Renal CancerVPN x RANPNCT06441851
Study to Compare Two Partial Nephrectomy Techniques for Renal Tumors: Robot-assisted vs Videolaparoscopic
A study testing Videolaparoscopic Partial Nephrectomy and Robot-assisted Partial Nephrectomy in people with Renal Cancer, run by Instituto do Cancer do Estado de São Paulo.
Trial summary
Randomized, open-label clinical trial to compare renal volumetry pre and post operative in patients undergoing two types of partial nephrectomy techniques for renal tumors: robot-assisted vs videolaparoscopic. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Renal Cancer
- What is being tested?
- Videolaparoscopic Partial Nephrectomy and Robot-assisted Partial Nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Jul 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 18 and 99 years old;
- Patients with non-metastatic renal cancer (confirmed by pre operatory TC);
- Patients eligible for videolaparoscopic partial nephrectomy;
- Patients who signed study informed consent form
Who cannot join
- Pregnant patients;
- Patients with concomitant indications with nephrectomy;
- Patients with a clinical condition that contraindicates nephrectomy;
- Patients with a clinical condition that contraindicates robot-assisted surgeries (determined by urology team);
- Patients with previous surgeries that contraindicates robot-assisted surgeries (determined by urology team);
About this study
Official title: Randomized Clinical Trial to Compare Two Partial Nephrectomy Techniques for Renal Tumors: Robot-assisted vs Videolaparoscopic
Randomized, open-label clinical trial to compare renal volumetry pre and post operative in patients undergoing two types of partial nephrectomy techniques for renal tumors: robot-assisted vs videolaparoscopic.
Read the detailed description
Renal tumors are an important public health issue, representing approximately 4,2% of all newly diagnosed cancers around the world. Renal tumors are more prevalent in adults over 45 years old, and with higher frequency in men than women. Many risks factor have already been identified, including smoking (increase in twice the renal cancer risk), obesity, hypertension, and renal cancer familiar history.
Surgery is one of the main treatment options for renal tumors and is considered the only curative treatment for localized ones. The most common surgeries used to treat it are Partial Nephrectomy (PN) and Radical Nephrectomy (RN). PN in indicated for smaller tumors (smaller than 4cm size) once it has already demonstrated renal function preservation and decrease chronic kidney disease (CDK) risk and cardiovascular events. Furthermore, RN is indicated for bigger tumors or for those who are centrally located in the middle of the kidney.
In the last years, PN use have been increased and consequently, RN use has been decreased.
According to a recent published study, PN use for T1a tumors increased from 20,2% in 2004, to 59,7% in 2015. Furthermore, 5-year cancer survival rates between patients undergone PN or RN was similar, with PN being more associated with lower general mortality rates. However, PN is technically more challenging and is associated with complications and local higher recurrence risks.
Both are viable surgery options for renal tumors and the chosen technique of them should be considered according to surgeon expertise, patient's comorbidities, and tumor characteristics.
There are some PN ways, including Open (OPN), Laparoscopic (LPN) and robot-assisted (RAPN), however the best technique is still unknown. Some studies have been comparing this three, and a recent 39-studies metanalysis evaluating 11.310 patients reported RAPN is which presented lower general complications, less warm ischemia period, and higher kidney function preservation rates in comparison with LPN or OPN. Other 29-studies metanalysis evaluating 5952 patients showed RAPN presented lower surgical and hospitalization periods compared to OPN and LPN. However, RANP is associated with higher costs and a longer learning curve than other NP techniques.
Renal volumetry is an important measure for kidney function evaluation which aids on surgical approach choose for NP. In the present, there are some ways to evaluate pre and post operative kidney volumetry such as TC, RMN, and 3D ultrasonography (3DUS). A systematic review and metanalysis of 26 studies analyzed 1918 patients, and showed TC preoperative renal volumetry is the best way to predict postoperative kidney function and the need for a NP. Renal volumetry by TC and RMN postoperative also were considered good trustful measures to evaluate volumetry and remained kidney functions after PN. 3DUS appear to be a more economic and good measure to evaluate it with a good precision compared to what was found to TC and RMN.
