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

Universitätsklinikum Köln

Status: Completed

Conditions: Surgery; Navigation, Spatial; Liver Cancer

Treatments: Procedure: ultrasound guided navigation; Procedure: navigated microwave ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT04106453

19-392

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• non

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

navigated microwave ablation

Experimental group

Description:

microwave ablation is performed laparoscopically with navigation

Treatment:

Procedure: navigated microwave ablation

ultrasound guided microwave ablation

Active Comparator group

Description:

microwave ablation is performed laparoscopically with ultrasound guidance

Treatment:

Procedure: ultrasound guided navigation