Navigated Laparoscopic Microwave Ablation of Tumor Mimics in Pig Liver - an Ex-vivo Trial

Study Overview
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Brief Summary
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In primary and secondary liver tumors microwave ablation could be an alternative to surgical resection.It could be performed laparoscopically. Under ultrasound control the microwave device is placed in the tumor.Therefore spatial orientation is challenging: the tumor is often missed and the failure rate is high. During learning curve this could lead to incomplete tumor ablation and high rate of local recurrence. Targeting systems could optimize that. The CasOne-SPOT-system is an innovative electromagnetic tracking and navigation system for laparoscopic microwave ablation. In this study targeting precision using the SPOT-System should be compared to conventional laparoscopic ultrasound-guided microwave ablation. Therefore tumor mimics (1-2cm) will be created in ex-vivo pig livers and microwave ablation will be performed ultrasound guided or ultrasound navigated. The ablation procedures will be performed by two novices and two experienced surgeons. Aim of this trial is to is to evaluate, if laparoscopic microwave ablation could be facilitated by the use of the SPOT-navigation system.

Official Title
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Navigated Laparoscopic Microwave Ablation of Tumor Mimics in Pig Liver - an Ex-vivo Single Center Trial

Conditions
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Liver Cancer, Surgery, Navigation, Spatial

Intervention / Treatment
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* Procedure: navigated microwave ablation
* Procedure: ultrasound guided navigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: board certified surgeon with experienced liver surgery with/ without experience in laparoscopic microwave ablation Exclusion Criteria: non
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: navigated microwave ablation<br>microwave ablation is performed laparoscopically with navigation | Procedure: navigated microwave ablation<br>* the laparoscopic microwave ablation in the pig liver is performed with the CasOne-Spot system<br>|
| Active Comparator: ultrasound guided microwave ablation<br>microwave ablation is performed laparoscopically with ultrasound guidance | Procedure: ultrasound guided navigation<br>* the laparoscopic microwave ablation iin the pic liver is performed with ultrasound guidance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to complete ablation | time from beginning of the targeting process until to complete ablation of the tumor mimic | 0-10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ablation completeness | the tumor in relation to the ablation figure is measures and the and and the completeness of the microwave ablation is evaluated | up to 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopy, navigation, microwave ablation, ultrasound guidance