Kidney CancerNCT06846112
Randomized Clinical Trial Aimed at Comparing Unclamped Robotic Partial Nephrectomy With or Without Renorrhaphy
A study testing Robotic partial nephrectomy in people with Kidney Cancer, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial summary
Intended to minimize ischemia during robotic partial nephrectomy (RPN) procedures "by any means possible". Before starting enucleation, the boundaries of the tumor are marked during SL-ocRPN surgery cautery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- Robotic partial nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jul 2023to 7 Jul 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years;
- radiological diagnosis of organ-confined renal neoplasm (cT1-2 cN0);
- patient who is a candidate, due to personal or tumor characteristics, for ocRPN intervention;
- compliant patient, able to follow the procedures/follow-up;
- patient who agrees to participate in the clinical study and the planned randomization, by signing the informed consent.
Who cannot join
- preoperative evidence of unilateral/bilateral synchronous renal neoplasms;
- personal history of renal surgery for benign or malignant pathology.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial Aimed at Comparing Unclamped Robotic Partial Nephrectomy With or Without Renorrhaphy. Randomized Control Trial Comparing Off-clamp Robotic Partial Nephrectomy With or Without Renorrhaphy. Project: GR-2021-12373396
Intended to minimize ischemia during robotic partial nephrectomy (RPN) procedures "by any means possible".
Before starting enucleation, the boundaries of the tumor are marked during SL-ocRPN surgery cautery. Once the tumor is removed, the resection bed is cauterized by dispensing monopolar energy with "quasi-contact" mode, and hemostasis is progressively improved.
Read the detailed description
Since RR impacts postoperative renal function, we believe the use of cautery instead of suture of the parenchymal breach after tumor enucleation provides at least postoperative functional results not lower, shorten the intervention time and reduce the direct costs associated with the procedure.
Based on available pilot studies, SL-ocRPN is safe, fast, and both the transfusion rate and duration of the hospital stay are not affected by the lack of renorrhaphy at the end of the enucleation. At the same time, this surgical approach does not require the use of a robotic needle holder and this can result in a reduction of direct costs related to treatment.
Furthermore, based on the preliminary data available, the rate of positive surgical margins would also not result influenced by the absence of RR and the risk of local recurrence could even be reduced by the extended one coagulation of the tumor bed after enucleation.
- Conditions
- Kidney Cancer
- Being tested
- Robotic partial nephrectomy
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic partial nephrectomyProcedure or surgery
Robotic partial nephrectomy (RPN) is the treatment of choice for organ-confined renal tumors. For to improve functional outcomes, we designed an off-clamp and suture-free approach (SL) to limit the ischemic damage and destruction of the renal parenchyma caused, respectively, by temporary closure of the vessels of the renal hilum and by renorrhaphy (RR) (i.e. by the juxtaposition of the margins of resection of the enucleation bed, which is commonly performed at the end of tumor exeresis using suture threads stopped by surgical clips)
| Study group | Role | What they receive |
|---|---|---|
| RR-ocRPN | Experimental | Subjects assigned to group A will receive surgical treatment through robotic partial nephrectomy (RPN), through an off-clamp and sutureless approach (SL) Receives: Procedure: Robotic partial nephrectomy |
| SL-ocRPN | Active comparator | Subjects assigned to group B will receive surgical treatment of robotic partial nephrectomy (RPN), through temporary closure of the renal hilar vessels and renorrhaphy (RR), i.e. by juxtaposing the resection margins of the enucleation bed Receives: Procedure: Robotic partial nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trifecta rate
The Trifecta rate [defined as negative surgical margins, no major complications, no >30% glomerular filtration rate reduction] will be assessed and used to compare outcomes in the 2 arms.
Then prospectively demonstrate that sutureless (SL) ocRPN is non-inferior to RR ocRPN in terms of surgical outcome.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start7 Jul 2023
- Primary completion7 Jul 2028 (estimated)
- Study completion7 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Randomized trial on surgical techniques used in clinical practice, relating to patients with organ-confined renal tumors who are candidates for OCRPN surgery, designed with the aim of prospectively demonstrating that SL-ocRPN is not inferior to RR-ocRPN in terms of surgical results (expressed by the Trifecta rate)
- Masking
- None (open label)
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aldo Brassetti, Doctor, Principal investigator, IRCCS "Regina Elena" National Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846112
- Sponsor's protocol ID
- RS1835/23
- Status last verified
- Dec 2025
- First submitted
- 6 Mar 2024
- Last updated
- 17 Dec 2025
- 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 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Aimed at Comparing Unclamped Robotic Partial Nephrectomy With or Without Renorrhaphy. Randomized Control Trial Comparing Off-clamp Robotic Partial Nephrectomy With or Without Renorrhaphy. Project: GR-2021-12373396
- ClinicalTrials.gov ID
- NCT06846112
- Acronym / sponsor ID
- RS1835/23
- Conditions
- Kidney Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- 7 Jul 2023 (actual)
- Primary completion
- 7 Jul 2028 (estimated)
- Study completion
- 7 Jul 2028 (estimated)
- First posted
- 25 Feb 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.
