Image-guided Navigation During Robotic Sentinel Node Removal

Not Applicable

Recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT06091072
• Lead Sponsor: The Netherlands Cancer Institute

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2021-07-01
• Status Verified: 2023-10
• Study First Submitted: 2023-10-13
• Study First Submitted QC: 2023-10-13
• Last Update Submitted: 2023-10-13
• Study First Posted: 2023-10-19
• Last Update Posted: 2023-10-19
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of image-guide assisted sentinel node removal	One day	The percentage of successful image-guide assisted sentinel nodes removed, in which failure is defined as sentinel nodes which are per-operatively incorrectly identified as target SN by the navigation.

Secondary Outcome Measures

Name	Time	Method
Usability of image-guided navigation	One day	Evaluation of the usability of the image-guided navigation will be evaluated using the system usability scale (SUS). This scale ranges from 0-100 where a higher score means a better outcome.
Time	One day	Time to localization and removal of the sentinel node and total surgical time will be recorded.

Trial Locations

Locations (1)

Netherlands Cancer Institute; 🇳🇱 Amsterdam, North Holland, Netherlands