Clinical trial NCT05637359: Tracked Ultrasound for Patient Registration in Surgical Navigation During Abdominal Cancer Surgery
Official title: Tracked Ultrasound for Patient Registration in Surgical Navigation During Abdominal Cancer Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Cancer
Keywords: Surgical Navigation
Ultrasound
Registration
Electromagnetic Tracking
Pelvic Malignancies
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with cancer in the pelvic-abdominal area, who are scheduled for surgical resection of the malignant tissue in combination with the surgical navigation technique.

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?

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* 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

Primary outcomes:
measure: Accuracy of tracked ultrasound registration.
timeFrame: One day
Secondary outcomes:
measure: Influence of patient position alteration on registration accuracy.
timeFrame: One day
measure: Measurement time of tracked ultrasound registration.
timeFrame: One day
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute
state: North Holland
Study officials:
affiliation: NKI
name: Theo Ruers, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: