Navigated Partial Nephrectomy

NCT ID: NCT07315100

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-20
• Study Completion Date: 2025-11-17

Brief Summary

This study aims to evaluate electromagnetic (EM) tracked navigation in robot-assisted partial nephrectomy (RAPN), addressing kidney movement issues by attaching a tracked EM sensor close to the lesion. This assessment will be based on the navigation's ability to achieve preoperatively planned resection volumes aiming to assist in radical resection margins of the lesion. The current challenge for surgeons performing RAPN is to minimize the removal of healthy kidney tissue, as the rates of positive resections are very low. Additionally, the study aims to explore the practical application of image guidance in RAPN, evaluating aspects such as duration, surgical and technical success, and the surgeons' perceptions. Ultimately, this research seeks to determine if the addition of navigation can enhance RAPN outcomes, particularly in terms of kidney tissue preservation and radical lesion removal. The success of this technique could result in broader adoption of kidney-sparing surgeries, even in complex scenarios where radical resection is at risk.

Detailed Description

Robot-assisted partial nephrectomy (RAPN) is now the preferred option for treatable renal lesions due to its ability to preserve kidney function while effectively treating cancer. Despite RAPN's effectiveness, its surgical complexity and varied approach requirements pose challenges. Image-guided surgery applies pre-operative imaging for patient-specific intra-operative visualization of the kidney and lesion margins to support the surgeon during resection. However, adapting to surgery-induced deformations remains a challenge. An approach that is able to correct for organ movements during surgery might result in an optimal preservation rate of healthy kidney parenchyma and improved decisiveness for the surgeon during resection. On the long term, this might result in a larger shift from radical to partial nephrectomies, leading to patients with improved renal functions after lesion resection.

The primary objective is to assess the ability to achieve preoperatively planned resection volumes by adding EM tracked navigation in RAPN, as minimizing the removal of healthy kidney tissue is challenging nowadays. A deviation within 35% between the planned and actual resection volumes is considered comparable and therefore deemed successful. Secondary objectives are the time for localizing and removing the renal lesion, the impact on surgical decisiveness, and the clinical and technical success of implementing the navigation setup.

Conditions

Renal Cancer; Partial Nephrectomy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients scheduled for robot-assisted partial nephrectomy

This study is designed as a single-center prospective feasibility study to evaluate the precision of EM tracking navigation in RAPN. We plan to conduct this study over a period of approximately 1 year. Eligible participants are patients who are scheduled for RAPN at the NKI-AvL, without restrictions on the pathology type of the lesions targeted for removal. Patients are informed about the study before the planned surgery and, after being provided with the necessary information regarding participation in the study, will be asked for informed consent. Participation in the study concludes at the end of the surgical procedure.

Group Type: EXPERIMENTAL

Image guided surgery

Intervention Type: PROCEDURE

Diagnostic CT and MRI scans are used to create a 3D digital model to illustrate the lesion's relation to the kidney and surrounding anatomy. The surgeon reviews this model, validates the segmentation, and plans the resection volume. The surgical procedure proceeds according to standard protocols in a standard operational setting, with the addition of navigation tools. A sterile EM sensor is inserted through a separate 5mm trocar and affixed to the kidney in proximity to the lesion in a region intended to be resected. Registration of the 3D model is conducted using an EM pointer or a tracked instrument, pointing to identifiable anatomical landmarks or structures on the kidney to validate accuracy. Both the digital model and the location of tracked instruments are displayed in real-time to the surgeon in the video console of the robot, allowing real-time navigation.

Interventions

Image guided surgery

Diagnostic CT and MRI scans are used to create a 3D digital model to illustrate the lesion's relation to the kidney and surrounding anatomy. The surgeon reviews this model, validates the segmentation, and plans the resection volume. The surgical procedure proceeds according to standard protocols in a standard operational setting, with the addition of navigation tools. A sterile EM sensor is inserted through a separate 5mm trocar and affixed to the kidney in proximity to the lesion in a region intended to be resected. Registration of the 3D model is conducted using an EM pointer or a tracked instrument, pointing to identifiable anatomical landmarks or structures on the kidney to validate accuracy. Both the digital model and the location of tracked instruments are displayed in real-time to the surgeon in the video console of the robot, allowing real-time navigation.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Patient provides written informed consent form
• Patient is scheduled for robot-assisted partial nephrectomy

Exclusion Criteria

• Ferro-magnetic implants or other factors in the abdominal or thoracic area that could influence image quality
• Pacemaker or defibrillator

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Netherlands Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theo Ruers

Role: PRINCIPAL_INVESTIGATOR

The Netherlands Cancer Institute

Locations

Netherlands Cancer Institute

Amsterdam, North Holland, Netherlands

Countries

Netherlands

Other Identifiers

N24NPN

Identifier Type: -

Identifier Source: org_study_id