Background: The purpose of this study was to evaluate safety and efficacy of a radiofrequency ablation system in clinical practice.
Methods: In 35 patients (age 63,9 +/- 12,6 years, range 22 - 83) a total of 65 liver tumors were percutaneously treated using a 200 watt radiofrequency generator and a LeVeen 4 cm array probe (RF3000, Boston Scientific). The interventions were performed under CT guidance in local anaesthesia and sedation. Adapted to the tumor size, the LeVeen Probe was repositioned during the procedure with an additional safety margin of 1 cm. Primary tumors were colorectal in 22, and mamma tumors (n = 4), zystic pancreas tumors (n = 2), gastric cancer (n = 1), zystadenocarcinoma of the liver (n = 1), lung cancer (n = 1), gastrointestinal stroma tumor (n = 1), duodenal carcinoma (n = 1), cholangiocellular carcinoma (n = 1) and hepatocellular carcinoma (n = 1). Post interventional control and follow-up was performed with multislice-CT (collimation 2.5 mm, unenhanced and contrast enhanced, arterial and portal filling) at 4 weeks, and every three months.
Results: One to 4 metastases were treated per patient during one or up to 4 procedure sessions. Mean lesion size was 2,3 +/- 1,2 cm (range 0,2 to 7,0). The corresponding size of the necrosis achieved was 4,6 +/- 1,4 cm (range 2,0 - 8,2). Primary technical success with complete tumor ablation was reached in 60 of 65 lesions. In 4 cases two treatment sessions were necessary in order to achieve the intended results. In one case the procedure was aborted because of a close relationship between lesion and right colon. 63 tumors were treated in sedation and local anesthesia. General anesthesia was necessary in two cases, in one who refused intervention in sedation, and in another case with insufficient analgetic effect. Morbidity was 9.2 %: Bleeding complications (n = 3, one arterial bleeding from the ablation tract, two intrahepatic bleedings with extrahepatic hematoma) were confirmed by selective angiography of the hepatic artery and were treated with coil embolisation of the respective segmental arteries. One case with subcapsular tumor ablation suffered from a large subcapsular hematoma requiring a blood transfusion. In one case with a subphrenic location of the metastasis, the needle electrode had passed the costophrenic recessus and resulted in an hematothorax. This patient was treated by pleural drainage for two days. One patient suffered from fever up to 39 degrees C and inflammation of the biliary tract and received a cholecystectomy 22 days post interventionally. There was no peri interventional mortality. Mean follow-up is 5,6 +/- 3,3 months (range 0 to 13). 21 of 35 patients showed no evidence of tumor recurrence. One case is scheduled for a second treatment session for complete tumor ablation. 13 of 35 patients suffered from tumor recurrence, either local recurrences and/or new metastases. At the sites of prior RF-ablation 9 local recurrences were detected in 7 patients, two cases with isolated local recurrences and 5 cases with local recurrences and new metastases. 6 Patients showed no evidence for local recurrences but new metastases. In these 11 cases a total of 37 metastases were found at new locations. In three patients tumor recurrence was treated by means of a second RF-ablation. The remaining 10 patients received chemotherapy.
Conclusion: RF-ablation can be performed in local anaesthesia and sedation with low peri interventional morbidity and mortality. Using the LeVeen probe and a 200 watt generator, appropriate necroses can be achieved. CT follow-up is required every three months because of the tumor recurrence rate and reinterventions may be required.