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Vascular and Interventional Radiology |
1 From the Departments of Diagnostic Imaging and Nuclear Medicine (T.S., Y.M., F.A., K.I., J.K.) and Gastroenterological Surgery (Y.I., Y.Y.), Kyoto University Graduate School of Medicine, 54-Kawaharacho, Shogoin, Sakyoku, Kyoto 606-8507, Japan. Received April 16, 2001; revision requested May 11; revision received July 24; accepted September 7. Address correspondence to T.S. (e-mail: ksj@kuhp.kyoto-u.ac.jp).
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONMATERIALS AND METHODS RESULTSDISCUSSIONREFERENCES |
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MATERIALS AND METHODS: Seventy-two patients with 94 HCC nodules were randomly assigned to RF ablation and PMC groups. Thirty-six patients with 48 nodules were treated with RF ablation, and 36 patients with 46 nodules were treated with PMC. Therapeutic effect, residual foci of untreated disease, and complications of RF ablation and PMC were prospectively evaluated with statistical analyses.
RESULTS: The number of treatment sessions per nodule was significantly lower in the RF ablation group than in the PMC group (1.1 vs 2.4; P < .001). Complete therapeutic effect was achieved in 46 (96%) of 48 nodules treated with RF ablation and in 41 (89%) of 46 nodules treated with PMC (P = .26). Major complications occurred in one patient treated with RF ablation and in four patients treated with PMC (P = .36). During follow-up (range, 6–27 months), residual foci of untreated disease were seen in four of 48 nodules treated with RF ablation and in eight of 46 nodules treated with PMC. No significant difference in rates of residual foci of untreated disease was noted (P = .20, log-rank test).
CONCLUSION: RF ablation and PMC thus far have had equivalent therapeutic effects, complication rates, and rates of residual foci of untreated disease. However, RF tumor ablation can be achieved with fewer sessions.
© RSNA, 2002
Index terms: Liver, CT, 761.1211, 761.12112, 761.12113, 761.12114, 761.12115 • Liver neoplasms, 761.323, 761.33 • Liver neoplasms, therapy, 761.1269 • Microwaves, 761.1269 • Radiofrequency (RF) ablation, 761.1269
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODS RESULTSDISCUSSIONREFERENCES |
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Percutaneous ethanol injection is the most widely performed local treatment for small HCCs (2–4). The prognosis of patients with HCCs less than or equal to 3 cm in diameter who are treated with percutaneous ethanol injection is comparable to that of patients who are treated with surgical resection (3,4). Several reports from Europe and the United States, however, have indicated that RF ablation is very effective for the local control of small HCCs (5,9–11). On the other hand, PMC has been used to treat HCC in Japan mainly (13–15), and there have been reports that PMC is superior to percutaneous ethanol injection for local control of small HCCs (16,17).
It appears that in the future, RF ablation and PMC might be alternative therapies to percutaneous ethanol injection. To our knowledge, there have been no studies to compare the effectiveness of RF ablation and PMC for local control of HCC. Thus, the purpose of our study was to evaluate the effectiveness of RF ablation and PMC in treating patients with HCC.
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MATERIALS AND METHODS |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODS RESULTSDISCUSSIONREFERENCES |
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The patients were told that RF ablation and PMC were expected to be equally effective for local control of HCC. Patients were assigned, with use of sealed envelopes, to the RF ablation group (n = 36) or the PMC group (n = 36). The clinical backgrounds of each treatment group are summarized in the Table. Of the 36 patients treated with RF ablation, 25 had a solitary nodule, 10 had two nodules, and one had three nodules; thus, a total of 48 nodules were treated in these patients. Of the 36 patients treated with PMC, 28 had a solitary nodule, six had two nodules, and two had three nodules; thus, a total of 46 nodules were treated in these patients.
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RF Ablation
One author (T.S.) performed the RF ablation and PMC procedures. A commercially available generator system (RF 2000; RadioTherapeutics, Mountain View, Calif) was used for RF ablation (10). This system consists of a generator, a monopolar-array needle electrode (LeVeen; RadioTherapeutics), and a dispersive electrode pad that is applied to the patient’s skin. The RF generator has a 460-kHz frequency and displays that indicate the tissue impedance value and procedural time. The needle electrode is a 15-gauge insulated cannula with eight or 10 hook-shaped expandable electrode tines with a diameter of 2.0, 3.0, or 3.5 cm at expansion. In the normal liver of a beagle, the mean diameter of tissue ablation achieved by using this electrode with 2.0-, 3.0-, or 3.5-cm expanded tines is approximately 3.0 x 2.2 cm, 3.5 x 2.8 cm, or 4.0 x 3.3 cm, respectively (T.S., Y.Y., unpublished data, 1999). For nodules up to 1.5 cm in diameter, mainly an electrode with 2.0-cm expanded tines was used; for nodules 1.5–2.5 cm in diameter, an electrode with 3.0-cm expanded tines; and for nodules larger than 2.5 cm in diameter, an electrode with 3.5-cm expanded tines.
