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NCT Number: NCT05572216

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

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.

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Key information

Conditions

Renal Tumor Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Renal Cancer Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Grenoble, Grenoble, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Robot assisted partial nephrectomy with 3D image guidance

Procedure

patient have a partial nephrectomy for renal complex tumor

Other names: without 3D image guidance

Primary outcomes

  1. TRIFECTA score

    Time frame: 1 month

    evaluating peri-operative outcome complications as well as oncological safety and long-term renal function preservation.

Secondary outcomes

  1. Recurrence free survival

    Time frame: 2 and 5 years

    Recurrence-free survival and Overall survival

  2. Overall survival

    Time frame: 2 and 5 years

    Overall Survival

  3. Number of Conversion to radical nephrectomy

    Time frame: Intraopertively

    Need to convert to radical nephrectomy for intra-operative reasons

  4. rate of Off clamp or superselective ischemia

    Time frame: Intraoperatively

    use of techniques without renal artery clamping

  5. Amount of parenchyma preserved (according to CT scan)

    Time frame: Month 6

    Preservation of safe kidney

  6. Blood loss

    Time frame: Intra-operatively

    Blood loss

  7. NASA TLX

    Time frame: at the end of the surgery

    Ergonomy score (questionnaire completed at the end of the procedure by the surgeon)

  8. Warm ischemia time

    Time frame: Intra-operatively

    Warm ischemia time

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

ASSILAH BOUZIT

CONTACT

[email protected]

0476767971 ext. +33

Jean-Luc DESCOTES, Pr

CONTACT

[email protected]

0476767642 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: ACCURATE

Important dates

Study start
2023
Primary completion
2023
Study completion
2027
First posted
Oct 7, 2022
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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