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van CCT (UK)

van CCT (UK)

Tracking of liver metastases during surgery

- candidate number28534
- NTR NumberNTR7019
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-feb-2018
- Secondary IDsNL56647.031.16 CCMO / N16LNA METC
- Public TitleTracking of liver metastases during surgery
- Scientific TitleTracking of liver metastases during surgery
- ACRONYMNL56647.031.16 / N16LNA
- hypothesisImage-guided navigation surgery allows the optimal use and full integration of pre-operative images during surgical procedure, and has the potential of reducing both irradical resections and morbidity. This pilot study investigates the potential of this new technique in liver surgery.
The objective of this feasibility study is to evaluate the accuracy of an in‐house developed electromagnetic navigation system to determine the distance from the resection margin to tumor tissue during liver surgery.
- Healt Condition(s) or Problem(s) studiedOpen liver surgery, Resection margins, Metastatic liver tumors
- Inclusion criteriaThe study population exists of patients scheduled for surgery of liver metastases from any origin. In order to be eligible to participate in this study, a subject must meet all of the following criteria:
 Age ≥ 18
 Liver metastases less than 3 cm under the liver surface
 Patients Provide written ‘informed consent’
 Patients should be suitable for iodinated contrast enhanced CT scanning (GFR>60 and no known allergies to iodinated contrast agents)
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study:
 Metal implants in the abdominal or thorax area that could influence EM tracking or other influences that would influence the EM field.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mei-2016
- planned closingdate1-mei-2018
- Target number of participants53
- InterventionsOn the day of surgery, three reusable electromagnetic (EM) patient trackers are placed on the back of the patient. Additionally, a single 6 degrees of freedom EM reference-marker and three surgical clips are attached to the liver with medical glue in close proximity to the tumor, but within the area that is planned to be removed by a surgery. This reference‐marker, which is placed at the start of the surgical procedure, will be used as a beacon for the EM navigation procedure, while surgical clips will be utilized for system’s accuracy verification. To subsequently correlate the precise position of the beacon to the pre-operative diagnostic CT or MR images, an intra‐operative contrast enhanced breath hold XperCT scan will be acquired once the beacon is in place. The images from this XperCT will be fused with the pre-operative diagnostic CT/MR which allows us to exactly visualize the position of the beacon on the diagnostic pre-operative CT scan.
During the following surgical procedure, anatomical structures and metastatic lesions can be identified using a blunt EM guidance probe of the electromagnetic navigation system. The accuracy of the EM system will be determined by measuring at several spots on the resection plane the distance from the resection plane to tumor tissue. These measurements will afterwards be correlated to corresponding distances in intraoperative XperCT image, which will be considered as a “gold” standard. Total time of the proposed intra-operative scan, including the planned accuracy measurements of the EM system, will take no longer than 30 minutes. Subsequent resection of the liver tumor will be performed according to standard surgical techniques. This is a feasibility study to evaluate the overall performance and accuracy of the surgical navigation system during surgery, without any impact on the surgical procedure itself.
- Primary outcomeThe main study endpoint is the accuracy of the EM navigation system to measure the distance from the EM probe (or tumor resection margin) to tumor tissue. In addition we will evaluate the handling of the navigation system during liver surgery.
- Secondary outcomeIntuitiveness of the navigation system: this will be evaluated by standardized utility questionnaires.
The outcome will be a quantitative value of the intuitiveness of this device which we can compare with other device trials.
- TimepointsN/A
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
- Funding
(Source(s) of Monetary or Material Support)
The Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital
- Publications
- Brief summaryImage-guided navigation surgery allows for full utilization of pre-operative imaging during surgery, and has the potential of reducing both irradical resections and morbidity. This is in liver surgery the first pilot study towards clinical implementation.
- Main changes (audit trail)
- RECORD6-feb-2018 - 23-feb-2018

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