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

NCT05637359 | Completed

• 1 other identifier: IRBd20-141
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Cancer

Keywords

Surgical Navigation; Ultrasound; Registration; Electromagnetic Tracking; Pelvic Malignancies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Influence of patient position alteration on registration accuracy.

  One day

• Measurement time of tracked ultrasound registration.

  One day

Study Arms (1)

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

Interventions

Tracked ultrasound measurement DEVICE

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.

Patients scheduled for navigated abdominal cancer surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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'

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead

Study Sites (1)

Netherlands Cancer Institute

Amsterdam, North Holland, 1066 CX, Netherlands

Location

Related Publications (1)

• Hiep MAJ, Heerink WJ, Groen HC, Ruers TJM. Feasibility of tracked ultrasound registration for pelvic-abdominal tumor navigation: a patient study. Int J Comput Assist Radiol Surg. 2023 Sep;18(9):1725-1734. doi: 10.1007/s11548-023-02937-8. Epub 2023 May 25.

  PMID: 37227572 DERIVED

Study Officials

• Theo Ruers, prof. dr.

  NKI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: December 5, 2022
• Study Start: July 13, 2020
• Primary Completion: December 14, 2021
• Study Completion: December 14, 2021
• Last Updated: December 5, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)