Intended to minimize ischemia during robotic partial nephrectomy (RPN) procedures "by any means possible".
Before starting enucleation, the boundaries of the tumor are marked during SL-ocRPN surgery cautery. Once the tumor is removed, the resection bed is cauterized by dispensing monopolar energy with "quasi-contact" mode, and hemostasis is progressively improved.
Detailed description
Since RR impacts postoperative renal function, we believe the use of cautery instead of suture of the parenchymal breach after tumor enucleation provides at least postoperative functional results not lower, shorten the intervention time and reduce the direct costs associated with the procedure.
Based on available pilot studies, SL-ocRPN is safe, fast, and both the transfusion rate and duration of the hospital stay are not affected by the lack of renorrhaphy at the end of the enucleation. At the same time, this surgical approach does not require the use of a robotic needle holder and this can result in a reduction of direct costs related to treatment.
Furthermore, based on the preliminary data available, the rate of positive surgical margins would also not result influenced by the absence of RR and the risk of local recurrence could even be reduced by the extended one coagulation of the tumor bed after enucleation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized trial on surgical techniques used in clinical practice, relating to patients with organ-confined renal tumors who are candidates for OCRPN surgery, designed with the aim of prospectively demonstrating that SL-ocRPN is not inferior to RR-ocRPN in terms of surgical results (expressed by the Trifecta rate)
| Arm | Type | Receives |
|---|---|---|
| RR-ocRPN | Experimental | Procedure: Robotic partial nephrectomySubjects assigned to group A will receive surgical treatment through robotic partial nephrectomy (RPN), through an off-clamp and sutureless approach (SL) |
| SL-ocRPN | Active comparator | Procedure: Robotic partial nephrectomySubjects assigned to group B will receive surgical treatment of robotic partial nephrectomy (RPN), through temporary closure of the renal hilar vessels and renorrhaphy (RR), i.e. by juxtaposing the resection margins of the enucleation bed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age ≥ 18 years;
- radiological diagnosis of organ-confined renal neoplasm (cT1-2 cN0);
- patient who is a candidate, due to personal or tumor characteristics, for ocRPN intervention;
- compliant patient, able to follow the procedures/follow-up;
- patient who agrees to participate in the clinical study and the planned randomization, by signing the informed consent.
Key exclusion criteria (2 listed)
- preoperative evidence of unilateral/bilateral synchronous renal neoplasms;
- personal history of renal surgery for benign or malignant pathology.
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 |
|---|---|---|
| Robotic partial nephrectomyRobotic partial nephrectomy (RPN) is the treatment of choice for organ-confined renal tumors. For to improve functional outcomes, we designed an off-clamp and suture-free approach (SL) to limit the ischemic damage and destruction of the renal parenchyma caused, respectively, by temporary closure of the vessels of the renal hilum and by renorrhaphy (RR) (i.e. by the juxtaposition of the margins of resection of the enucleation bed, which is commonly performed at the end of tumor exeresis using suture threads stopped by surgical clips) | Procedure or surgery | RR-ocRPN, SL-ocRPN |
Primary outcome
Trifecta rate
Time frame: 36 months
The Trifecta rate [defined as negative surgical margins, no major complications, no >30% glomerular filtration rate reduction] will be assessed and used to compare outcomes in the 2 arms. Then prospectively demonstrate that sutureless (SL) ocRPN is non-inferior to RR ocRPN in terms of surgical outcome.
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 17 Dec 2025.
- 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. This study is not recruiting at the moment.
Aldo Brassetti, Doctor principal investigator
IRCCS "Regina Elena" National Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic partial nephrectomy in people with Kidney Cancer, run by Regina Elena Cancer Institute at 1 site in Italy.
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 5 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 17 Dec 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 Italy. 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?
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?
Trifecta rate (time frame: 36 months). 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 17 Dec 2025.