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

Not Applicable

Completed

• Conditions: Liver Cancer; Surgery; Navigation, Spatial
• Interventions: Procedure: navigated microwave ablation; Procedure: ultrasound guided navigation

• Registration Number: NCT04106453
• Lead Sponsor: Universitätsklinikum Köln

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-14
• Study First Submitted: 2019-09-24
• Study First Submitted QC: 2019-09-25
• Study First Posted: 2019-09-27
• Primary Completion: 2020-01-14
• Status Verified: 2020-02
• Study Completion: 2020-02-04
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

board certified surgeon with experienced liver surgery with/ without experience in laparoscopic microwave ablation

Exclusion Criteria

• non

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
navigated microwave ablation	navigated microwave ablation	microwave ablation is performed laparoscopically with navigation
ultrasound guided microwave ablation	ultrasound guided navigation	microwave ablation is performed laparoscopically with ultrasound guidance

Primary Outcome Measures

Name	Time	Method
time to complete ablation	0-10 minutes	time from beginning of the targeting process until to complete ablation of the tumor mimic

Secondary Outcome Measures

Name	Time	Method
ablation completeness	up to 1 day	the tumor in relation to the ablation figure is measures and the and and the completeness of the microwave ablation is evaluated

Trial Locations

Locations (1)

University of Cologne, Department of General, Visceral and Cancer Surgery; 🇩🇪 Cologne, Germany