In general, pre and postoperative renal volumetry are an important measure to guide surgeons on the best surgery approach in PN, and right renal volumetry image evaluation should be considered according to costs available, patients characteristics and surgeon experience. Then, this study aims to compare NP techniques (VPN and RAPN) using renal volumetry pre and postoperative.
- Conditions
- Renal Cancer
- Being tested
- Videolaparoscopic Partial Nephrectomy, Robot-assisted Partial Nephrectomy
- Keywords
- Renal cancer, Nephrectomy, Partial nephrectomy, Videolaparoscopic partial nephrectomy, Robot-assisted 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.
Videolaparoscopic Partial NephrectomyProcedure or surgery
Also called VPN
Videolaparoscopic partial nephrectomy
Robot-assisted Partial NephrectomyProcedure or surgery
Also called RAPN
Robot-assisted partial nephrectomy
| Study group | Role | What they receive |
|---|---|---|
| Videolaparoscopic Partial Nephrectomy (VPN) | Active comparator | Patients randomized to VPN group will be submitted to a videolaparoscopic partial nephrectomy in which lesion will be identified, renal artery will be selectively clamped and renal parenchyma will be section with scissors and cautery. Suture will be made in two planes with absorbable sutures. Receives: Procedure: Videolaparoscopic Partial Nephrectomy |
| Robot-assisted Partial Nephrectomy (RANP) | Experimental | Patients randomized to RAN'P group will be submitted to a robot-assisted partial nephrectomy in which lesion will be identified, renal artery will be selectively clamped and renal parenchyma will be section with scissors and cautery. Suture will be made in two planes with absorbable sutures. Receives: Procedure: Robot-assisted Partial Nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal volumetry
Renal volumetry measured by computadorized tomography
Measured: Up to 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study startJul 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Renal 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MAURICIO DENER CORDEIRO, Instituto do Cancer do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441851
- Sponsor's protocol ID
- NP5030/2023
- Acronym
- VPN x RANP
- Status last verified
- Jun 2024
- First submitted
- 28 Apr 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Campbell S, Uzzo RG, Allaf ME, Bass EB, Cadeddu JA, Chang A, Clark PE, Davis BJ, Derweesh IH, Giambarresi L, Gervais DA, Hu SL, Lane BR, Leibovich BC, Pierorazio PM. Renal Mass and Localized Renal Cancer: AUA Guideline. J Urol. 2017 Sep;198(3):520-529. doi: 10.1016/j.juro.2017.04.100. Epub 2017 May 4.
PubMed 28479239Kutikov A, Uzzo RG. The R.E.N.A.L. nephrometry score: a comprehensive standardized system for quantitating renal tumor size, location and depth. J Urol. 2009 Sep;182(3):844-53. doi: 10.1016/j.juro.2009.05.035. Epub 2009 Jul 17.
PubMed 19616235Thompson RH, Lane BR, Lohse CM, Leibovich BC, Fergany A, Frank I, Gill IS, Blute ML, Campbell SC. Every minute counts when the renal hilum is clamped during partial nephrectomy. Eur Urol. 2010 Sep;58(3):340-5. doi: 10.1016/j.eururo.2010.05.047. Epub 2010 Jun 9.
PubMed 20825756Kim SP, Thompson RH, Boorjian SA, Weight CJ, Han LC, Murad MH, Shippee ND, Erwin PJ, Costello BA, Chow GK, Leibovich BC. Comparative effectiveness for survival and renal function of partial and radical nephrectomy for localized renal tumors: a systematic review and meta-analysis. J Urol. 2012 Jul;188(1):51-7. doi: 10.1016/j.juro.2012.03.006. Epub 2012 May 14.
PubMed 22591957Kutikov A, Egleston BL, Canter D, Smaldone MC, Wong YN, Uzzo RG. Competing risks of death in patients with localized renal cell carcinoma: a comorbidity based model. J Urol. 2012 Dec;188(6):2077-83. doi: 10.1016/j.juro.2012.07.100. Epub 2012 Oct 18.
PubMed 23083850Venkatesan AM, Kundu S, Sacks D, Wallace MJ, Wojak JC, Rose SC, Clark TW, d'Othee BJ, Itkin M, Jones RS, Miller DL, Owens CA, Rajan DK, Stokes LS, Swan TL, Towbin RB, Cardella JF; Society of Interventional Radiology Standards of Practice Committee. Practice guidelines for adult antibiotic prophylaxis during vascular and interventional radiology procedures. Written by the Standards of Practice Committee for the Society of Interventional Radiology and Endorsed by the Cardiovascular Interventional Radiological Society of Europe and Canadian Interventional Radiology Association [corrected]. J Vasc Interv Radiol. 2010 Nov;21(11):1611-30; quiz 1631. doi: 10.1016/j.jvir.2010.07.018. No abstract available.
PubMed 21029949Lane BR, Abouassaly R, Gao T, Weight CJ, Hernandez AV, Larson BT, Kaouk JH, Gill IS, Campbell SC. Active treatment of localized renal tumors may not impact overall survival in patients aged 75 years or older. Cancer. 2010 Jul 1;116(13):3119-26. doi: 10.1002/cncr.25184.
PubMed 20564627Zini L, Perrotte P, Capitanio U, Jeldres C, Shariat SF, Antebi E, Saad F, Patard JJ, Montorsi F, Karakiewicz PI. Radical versus partial nephrectomy: effect on overall and noncancer mortality. Cancer. 2009 Apr 1;115(7):1465-71. doi: 10.1002/cncr.24035.
PubMed 19195042Ficarra V, Novara G, Secco S, Macchi V, Porzionato A, De Caro R, Artibani W. Preoperative aspects and dimensions used for an anatomical (PADUA) classification of renal tumours in patients who are candidates for nephron-sparing surgery. Eur Urol. 2009 Nov;56(5):786-93. doi: 10.1016/j.eururo.2009.07.040. Epub 2009 Aug 4.
PubMed 19665284
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Compare Two Partial Nephrectomy Techniques for Renal Tumors: Robot-assisted vs Videolaparoscopic
- ClinicalTrials.gov ID
- NCT06441851
- Acronym / sponsor ID
- VPN x RANP / NP5030/2023
- Conditions
- Renal Cancer
- Keywords
- Renal cancer, Nephrectomy, Partial nephrectomy, Videolaparoscopic partial nephrectomy, Robot-assisted partial nephrectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 4 Jun 2024 (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.
Randomized, open-label clinical trial to compare renal volumetry pre and post operative in patients undergoing two types of partial nephrectomy techniques for renal tumors: robot-assisted vs videolaparoscopic.
Detailed description
Renal tumors are an important public health issue, representing approximately 4,2% of all newly diagnosed cancers around the world. Renal tumors are more prevalent in adults over 45 years old, and with higher frequency in men than women. Many risks factor have already been identified, including smoking (increase in twice the renal cancer risk), obesity, hypertension, and renal cancer familiar history.
Surgery is one of the main treatment options for renal tumors and is considered the only curative treatment for localized ones. The most common surgeries used to treat it are Partial Nephrectomy (PN) and Radical Nephrectomy (RN). PN in indicated for smaller tumors (smaller than 4cm size) once it has already demonstrated renal function preservation and decrease chronic kidney disease (CDK) risk and cardiovascular events. Furthermore, RN is indicated for bigger tumors or for those who are centrally located in the middle of the kidney.
In the last years, PN use have been increased and consequently, RN use has been decreased.
According to a recent published study, PN use for T1a tumors increased from 20,2% in 2004, to 59,7% in 2015. Furthermore, 5-year cancer survival rates between patients undergone PN or RN was similar, with PN being more associated with lower general mortality rates. However, PN is technically more challenging and is associated with complications and local higher recurrence risks.
Both are viable surgery options for renal tumors and the chosen technique of them should be considered according to surgeon expertise, patient's comorbidities, and tumor characteristics.
There are some PN ways, including Open (OPN), Laparoscopic (LPN) and robot-assisted (RAPN), however the best technique is still unknown. Some studies have been comparing this three, and a recent 39-studies metanalysis evaluating 11.310 patients reported RAPN is which presented lower general complications, less warm ischemia period, and higher kidney function preservation rates in comparison with LPN or OPN. Other 29-studies metanalysis evaluating 5952 patients showed RAPN presented lower surgical and hospitalization periods compared to OPN and LPN. However, RANP is associated with higher costs and a longer learning curve than other NP techniques.
Renal volumetry is an important measure for kidney function evaluation which aids on surgical approach choose for NP. In the present, there are some ways to evaluate pre and post operative kidney volumetry such as TC, RMN, and 3D ultrasonography (3DUS). A systematic review and metanalysis of 26 studies analyzed 1918 patients, and showed TC preoperative renal volumetry is the best way to predict postoperative kidney function and the need for a NP. Renal volumetry by TC and RMN postoperative also were considered good trustful measures to evaluate volumetry and remained kidney functions after PN. 3DUS appear to be a more economic and good measure to evaluate it with a good precision compared to what was found to TC and RMN.
In general, pre and postoperative renal volumetry are an important measure to guide surgeons on the best surgery approach in PN, and right renal volumetry image evaluation should be considered according to costs available, patients characteristics and surgeon experience. Then, this study aims to compare NP techniques (VPN and RAPN) using renal volumetry pre and postoperative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Videolaparoscopic Partial Nephrectomy (VPN) | Active comparator | Procedure: Videolaparoscopic Partial NephrectomyPatients randomized to VPN group will be submitted to a videolaparoscopic partial nephrectomy in which lesion will be identified, renal artery will be selectively clamped and renal parenchyma will be section with scissors and cautery. Suture will be made in two planes with absorbable sutures. |
| Robot-assisted Partial Nephrectomy (RANP) | Experimental | Procedure: Robot-assisted Partial NephrectomyPatients randomized to RAN'P group will be submitted to a robot-assisted partial nephrectomy in which lesion will be identified, renal artery will be selectively clamped and renal parenchyma will be section with scissors and cautery. Suture will be made in two planes with absorbable sutures. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients between 18 and 99 years old;
- Patients with non-metastatic renal cancer (confirmed by pre operatory TC);
- Patients eligible for videolaparoscopic partial nephrectomy;
- Patients who signed study informed consent form
Key exclusion criteria (5 listed)
- Pregnant patients;
- Patients with concomitant indications with nephrectomy;
- Patients with a clinical condition that contraindicates nephrectomy;
- Patients with a clinical condition that contraindicates robot-assisted surgeries (determined by urology team);
- Patients with previous surgeries that contraindicates robot-assisted surgeries (determined by urology team);
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 |
|---|---|---|
| Videolaparoscopic Partial NephrectomyAlso: VPNVideolaparoscopic partial nephrectomy | Procedure or surgery | Videolaparoscopic Partial Nephrectomy (VPN) |
| Robot-assisted Partial NephrectomyAlso: RAPNRobot-assisted partial nephrectomy | Procedure or surgery | Robot-assisted Partial Nephrectomy (RANP) |
Primary outcome
Renal volumetry
Time frame: Up to 6 months after surgery
Renal volumetry measured by computadorized tomography
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 4 Jun 2024.
- Background: PubMed 28479239Campbell S, Uzzo RG, Allaf ME, Bass EB, Cadeddu JA, Chang A, Clark PE, Davis BJ, Derweesh IH, Giambarresi L, Gervais DA, Hu SL, Lane BR, Leibovich BC, Pierorazio PM. Renal Mass and Localized Renal Cancer: AUA Guideline. J Urol. 2017 Sep;198(3):520-529. doi: 10.1016/j.juro.2017.04.100. Epub 2017 May 4.