Grounding was achieved by means of attaching a dispersive pad to each of the patient’s thighs. Pentazocine (15 mg) (Sosegone; Yamanouchi Pharmaceutical, Tokyo, Japan) was intramuscularly injected 10 minutes before therapy as a premedication for sedation. After the skin surface was disinfected and local anesthesia was induced with 1% lidocaine, a 15-gauge RF probe with 2.0- or 3.0-cm expanded tines, which was connected to the RF generator with a soft cable, was introduced into the center of the nodule with US guidance. The hooks were then deployed in situ in the nodule. With use of an electrode with 2.0-cm expanded tines, treatment was initiated with 30 W of power and increased 10 W/min to 60 W. RF energy was applied until either marked increases in impedance (ie, precipitous decreases in power output as tissue impedance increases markedly owing to coagulation necrosis) were achieved or 15 minutes had elapsed. The second treatment was then applied at the same position until either marked increases in impedance were achieved or 10 minutes had elapsed at 45 W.
With use of an electrode with 3.0-cm expanded tines, an initial power of 40 W was applied and increased 10 W/min to 75 W. RF energy was applied until either marked increases in impedance were achieved or 15 minutes had elapsed. The second treatment was then applied at the same position until either marked increases in impedance were achieved or 10 minutes had elapsed at 55 W. An RF probe with 3.5-cm expanded tines was introduced into a 0.5–1.0-cm–deep position from the center of the nodule. Treatment was then initiated at 50 W and increased 10 W/min to 90 W. RF energy was applied until either marked increases in impedance were achieved or 15 minutes had elapsed. Then, after the withdrawal of the electrode 1.0–1.5 cm from the first position, the second treatment was initiated at 50 W and increased 10 W/min to 90 W. RF energy was applied until either marked increases in impedance were achieved or 15 minutes had elapsed. Patients who experienced severe pain during or immediately after the treatment received pentazocine (15 mg) intravenously.
PMC Therapy
The microwave delivery system (Microtaze; Nippon Shoji, Osaka, Japan) consists of a microwave generator, which emits a 2,450-MHz microwave, and a microwave electrode 1.6 mm in diameter and 25 cm in length (13,14). The microwave electrode was connected to the microwave generator by a soft coaxial cable. Pentazocine (15 mg) was intramuscularly injected 10 minutes before therapy as a premedication for sedation. After the skin surface was disinfected and local anesthesia was induced with 1% lidocaine, a 14-gauge guide needle (PMCT NSP; Hakko, Tokyo, Japan) was introduced with US guidance. In the normal liver of a rabbit, the mean diameter of tissue coagulation achieved with a 1.6-mm microwave electrode is about 2.4 x 1.6 cm (13). For nodules less than or equal to 2.0 cm in diameter, a guide needle was introduced into the center of the nodule, and then the inner needle was removed.
Through the outer guiding needle, the electrode was introduced at 5 mm beyond the deep margin of the nodule, and coagulation therapy was performed with a single treatment of 70-W output for 60 seconds. To coagulate an area sufficiently, the electrode was withdrawn every 10 mm to repeat the treatment at 5 mm beyond the superficial margin of the nodule. The electrode and the outer guiding needle were then removed, and the needle track was coagulated with microwaves to prevent bleeding from the liver surface. To coagulate a large area for nodules greater than 2.0 cm in diameter, two to three guide needles were introduced with US guidance in a manner that facilitated optimal thermal coagulation of the entire tumor volume. Then, an electrode was inserted through each outer guiding needle, and multiple treatments were performed in a single session with the procedure just described. Patients who experienced severe pain during or immediately after the treatment received 15 mg of pentazocine lactate intravenously.
