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Clinical Trials/NCT05637359
NCT05637359
Completed
Not Applicable

Tracked Ultrasound for Patient Registration in Surgical Navigation During Abdominal Cancer Surgery

The Netherlands Cancer Institute1 site in 1 country26 target enrollmentJuly 13, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Abdominal Cancer
Sponsor
The Netherlands Cancer Institute
Enrollment
26
Locations
1
Primary Endpoint
Accuracy of tracked ultrasound registration.
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The goal of this observational pilot study is to evaluate the feasibility and accuracy of tracked ultrasound registration on patients undergoing abdominal cancer navigation surgery. The main research question is: Could tracked ultrasound be applied as an alternative to standard CBCT scanning in surgical navigation? Participants will undergo tracked ultrasound measurements of the pelvic bone on the operating room after patient anesthesia and before surgical incision.

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. Currently, registration is done by Cone-Beam CT (CBCT) scanning on the operating room (OR) prior to navigation surgery. However, standard CBCT scanning has several limitations, mainly limited availability on the hybrid OR and radiation exposure. Furthermore, standard CBCT scanning can only be performed in horizontal patient position, while the patient position mostly differs during surgery, such as the Trendelenburg position. The use of tracked ultrasound instead of standard CBCT could overcome these limitations, which might lead to an increased navigation accuracy and improved surgical outcomes. Therefore, the goal of this research is to evaluate the feasibility and accuracy of tracked ultrasound registration on patients undergoing abdominal cancer navigation surgery. The main research question is: Could tracked ultrasound be applied as an alternative to standard CBCT scanning in surgical navigation?

Registry
clinicaltrials.gov
Start Date
July 13, 2020
End Date
December 14, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients scheduled for tumor surgery in the abdominal/pelvic area and navigation surgery with a scheduled CBCT-scan in the OR
  • Patients provide written 'informed consent'

Exclusion Criteria

  • No exclusion criteria

Outcomes

Primary Outcomes

Accuracy of tracked ultrasound registration.

Time Frame: One day

To evaluate the accuracy of tracked ultrasound registration on patients undergoing abdominal cancer navigation surgery. This will be assessed using the target registration error in mm, where a lower error means a better outcome.

Secondary Outcomes

  • Influence of patient position alteration on registration accuracy.(One day)
  • Measurement time of tracked ultrasound registration.(One day)

Study Sites (1)

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