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

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Cancer
• Intervention / Treatment: Device: Tracked ultrasound measurement

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?

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• Netherlands
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1066 CX
      • Netherlands Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients scheduled for navigated abdominal cancer surgery; Patients are 18 years old or older. Patients are scheduled for tumor surgery in the abdominal/pelvic area and navigation surgery with a scheduled Cone Beam CT-scan in the operating room. Patients provide written 'informed consent'. The to be administered intervention is a percutaneous tracked ultrasound measurement of the patient's pelvic bone on the operating room after anesthesia.

Device: Tracked ultrasound measurement; Participation in the study will not involve additional visits to the hospital or additional CT scans for the included patients. For this experiment, 2D ultrasound images are obtained using an ultrasound transducer linked to the electromagnetic navigation system, which is already in place for the navigation at the operating room. After anesthesia and in parallel to the final preparations of the patient, two percutaneous ultrasound measurements of the pelvic bone are performed and recorded. The first measurements are performed in Trendelenburg patient position and the second measurements in supine patient position. When preparations are finished, normal workflow is continued, including the standard Cone Beam CT acquisition required for the navigation and sterile draping of the patient. The acquired ultrasound scans will be analyzed post-operatively and offline. This measurement has no impact on the (navigated) surgical procedure itself.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of tracked ultrasound registration.	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.	One day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influence of patient position alteration on registration accuracy.	What is the influence of patient position alteration on the surgical navigation accuracy for standard Cone Beam CT and tracked ultrasound registration methods? This will be assessed using the target registration discrepancy in mm.	One day
Measurement time of tracked ultrasound registration.	The time duration of ultrasound measurements will be recorded and compared with the conventional Cone Beam CT method. A faster ultrasound measurement time means a better outcome.	One day

Collaborators and Investigators

• Sponsor: The Netherlands Cancer Institute
• Investigators: Principal Investigator: Theo Ruers, prof. dr., NKI

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2020
• Primary Completion (Actual): December 14, 2021
• Study Completion (Actual): December 14, 2021

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: November 24, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): December 5, 2022
• Last Update Submitted That Met QC Criteria: November 24, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Ultrasound; Surgical Navigation; Registration; Electromagnetic Tracking; Pelvic Malignancies
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Abdominal Neoplasms
• Other Study ID Numbers: IRBd20-141

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No