Pilot study for a new bipolar radiofrequency ablation/aspirator device in the management of primary and secondary liver cancers.
BACKGROUND
In the US, the thermal ablation workload for cancer involving the liver is predicted to more than double in the next 5 years, emphasising the need to develop and improve the current technology.


METHODS
A multicentre nonrandomised prospective clinical trial (NCT00514930) was undertaken, to assess the efficacy and safety of a new bipolar radiofrequency ablation/aspirator device, in the treatment of primary and secondary cancers of the liver.


RESULTS
A total of 34 lesions in 16 patients were ablated at laparotomy and followed up at 4 weeks. The mean diameter of lesion before ablation was 3.2+/-2.22 (range 1-10) cm, the mean volume aspirated during ablation was 9.25+/-7.3 (range 0-25) ml and the mean operative time was 145.95+/-40.7 (range 60-215) min. There was one major complication of a pleural effusion, which required drainage. The mean length of stay was 8+/-3.2 (range 3-14) days. In 11 patients, the ablated tumour was resected. On histological assessment, there was no evidence of viable cancer at the tumour edge. On follow-up computed tomography, the ablation zone fully encompassed the targeted tumour and there were no local complications related to ablation.


CONCLUSIONS
Initial analysis of the data from this small cohort, with only a short-term follow-up, shows this device to be safe and effective.
Zacharoulis
Dimitris
D
Department of Surgery, University Hospital of Larissa, Larissa, Greece.
Khorsandi
Shirin E
SE
Vavra
Petr
P
Dostalik
Jan
J
Navarra
Giuseppe
G
Nicholls
Joanna P
JP
Jiao
Long R
LR
Habib
Nagy A
NA
D017115:Catheter Ablation / Q000295:instrumentation* / Q000379:methods*; D005260:Female; D006651:Histocytochemistry; D006801:Humans; D007813:Laparotomy / Q000379:methods; D008113:Liver Neoplasms / Q000601:surgery*; D008297:Male; D010865:Pilot Projects; D011446:Prospective Studies; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome