Renal TumorACCURATENCT05572216
A CCafU-UroCCR Randomized Trial: 3D Image-Guided Robot-AssisTEd Partial Nephrectomy for Renal Complex Tumor (UroCCR N°99)
A study testing Robot assisted partial nephrectomy with 3D image guidance in people with Renal Tumor and Renal Cancer, run by University Hospital, Grenoble at 2 sites in France.
Trial summary
The goal of this clinical trial is to evaluate peri and post-operative outcomes as well as long-term survival of 3D IGRAPN compared to conventional Robot-Assisted Partial Nephrectomy (RAPN) for moderate and highly complex renal tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Tumor, Renal Cancer
- What is being tested?
- Robot assisted partial nephrectomy with 3D image guidance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 694 participants
- Where
- 2 sitesFrance
- Study dates
- 24 Jan 2023to Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years
- Indication of RAPN for suspicious renal tumor
- Moderate or high complexity renal tumor (RENAL Nephrometry Score (NS) >7)
- Da Vinci® surgical system available for the surgery
- Patient affiliated to the French social security system or an equivalent system
- Signed informed consent form UroCCR and ACCURATE
Who cannot join
- Medical contraindication to RAPN
- Renal insufficiency forbidding iodine injection
- Patient with allergy to iodinated contrast products
- Patient concerned by articles L1121-5 to 8 of the French public health code (protected persons)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
University Hospital Grenoble
Grenoble, 38043
Jean-Luc DESCOTES, PR, 0476767642 ext. +33, jldescotes@chu-grenoble.fr
Assilah Bouzit, Study co, 0476767971 ext. +33, abouzit@chu-grenoble.fr
- Recruiting
university HospitalGrenoble
Grenoble, 38043
Jean-Luc DESCOTES, 0476767642 ext. +33, jldescotes@chu-grenoble.fr
assilah bouzit, 0476767971, abouzit@chu-grenoble.fr
About this study
The goal of this clinical trial is to evaluate peri and post-operative outcomes as well as long-term survival of 3D IGRAPN compared to conventional Robot-Assisted Partial Nephrectomy (RAPN) for moderate and highly complex renal tumors.
The main questions aim to answer:
- peri-operative complications
- oncological safety
- long term renal function Participants will be asked to do undergo 3D-IGRAPN. Researchers will compare 3D-IGRAPN to RAPN to see if peri-operative outcomes are better in the experimental group.
Read the detailed description
Robot-assisted partial nephrectomy (RAPN) is the standard treatment for localized kidney tumors. New 3D modeling and reconstruction technologies have enabled the development of real time imageguided surgery using virtual reality (VR). In view of advances in artificial intelligence and surface recognition based on deep-learning, augmented reality (AR) by merging a 3D reconstructed virtual image onto the real per-operative view represents the next step in image-guided surgery.
3D IG-RAPN using Synapse 3D (Fujifilm) and DaVinci Tile-Pro display (Intuitive Surgical) vs conventional RAPN without 3D navigation in 12 high-volume urological centers from the UroCCR Network.
Outcoume : Primary endpoint is a composite validated score (TRIFECTA) evaluating peri-operative complications as well as oncological safety and long-term renal function preservation. Secondary endpoints assess long-term survival, ergonomics and surgeon satisfaction. A medico-economic evaluation will be performed.
Methodology: ACCURATE is a nation-wide, single-blind, multicentric, prospective randomized controlled trial enrolling 694 patients with a single complex renal mass, defined as RENAL NS≥7.
Randomization (1:1) between the experimental and the conventional group will take place on day of inclusion and will be stratified by center.
- Conditions
- Renal Tumor, Renal Cancer
- Being tested
- Robot assisted partial nephrectomy with 3D image guidance
- Keywords
- image guidance, augmented reality, robotics
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot assisted partial nephrectomy with 3D image guidanceProcedure or surgery
Also called without 3D image guidance
patient have a partial nephrectomy for renal complex tumor
| Study group | Role | What they receive |
|---|---|---|
| conventional group | No intervention | Robot-Assisted Partial Nephrectomy without 3D navigation |
| 3D IGRAPN GROUP | Experimental | Robot-Assisted Partial Nephrectomy with 3D navigation Receives: Procedure: Robot assisted partial nephrectomy with 3D image guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
TRIFECTA score
evaluating peri-operative outcome complications as well as oncological safety and long-term renal function preservation.
