Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy (3DPN)

University of Leipzig

Status: Enrolling

Conditions: Kidney Tumor

Treatments: Device: Innersight 3D software; Device: DaVinci Robot; Procedure: partial kidney nephrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06056505

3DPN

Details and patient eligibility

About

The primary objective is to determine if 3D modelling shortens total console operation time as a surrogate endpoint for clinical outcomes like perioperative complications and morbidity in robotic-assisted partial nephrectomy.

Full description

3DPN is a prospective, multicentre, randomised, controlled, two-armed, open trial to compare the 3D modelling with the 2D modelling in robotic-assisted partial nephrectomy. According to the randomisation the 3D or 2D modelling is used for patient information (before intervention) and for partial nephrectomy. A six-month follow-up visit is provided.

Enrollment: 370 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with kidney tumours ≤ 7cm and planned robotic-assisted partial nephrectomy with the DaVinci Surgical System
• CT scan with contrast medium available
• Age ≥ 18 years
• Written informed consent

Exclusion criteria

• History of surgery on affected kidney (e.g., partial nephrectomy, pyeloplasty, kidney cyst deroofing, percutaneous nephrolitholapaxy, radiofrequency ablation)
• Horseshoe kidney
• Previous malignancy with ongoing or planned nephrotoxic chemotherapy
• Patient is immunosuppressed (e.g., organ transplantation, leukaemia)
• Tumor thrombus in Vena renalis or Vena cava inferior
• Existing renal insufficiency GFR < 15 ml/min/1.73m2
• Severe cognitive impairment
• Pregnancy or lactation or women with desire for children
• Patients under legal supervision or guardianship
• Unable to give informed consent or suspected lack of compliance
• Patients who refuse to data collection and storage for the main study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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370 participants in 2 patient groups

Partial kidney nephrectomy with aid of 3D model

Experimental group

Description:

The patient information (before intervention) and the surgery (partial nephrectomy) will be performed with the aid of 3D modelling of the kidney.

Treatment:

Procedure: partial kidney nephrectomy

Device: Innersight 3D software

Device: DaVinci Robot

Partial kidney nephrectomy with aid of 2D model

Active Comparator group

Description:

The patient information (before intervention) and the surgery (partial nephrectomy) will be performed with the aid of 2D modelling of the kidney.

Treatment:

Procedure: partial kidney nephrectomy

Device: DaVinci Robot