial nephrectomy can be performed via open surgery, laparoscopy, or robotic assistance, each with pros and cons. Robotic or laparoscopic approaches have less blood loss and shorter hospital stays compared to open surgery. A 7-year follow-up shows no significant difference in oncological outcomes. The surgical goal is to remove the tumor with negative margins while preserving normal renal tissue. Factors such as preoperative renal function, ischemia time, extent of normal tissue resection, blood loss, and suturing technique affect postoperative renal function.
Read more
Renal artery clamping is often required during partial nephrectomy to improve visibility, but it leads to ischemia-reperfusion injury, so minimizing damage is crucial. Controlling warm ischemia time is an effective strategy, with guidelines recommending ischemia time under 30 minutes. Studies show that continuous or knotless suturing techniques reduce ischemia time and blood loss. Additionally, minimizing the ischemic area helps protect renal function. Our center explored branch renal artery clamping, which, although increasing ischemia time, better protects kidney function. A study showed a smaller decline in glomerular filtration rate (GFR) with branch clamping compared to conventional clamping.
Gill et al. reported a "zero-ischemia" technique using controlled hypotension and selective clamping of higher-level renal artery branches, showing no significant change in serum creatinine or GFR. However, both renal artery clamping techniques cause ischemia-reperfusion injury, affecting renal function. A study of robotic-assisted partial nephrectomy found that 20.2% of patients had worsened chronic kidney disease (CKD) staging, with statistically significant differences in preoperative and postoperative GFR and CKD staging.
For patients with solitary or functionally solitary kidneys, or those with comorbidities like hypertension or diabetes, renal artery clamping may worsen acute renal dysfunction and increase the risk of long-term kidney failure. Avoiding renal artery clamping may reduce ischemia-reperfusion injury, but its safety and efficacy remain unclear.
A retrospective study of 537 solitary kidney patients undergoing open surgery with different vascular management strategies (no clamping, warm ischemia, and cold ischemia) showed that the risk of renal failure was lower in patients without ischemia. While this study focused on open surgery, it raises the question of whether zero-ischemia partial nephrectomy is feasible in minimally invasive surgery. A study on 141 renal angiomyolipoma patients using a zero-ischemia technique showed no significant change in GFR. However, this method may not be suitable for malignant tumors.
the investigators aims to evaluate whether robotic-assisted laparoscopic partial nephrectomy using a zero-ischemia technique for cT1 renal tumors can better protect renal function, reduce postoperative complications, and not affect oncological outcomes.
- Conditions
- RCC, Renal Cell Cancer, Partial Nephrectomy
- Being tested
- partial nephrectomy with main or branch renal artery clamping, partial nephrectomy with zero renal artery clamping
- 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.
partial nephrectomy with main or branch renal artery clampingProcedure or surgery
Robotic-assisted laparoscopic or laparoscopic partial nephrectomy with main or branch renal artery clamping
partial nephrectomy with zero renal artery clampingProcedure or surgery
Robotic-assisted laparoscopic partial nephrectomy with zero renal artery clamping
| Study group | Role | What they receive |
|---|---|---|
| renal artery block-off set | Experimental | Not described Receives: Procedure: partial nephrectomy with zero renal artery clamping |
| renal artery block set | Active comparator | Not described Receives: Procedure: partial nephrectomy with main or branch renal artery clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum creatinine
Measured: Preoperative serum creatinine and Serum creatinine at 3 days postoperative;
Secondary outcomes (2)
Recurrence-Free Survival(RFS)
Measured: From enrollment to 3 years post-treatment completion
Glomerular Filtration Rate(GFR)
Measured: GFR before the surgery and GFR at 1 month, 3 months, and 12 months postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start1 Dec 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RCC, Renal Cell CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908902
- Sponsor's protocol ID
- 2024-sr-972
- Status last verified
- Apr 2025
- First submitted
- 11 Dec 2024
- Last updated
- 3 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on the Safety and Efficacy of Robot-Assisted Laparoscopic Partial Nephrectomy With Renal Artery Off-Clamp in the Treatment of cT1 Renal Tumors
- ClinicalTrials.gov ID
- NCT06908902
- Acronym / sponsor ID
- 2024-sr-972
- Conditions
- RCC, Renal Cell Cancer, Partial Nephrectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Apr 2025 (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.
Renal tumors are common urological cancers, with over 430,000 new cases and more than 170,000 deaths globally in 2020. In China, renal cancer ranks third among urological malignancies, with an increasing incidence. Risk factors include smoking, obesity, hypertension, and family history. Surgery, including partial nephrectomy and radical nephrectomy, is the primary treatment. According to AJCC staging, tumors ≤7 cm confined to the kidney are classified as T1 stage. Studies show no significant difference in cancer-specific survival between partial nephrectomy and radical nephrectomy for T1 tumors, and partial nephrectomy preserves renal function, reducing the risk of metabolic and cardiovascular diseases. Therefore, European guidelines recommend partial nephrectomy for cT1a-b tumors.