Measured: 1 month
Secondary outcomes (9)
Recurrence free survival
Recurrence-free survival and Overall survival
Measured: 2 and 5 years
Overall survival
Overall Survival
Measured: 2 and 5 years
Number of Conversion to radical nephrectomy
Need to convert to radical nephrectomy for intra-operative reasons
Measured: Intraopertively
rate of Off clamp or superselective ischemia
use of techniques without renal artery clamping
Measured: Intraoperatively
Amount of parenchyma preserved (according to CT scan)
Preservation of safe kidney
Measured: Month 6
Blood loss
Blood loss
Measured: Intra-operatively
NASA TLX
Ergonomy score (questionnaire completed at the end of the procedure by the surgeon)
Measured: at the end of the surgery
Warm ischemia time
Warm ischemia time
Measured: Intra-operatively
Medico-economic evaluation
ncremental cost-utility ratio (ICUR) expressed as the extra cost per a QALY gained by the 3D-IGRAPN strategy compared to standard RAPN.
Measured: Month 1 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start24 Jan 2023
- Primary completion24 Jan 2023
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Renal TumorStudies 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
- Model description
- ACCURATE is a nation-wide, single-blind, multicentric, prospective randomized controlled trial enrolling patients with a single complex renal mass, defined as RENAL NS≥7. Randomization (1:1) between the experimental and the conventional group will take place on day of inclusion and will be stratified by center.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 694 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Luc DESCOTES, Pr, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572216
- Sponsor's protocol ID
- EssaiClinique_ACCURATE
- Acronym
- ACCURATE
- Status last verified
- Nov 2024
- First submitted
- 5 Oct 2022
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Michiels C, Khene ZE, Prudhomme T, Boulenger de Hauteclocque A, Cornelis FH, Percot M, Simeon H, Dupitout L, Bensadoun H, Capon G, Alezra E, Estrade V, Bladou F, Robert G, Ferriere JM, Grenier N, Doumerc N, Bensalah K, Bernhard JC. 3D-Image guided robotic-assisted partial nephrectomy: a multi-institutional propensity score-matched analysis (UroCCR study 51). World J Urol. 2023 Feb;41(2):303-313. doi: 10.1007/s00345-021-03645-1. Epub 2021 Apr 2.
PubMed 33811291Porpiglia F, Checcucci E, Amparore D, Piramide F, Volpi G, Granato S, Verri P, Manfredi M, Bellin A, Piazzolla P, Autorino R, Morra I, Fiori C, Mottrie A. Three-dimensional Augmented Reality Robot-assisted Partial Nephrectomy in Case of Complex Tumours (PADUA >/=10): A New Intraoperative Tool Overcoming the Ultrasound Guidance. Eur Urol. 2020 Aug;78(2):229-238. doi: 10.1016/j.eururo.2019.11.024. Epub 2019 Dec 30.
PubMed 31898992Long JA, Fiard G, Giai J, Teyssier Y, Fontanell A, Overs C, Poncet D, Descotes JL, Rambeaud JJ, Moreau-Gaudry A, Ittobane T, Bouzit A, Bosson JL, Lanchon C. Superselective Ischemia in Robotic Partial Nephrectomy Does Not Provide Better Long-term Renal Function than Renal Artery Clamping in a Randomized Controlled Trial (EMERALD): Should We Take the Risk? Eur Urol Focus. 2022 May;8(3):769-776. doi: 10.1016/j.euf.2021.04.009. Epub 2021 Apr 27.
PubMed 33931361
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A CCafU-UroCCR Randomized Trial: 3D Image-Guided Robot-AssisTEd Partial Nephrectomy for Renal Complex Tumor (UroCCR N°99)
- ClinicalTrials.gov ID
- NCT05572216
- Acronym / sponsor ID
- ACCURATE / EssaiClinique_ACCURATE
- Conditions
- Renal Tumor, Renal Cancer
- Keywords
- image guidance, augmented reality, robotics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 694 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- 24 Jan 2023 (actual)
- Study completion
- Nov 2027 (estimated)
- First posted
- 7 Oct 2022 (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.
The goal of this clinical trial is to evaluate peri and post-operative outcomes as well as long-term survival of 3D IGRAPN compared to conventional Robot-Assisted Partial Nephrectomy (RAPN) for moderate and highly complex renal tumors.
The main questions aim to answer:
- peri-operative complications
- oncological safety
- long term renal function Participants will be asked to do undergo 3D-IGRAPN. Researchers will compare 3D-IGRAPN to RAPN to see if peri-operative outcomes are better in the experimental group.
Detailed description
Robot-assisted partial nephrectomy (RAPN) is the standard treatment for localized kidney tumors. New 3D modeling and reconstruction technologies have enabled the development of real time imageguided surgery using virtual reality (VR). In view of advances in artificial intelligence and surface recognition based on deep-learning, augmented reality (AR) by merging a 3D reconstructed virtual image onto the real per-operative view represents the next step in image-guided surgery.
3D IG-RAPN using Synapse 3D (Fujifilm) and DaVinci Tile-Pro display (Intuitive Surgical) vs conventional RAPN without 3D navigation in 12 high-volume urological centers from the UroCCR Network.
Outcoume : Primary endpoint is a composite validated score (TRIFECTA) evaluating peri-operative complications as well as oncological safety and long-term renal function preservation. Secondary endpoints assess long-term survival, ergonomics and surgeon satisfaction. A medico-economic evaluation will be performed.