- Background: PubMed 19616235Kutikov A, Uzzo RG. The R.E.N.A.L. nephrometry score: a comprehensive standardized system for quantitating renal tumor size, location and depth. J Urol. 2009 Sep;182(3):844-53. doi: 10.1016/j.juro.2009.05.035. Epub 2009 Jul 17.
- Background: PubMed 20825756Thompson RH, Lane BR, Lohse CM, Leibovich BC, Fergany A, Frank I, Gill IS, Blute ML, Campbell SC. Every minute counts when the renal hilum is clamped during partial nephrectomy. Eur Urol. 2010 Sep;58(3):340-5. doi: 10.1016/j.eururo.2010.05.047. Epub 2010 Jun 9.
- Background: PubMed 22591957Kim SP, Thompson RH, Boorjian SA, Weight CJ, Han LC, Murad MH, Shippee ND, Erwin PJ, Costello BA, Chow GK, Leibovich BC. Comparative effectiveness for survival and renal function of partial and radical nephrectomy for localized renal tumors: a systematic review and meta-analysis. J Urol. 2012 Jul;188(1):51-7. doi: 10.1016/j.juro.2012.03.006. Epub 2012 May 14.
- Background: PubMed 23083850Kutikov A, Egleston BL, Canter D, Smaldone MC, Wong YN, Uzzo RG. Competing risks of death in patients with localized renal cell carcinoma: a comorbidity based model. J Urol. 2012 Dec;188(6):2077-83. doi: 10.1016/j.juro.2012.07.100. Epub 2012 Oct 18.
- Background: PubMed 21029949Venkatesan AM, Kundu S, Sacks D, Wallace MJ, Wojak JC, Rose SC, Clark TW, d'Othee BJ, Itkin M, Jones RS, Miller DL, Owens CA, Rajan DK, Stokes LS, Swan TL, Towbin RB, Cardella JF; Society of Interventional Radiology Standards of Practice Committee. Practice guidelines for adult antibiotic prophylaxis during vascular and interventional radiology procedures. Written by the Standards of Practice Committee for the Society of Interventional Radiology and Endorsed by the Cardiovascular Interventional Radiological Society of Europe and Canadian Interventional Radiology Association [corrected]. J Vasc Interv Radiol. 2010 Nov;21(11):1611-30; quiz 1631. doi: 10.1016/j.jvir.2010.07.018. No abstract available.
- Background: PubMed 20564627Lane BR, Abouassaly R, Gao T, Weight CJ, Hernandez AV, Larson BT, Kaouk JH, Gill IS, Campbell SC. Active treatment of localized renal tumors may not impact overall survival in patients aged 75 years or older. Cancer. 2010 Jul 1;116(13):3119-26. doi: 10.1002/cncr.25184.
- Background: PubMed 19195042Zini L, Perrotte P, Capitanio U, Jeldres C, Shariat SF, Antebi E, Saad F, Patard JJ, Montorsi F, Karakiewicz PI. Radical versus partial nephrectomy: effect on overall and noncancer mortality. Cancer. 2009 Apr 1;115(7):1465-71. doi: 10.1002/cncr.24035.
- Background: PubMed 19665284Ficarra V, Novara G, Secco S, Macchi V, Porzionato A, De Caro R, Artibani W. Preoperative aspects and dimensions used for an anatomical (PADUA) classification of renal tumours in patients who are candidates for nephron-sparing surgery. Eur Urol. 2009 Nov;56(5):786-93. doi: 10.1016/j.eururo.2009.07.040. Epub 2009 Aug 4.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Videolaparoscopic Partial Nephrectomy and Robot-assisted Partial Nephrectomy in people with Renal Cancer, run by Instituto do Cancer do Estado de São Paulo.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Renal volumetry (time frame: Up to 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06441851, which also lists 9 linked publications.
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 4 Jun 2024.