Image-guided Navigation During Robotic Sentinel Node Removal (N21LND)

Netherlands Cancer Institute (NKI)

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Other: Image-guided navigation

Study type: Interventional

Funder types: Other

Identifiers

NCT06091072

NL77462.031.21

Details and patient eligibility

About

Image-guided navigation based on pre-operative imaging can give the surgeon more insight into the location of the sentinel nodes in relation to other anatomical structures. The purpose of the study is to investigate the feasibility of image-guided navigation during robot-assisted surgery to treat cancer in the pelvic area.Ultimately, the application of navigation during robot-assisted sentinel node dissection could potentially improve the outcome of surgery for the patient.

Full description

Image-guided navigation surgery allows for full utilization of pre-operative imaging during surgery, and has the potential of reducing both irradical resections and morbidity. It has successfully been applied in the AvL for open abdominal surgery, however more and more surgeries are being performed less invasive using robot surgery. Rapid extension of robot-assisted surgery has increased the need for robot-compliant image-guided techniques.

Unfortunately, tactile feedback is lacking in these robotic surgeries, which increases the additional value of image-guided navigation. In this study, patients will undergo an abdominal sentinel node dissection in order to evaluate the actual technical benefit of robotic navigation. This is the first feasibility study towards clinical implementation of the navigation setup into robot-assisted image-guided navigation surgery. The results of this study will be the base for new studies, evaluating the clinical benefit of image-guided navigation for robot surgeries.

Enrollment: 55 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Scheduled for abdominal robotic sentinel node resection
• ≥ 18 years old
• Provided written 'informed consent'
• Sentinel nodes should be fixed relative to retroperitoneal structures or major vessels.

Exclusion criteria

• Metal hip implants / implants in the pelvic area
• Pacemaker, defibrillator

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Patients scheduled for sentinel node procedure

Experimental group

Description:

This is a single-center observational feasibility study to evaluate the overall performance of the surgical navigation system during robotic surgery, without impact on the surgical procedure itself. The duration of this study will be approximately 2.5 years. Patients scheduled for a sentinel node procedure at the NKI are eligible for inclusion. 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. No additional risk is expected using the NDI navigation setup. Patients will receive some additional radiation due to the CT scan during surgery; a perioperative CBCT scan (\~ 4 mSv) is acquired. This extra dose is low, considering other standard imaging in these patients like, pre-operative imaging with SPECT/CT scans. After surgery, no further participation or cooperation of the patient is required.

Treatment:

Other: Image-guided navigation