Methodology: ACCURATE is a nation-wide, single-blind, multicentric, prospective randomized controlled trial enrolling 694 patients with a single complex renal mass, defined as RENAL NS≥7.
Randomization (1:1) between the experimental and the conventional group will take place on day of inclusion and will be stratified by center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- ACCURATE is a nation-wide, single-blind, multicentric, prospective randomized controlled trial enrolling patients with a single complex renal mass, defined as RENAL NS≥7. Randomization (1:1) between the experimental and the conventional group will take place on day of inclusion and will be stratified by center.
| Arm | Type | Receives |
|---|---|---|
| conventional group | No intervention | –Robot-Assisted Partial Nephrectomy without 3D navigation |
| 3D IGRAPN GROUP | Experimental | Procedure: Robot assisted partial nephrectomy with 3D image guidanceRobot-Assisted Partial Nephrectomy with 3D navigation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients over 18 years
- Indication of RAPN for suspicious renal tumor
- Moderate or high complexity renal tumor (RENAL Nephrometry Score (NS) >7)
- Da Vinci® surgical system available for the surgery
- Patient affiliated to the French social security system or an equivalent system
Key exclusion criteria (4 listed)
- Medical contraindication to RAPN
- Renal insufficiency forbidding iodine injection
- Patient with allergy to iodinated contrast products
- Patient concerned by articles L1121-5 to 8 of the French public health code (protected persons)
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 |
|---|---|---|
| Robot assisted partial nephrectomy with 3D image guidanceAlso: without 3D image guidancepatient have a partial nephrectomy for renal complex tumor | Procedure or surgery | 3D IGRAPN GROUP |
Primary outcome
TRIFECTA score
Time frame: 1 month
evaluating peri-operative outcome complications as well as oncological safety and long-term renal function preservation.
9 secondary outcomes
Recurrence free survival
Time frame: 2 and 5 years
Overall survival
Time frame: 2 and 5 years
Number of Conversion to radical nephrectomy
Time frame: Intraopertively
rate of Off clamp or superselective ischemia
Time frame: Intraoperatively
Amount of parenchyma preserved (according to CT scan)
Time frame: Month 6
Blood loss
Time frame: Intra-operatively
NASA TLX
Time frame: at the end of the surgery
Warm ischemia time
Time frame: Intra-operatively
Medico-economic evaluation
Time frame: Month 1 and 6
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 18 Nov 2024.
- Results publication: PubMed 33811291Michiels C, Khene ZE, Prudhomme T, Boulenger de Hauteclocque A, Cornelis FH, Percot M, Simeon H, Dupitout L, Bensadoun H, Capon G, Alezra E, Estrade V, Bladou F, Robert G, Ferriere JM, Grenier N, Doumerc N, Bensalah K, Bernhard JC. 3D-Image guided robotic-assisted partial nephrectomy: a multi-institutional propensity score-matched analysis (UroCCR study 51). World J Urol. 2023 Feb;41(2):303-313. doi: 10.1007/s00345-021-03645-1. Epub 2021 Apr 2.
- Results publication: PubMed 31898992Porpiglia F, Checcucci E, Amparore D, Piramide F, Volpi G, Granato S, Verri P, Manfredi M, Bellin A, Piazzolla P, Autorino R, Morra I, Fiori C, Mottrie A. Three-dimensional Augmented Reality Robot-assisted Partial Nephrectomy in Case of Complex Tumours (PADUA >/=10): A New Intraoperative Tool Overcoming the Ultrasound Guidance. Eur Urol. 2020 Aug;78(2):229-238. doi: 10.1016/j.eururo.2019.11.024. Epub 2019 Dec 30.
- Results publication: PubMed 33931361Long JA, Fiard G, Giai J, Teyssier Y, Fontanell A, Overs C, Poncet D, Descotes JL, Rambeaud JJ, Moreau-Gaudry A, Ittobane T, Bouzit A, Bosson JL, Lanchon C. Superselective Ischemia in Robotic Partial Nephrectomy Does Not Provide Better Long-term Renal Function than Renal Artery Clamping in a Randomized Controlled Trial (EMERALD): Should We Take the Risk? Eur Urol Focus. 2022 May;8(3):769-776. doi: 10.1016/j.euf.2021.04.009. Epub 2021 Apr 27.
- 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.
Jean-Luc DESCOTES, Pr principal investigator
University Hospital, Grenoble
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot assisted partial nephrectomy with 3D image guidance in people with Renal Tumor and Renal Cancer, run by University Hospital, Grenoble at 2 sites in France.
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 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 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 Jean-Luc DESCOTES, Pr (0476767642 ext. +33, jldescotes@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TRIFECTA score (time frame: 1 month). 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 NCT05572216, which also lists 3 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 18 Nov 2024.