A CCafU-UroCCR Randomized Trial: 3D Image-Guided Robot-AssisTEd Partial Nephrectomy for Renal Complex Tumor (UroCCR N°99) (ACCURATE)

October 6, 2022 updated by: University Hospital, Grenoble

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

694

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: conventional group
Robot-Assisted Partial Nephrectomy without 3D navigation
Experimental: 3D IGRAPN GROUP
Robot-Assisted Partial Nephrectomy with 3D navigation
Procedure: Robot assisted partial nephrectomy with 3D image guidance
patient have a partial nephrectomy for renal complex tumor
Other Names:
  • without 3D image guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TRIFECTA score
Time Frame: 1 month
evaluating peri-operative outcome complications as well as oncological safety and long-term renal function preservation.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence free survival
Time Frame: 2 and 5 years
Recurrence-free survival and Overall survival
2 and 5 years
Overall survival
Time Frame: 2 and 5 years
Overall Survival
2 and 5 years
Number of Conversion to radical nephrectomy
Time Frame: Intraopertively
Need to convert to radical nephrectomy for intra-operative reasons
Intraopertively
rate of Off clamp or superselective ischemia
Time Frame: Intraoperatively
use of techniques without renal artery clamping
Intraoperatively
Amount of parenchyma preserved (according to CT scan)
Time Frame: Month 6
Preservation of safe kidney
Month 6
Blood loss
Time Frame: Intra-operatively
Blood loss
Intra-operatively
NASA TLX
Time Frame: at the end of the surgery
Ergonomy score (questionnaire completed at the end of the procedure by the surgeon)
at the end of the surgery
Warm ischemia time
Time Frame: Intra-operatively
Warm ischemia time
Intra-operatively
Medico-economic evaluation
Time Frame: Month 1 and 6
ncremental cost-utility ratio (ICUR) expressed as the extra cost per a QALY gained by the 3D-IGRAPN strategy compared to standard RAPN.
Month 1 and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Jean-Alexandre LONG, Pr, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

November 1, 2027

Study Registration Dates

First Submitted

October 5, 2022

First Submitted That Met QC Criteria

October 6, 2022

First Posted (Actual)

October 7, 2022

Study Record Updates

Last Update Posted (Actual)

October 7, 2022

Last Update Submitted That Met QC Criteria

October 6, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EssaiClinique_ACCURATE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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