Navigated Partial Nephrectomy

Netherlands Cancer Institute (NKI)

Status: Completed

Conditions: Partial Nephrectomy; Renal Cancer

Treatments: Procedure: Image guided surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT07315100

N24NPN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Patients scheduled for robot-assisted partial nephrectomy

Experimental group

Description:

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.

Treatment:

Procedure: Image guided surgery