Effectiveness of RF Ablation and PMC
All treatment sessions were completed within 1 month after the beginning of the therapies. Dynamic CT was performed 1 week and 1 month after the initial treatments. The CT scans were interpreted by one author (Y.M.). When a nonenhancing area with a diameter equal to or greater than that of the treated nodule was detected, tumor necrosis was considered to be complete. When nodule enhancement was seen at dynamic CT, tumor necrosis was considered to be incomplete. Additional RF ablation or PMC treatments were performed in nodules that showed incomplete necrosis at dynamic CT performed 1 week after the initial treatment. The therapeutic effect of the therapy was evaluated with dynamic CT 1 month after the initial treatment, and when no enhancing lesion was seen, the therapeutic effect was considered to be complete. When nodule enhancement was still seen, the therapeutic effect was considered to be incomplete.
The number of treatment sessions per nodule was compared between the RF ablation and PMC groups. The time required for the ablation therapy, which was defined as the time from skin disinfection to electrode withdrawal, was compared between the RF ablation and PMC groups.
Follow-up dynamic CT was performed every 2 months. A newly appearing enhancing lesion in or near the treated nodule or an enlargement of the treated nodule was considered to be residual foci of untreated disease. The follow-up periods ranged from 6 to 27 months (mean, 18 months).
Complications
Major complications, such as hemorrhage, cholangitis (ie, biloma), liver abscess, hepatic infarction, skin burn, pneumothorax, and tumor dissemination, were assessed by two authors (Y.I., Y.Y.). Complete blood cell counts, platelet counts, coagulation profiles, and liver function tests (eg, for aspartate transaminase, alanine transaminase, alkaline phosphatase, 
-glutamyl transpeptidase, and total bilirubin levels) were performed 1, 3, and 7 days after the therapy.
Statistical Analyses
The variables in the RF ablation and PMC groups were compared. For qualitative variables, 
2 analysis or the Fisher exact probability test was performed. For continuous variables, the Student t test or Mann-Whitney test was applied. The rates of residual foci of untreated disease from the time of diagnosis of HCC were calculated by using the Kaplan-Meier method. We compared the rate of residual foci of untreated disease in the RF ablation group with this rate in the PMC group by performing the log-rank test. A P value of less than .05 was considered to indicate a statistically significant difference.
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RESULTS |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODS RESULTSDISCUSSIONREFERENCES |
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-fetoprotein levels (2 test), Child-Pugh cirrhosis class or number of lesions (Mann-Whitney test), or proportion of patients with positive antibody against hepatitis C virus or proportion of patients with positive hepatitis B surface antigen (Fisher exact probability test) (Table).
Therapeutic Effect, Number of Sessions, Time Required for Therapy, and Local Recurrence
In the RF ablation group of 36 patients, one to three ablation sessions per nodule were performed, and a total of 55 sessions (mean ± SD, 1.1 treatments ± 0.46) were performed in the 48 nodules. A single treatment session was performed in 43 (90%) of 48 nodules, two sessions were performed in three (6%) nodules, and three sessions were performed in two (4%) nodules. The mean time required for RF ablation therapy was 53 minutes ± 16 per session. Intravenous administration of an analgesic was needed during or immediately after treatment in 10 sessions performed in 10 patients. Of 48 nodules, 46 (96%) showed complete therapeutic effect (Fig 1) and two (4%) had residual lesions, or incomplete therapeutic effect. All 23 nodules less than or equal to 2.0 cm in diameter showed complete therapeutic effect. The two nodules with incomplete therapeutic effect, which had diameters of 2.4 and 3.0 cm, were near the hepatic veins (Fig 2). During follow-up, residual foci of untreated disease were seen in four nodules (8%).
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In the PMC group, liver abscess occurred with one treatment session performed in one patient, cholangitis with intrahepatic bile duct dilatation occurred with one treatment session performed in one patient, subcutaneous abscess with skin burn occurred in one treatment session performed in one patient, and subcapsular hematoma occurred in one treatment session performed in one patient. A catheter was placed percutaneously for drainage in the patient with liver abscess. The patient with cholangitis recovered following the administration of antibiotics. In the patient with a subcutaneous abscess and skin burn, the abscess was drained by means of skin incision. Conservative management was used for the subcapsular hematoma: It was allowed to absorb without medical intervention such as blood transfusion or transcatheter arterial embolization.
No life-threatening complications were observed. In most of the patients without major complications, serum liver enzyme levels increased 1 day after therapy but returned to normal by 7 days after treatment.
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DISCUSSION |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODS RESULTSDISCUSSIONREFERENCES |
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In our study, complete therapeutic effect was achieved in 42 nodules less than or equal to 2.0 cm in diameter: 23 nodules treated with RF ablation and 19 nodules treated with PMC. Thus, RF ablation and PMC may produce sufficient ablation of the tumor and the surrounding liver parenchyma and could become the main treatment for HCCs less than or equal to 2 cm in diameter and the main treatment alternative to percutaneous ethanol injection.