Partial nephrectomy can be performed via open surgery, laparoscopy, or robotic assistance, each with pros and cons. Robotic or laparoscopic approaches have less blood loss and shorter hospital stays compared to open surgery. A 7-year follow-up shows no significant difference in oncological outcomes. The surgical goal is to remove the tumor with negative margins while preserving normal renal tissue. Factors such as preoperative renal function, ischemia time, extent of normal tissue resection, blood loss, and suturing technique affect postoperative renal function.
Renal artery clamping is often required during partial nephrectomy to improve visibility, but it leads to ischemia-reperfusion injury, so minimizing damage is crucial. Controlling warm ischemia time is an effective strategy, with guidelines recommending ischemia time under 30 minutes. Studies show that continuous or knotless suturing techniques reduce ischemia time and blood loss. Additionally, minimizing the ischemic area helps protect renal function. Our center explored branch renal artery clamping, which, although increasing ischemia time, better protects kidney function. A study showed a smaller decline in glomerular filtration rate (GFR) with branch clamping compared to conventional clamping.
Gill et al. reported a "zero-ischemia" technique using controlled hypotension and selective clamping of higher-level renal artery branches, showing no significant change in serum creatinine or GFR. However, both renal artery clamping techniques cause ischemia-reperfusion injury, affecting renal function. A study of robotic-assisted partial nephrectomy found that 20.2% of patients had worsened chronic kidney disease (CKD) staging, with statistically significant differences in preoperative and postoperative GFR and CKD staging.
For patients with solitary or functionally solitary kidneys, or those with comorbidities like hypertension or diabetes, renal artery clamping may worsen acute renal dysfunction and increase the risk of long-term kidney failure. Avoiding renal artery clamping may reduce ischemia-reperfusion injury, but its safety and efficacy remain unclear.
A retrospective study of 537 solitary kidney patients undergoing open surgery with different vascular management strategies (no clamping, warm ischemia, and cold ischemia) showed that the risk of renal failure was lower in patients without ischemia. While this study focused on open surgery, it raises the question of whether zero-ischemia partial nephrectomy is feasible in minimally invasive surgery. A study on 141 renal angiomyolipoma patients using a zero-ischemia technique showed no significant change in GFR. However, this method may not be suitable for malignant tumors.
the investigators aims to evaluate whether robotic-assisted laparoscopic partial nephrectomy using a zero-ischemia technique for cT1 renal tumors can better protect renal function, reduce postoperative complications, and not affect oncological outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| renal artery block-off set | Experimental | Procedure: partial nephrectomy with zero renal artery clamping |
| renal artery block set | Active comparator | Procedure: partial nephrectomy with main or branch renal artery clamping |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Imaging examination confirms a T1 renal tumor (including T1a and T1b), and the investigator deems partial nephrectomy to be beneficial.
- Age ranges from 18 to 90 years.
- No history of severe kidney disease or autoimmune disorders.
- Cardiopulmonary function indicates the ability to tolerate major abdominal surgery.
- ECOG performance status score is 0 or 1.
Key exclusion criteria (8 listed)
- Imaging assessment shows a tumor stage of ≥T2.
- Imaging indicates that the tumor is located in the renal pelvis or is a Wilms' tumor, etc.
- The investigator considers the patient unsuitable for partial nephrectomy.
- Major surgery or significant trauma occurred within 28 days prior to enrollment.
- Live vaccine received within 28 days prior to enrollment.
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 |
|---|---|---|
| partial nephrectomy with main or branch renal artery clampingRobotic-assisted laparoscopic or laparoscopic partial nephrectomy with main or branch renal artery clamping | Procedure or surgery | renal artery block set |
| partial nephrectomy with zero renal artery clampingRobotic-assisted laparoscopic partial nephrectomy with zero renal artery clamping | Procedure or surgery | renal artery block-off set |
Primary outcome
serum creatinine
Time frame: Preoperative serum creatinine and Serum creatinine at 3 days postoperative;
2 secondary outcomes
Recurrence-Free Survival(RFS)
Time frame: From enrollment to 3 years post-treatment completion
Glomerular Filtration Rate(GFR)
Time frame: GFR before the surgery and GFR at 1 month, 3 months, and 12 months postoperative.
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 3 Apr 2025.
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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 study testing partial nephrectomy with main or branch renal artery clamping and partial nephrectomy with zero renal artery clamping in people with RCC, Renal Cell Cancer and Partial Nephrectomy, run by The First Affiliated Hospital with Nanjing Medical 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 6 inclusion and 8 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 3 Apr 2025. 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 Xiao Yang, PhD (+8613951813528, yangxiao2915@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum creatinine (time frame: Preoperative serum creatinine and Serum creatinine at 3 days postoperative;). 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 3 Apr 2025.