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

NCT05572216 | Recruiting DMC

• 1 other identifier: EssaiClinique_ACCURATE
• Study Type: interventional
• Target: 694
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Renal Tumor; Renal Cancer

Keywords

image guidance; augmented reality; robotics

Outcome Measures

Primary Outcomes (1)

• TRIFECTA score

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

  1 month

Secondary Outcomes (9)

• Recurrence free survival

  2 and 5 years

• Overall survival

  2 and 5 years

• Number of Conversion to radical nephrectomy

  Intraopertively

• rate of Off clamp or superselective ischemia

  Intraoperatively

• Amount of parenchyma preserved (according to CT scan)

  Month 6

Study Arms (2)

conventional group

NO INTERVENTION

Robot-Assisted Partial Nephrectomy without 3D navigation

3D IGRAPN GROUP

EXPERIMENTAL

Robot-Assisted Partial Nephrectomy with 3D navigation

Procedure: Robot assisted partial nephrectomy with 3D image guidance

Interventions

Robot assisted partial nephrectomy with 3D image guidance PROCEDURE

patient have a partial nephrectomy for renal complex tumor

Also known as: without 3D image guidance

3D IGRAPN GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (2)

University Hospital Grenoble

Grenoble, 38043, France

RECRUITING

university HospitalGrenoble

Grenoble, 38043, France

RECRUITING

Related Publications (3)

• 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.

  PMID: 33811291 BACKGROUND

• Porpiglia 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.

  PMID: 31898992 BACKGROUND

• Long 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.

  PMID: 33931361 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Jean-Luc DESCOTES, Pr

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Luc DESCOTES, Pr

CONTACT

0476767642; jldescotes@chu-grenoble.fr

ASSILAH BOUZIT

CONTACT

0476767971; abouzit@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 7, 2022
• Study Start: January 24, 2023
• Primary Completion: January 24, 2023
• Study Completion (Estimated): November 1, 2027
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)