Because the coagulated area produced by PMC is smaller than the area produced by RF ablation, more PMC sessions were required to produce complete nodule necrosis (mean number of sessions for PMC vs RF ablation, 2.4 vs 1.1; P < .001). Multiple coagulation therapy sessions led to a prolonged treatment course. Three nodules larger than 3 cm in diameter that were treated with PMC showed incomplete therapeutic effect. Although there was no significant difference in the rate of complete therapeutic effect between the RF ablation and PMC groups (96% vs 89%), we believe that RF ablation would be preferable for the treatment of medium-sized nodules—that is, those larger than 2 cm in diameter.
A common disadvantage of both RF ablation and PMC is the reduced area of coagulation or ablation produced by the cooling effect of hepatic blood flow (23,24). Two nodules treated with RF ablation and one nodule treated with PMC near a hepatic vein or portal vein showed incomplete therapeutic effect, presumably because of the cooling effect. Thus, ablation therapy performed during interrupted hepatic blood flow with balloon occlusion of the hepatic artery and hepatic vein is another treatment option (23,24). This technique is more invasive, however, because the ablation must be performed during angiography. In such cases, RF ablation followed by percutaneous ethanol injection should be effective, because the size of the area ablated with ethanol is not affected by the cooling effect.
Three types of RF electrodes are currently available commercially: two brands of retractable needle electrodes (model 70 and model 90 Starburst XL needles, RITA Medical Systems, Mountain View, Calif; LeVeen needle electrode, RadioTherapeutics) and an internally cooled electrode (Cool-Tip RF electrode; Radionics, Burlington, Mass) (25,26). de Baere et al (27) found that the internally cooled electrode produced substantially larger lesions than did the expandable needle in animal livers. However, to our knowledge, there are no reports of comparisons of the effectiveness of these RF electrodes in human studies. The rate of complete necrosis of HCC treated with internally cooled electrodes has been reported to be 90% (47 of 52 nodules) (11), and the rates of residual foci of untreated disease treated by using Starburst XL needle electrodes has been reported to be 4% (one of 24 nodules) (9). Our results with the Leveen needle electrode (rate of complete therapeutic effect, 96% [46 of 48 nodules]; rates of residual foci of untreated disease, 4% at 1 year and 12% at 2 years) were equivalent. Also, our rates of residual foci of untreated disease were equal to or better than the rates of foci treated with percutaneous ethanol injection (10.5%–26.0%) (4,20–22).
There was no significant difference in the rate of major complications between the RF ablation and PMC groups. In the PMC group, four patients had one of the following complications: liver abscess, cholangitis, bile duct dilatation, or subcutaneous abscess with skin burn. Multiple microwave treatments might increase the risk of damage to the biliary tract and/or cause infection. The microwave electrode consists of inner and outer conductors. For heat and electric insulation, the space between these two conductors is filled with silicon gum and polytetrafluorethylene (13), but the insulation for heat may not be complete. The incomplete insulation of a microwave electrode may induce skin burn.
Both RF ablation and PMC are currently undergoing major modifications, so the new techniques may produce larger areas of tumor coagulation or ablation in the future. In conclusion, the current RF ablation and PMC techniques thus far have had equivalent therapeutic effectiveness, complication rates, and rates of residual foci of untreated disease; however, RF ablation offers the advantage of tumor ablation achieved in fewer sessions. We prefer RF ablation over PMC for the treatment of small HCCs.
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FOOTNOTES |
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Abbreviations: HCC = hepatocellular carcinoma, PMC = percutaneous microwave coagulation, RF = radio frequency
Author contributions: Guarantors of integrity of entire study, all authors; study concepts and design, T.S., Y.I., Y.Y.; literature research, T.S., Y.M., F.A.; clinical studies, T.S., Y.Y., Y.I., Y.M., K.I.; data acquisition, all authors; data analysis/interpretation, T.S., Y.I., Y.Y.; statistical analysis, T.S., Y.M., F.A.; manuscript preparation, T.S.; manuscript definition of intellectual content, T.S., Y.M., F.A., K.I.; manuscript editing, T.S., K.I., J.K.; manuscript revision/review and final version approval, all authors.
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REFERENCES |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODS RESULTSDISCUSSIONREFERENCES |
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