Comparison between combination therapy of percutaneous ethanol injection and radiofrequency ablation

PO Box 2345, Beijing 100023,Chinawww魔World Journal of Gastroenterology ISSN 1007-9327wig@wigner corELSEVIERG2005 The WG Press and Elsevier Erc. All rights reserveComparison between combination therapy of percutaneousethanol injection and radiofrequency ablation and radiofrequencyablation alone for patients with hepatocellular carcinomaKazutaka Kurokohchi, Seishirm Watanabe, Tsutomu Masaki, Naoki Hosomi, Yoshiaki Miyauchi, Takashi Himoto, YasuhikoKimura, Seiji Nakai, Akihiro Deguchi, Hirohito Yoneyama, Shuhei Yoshida, Shigeki KuriyamaKazutaka Kurokohchi, Seishiro Watanabe, Tsutomu Masakl, Key words: Combination therapy; Percutaneous ethanolNaoki Hosomi, Yoshiaki Miyauchi, Takashi Himoto, Yasuhiko injection; Radiofrequency ablation; Energy requirementKimura, Seiji Nakai, Akihiro Deguchi, Hirohito Yoneyama,Shuhei Yoshida, Shigeki Kuriyama, Third Department of Intemal Kurokohchi K, Watanabe S, Masaki T, Hosomi N, Miyauchi Y,edicine Kagawa University School of Medicine, 1750-1 IkenobeMiki-cho, Kita-gun, Kagawa 761-0793, JapanHimoto T, Kimura Y, Nakai S, Deguchi A, Yoneyama H, YoshidaCorrespondence to: Shigeki Kuriyama, Third Departmcnt of S,Kuriyama S. Comparison between combination therapyInternal Medicine, Kagawa University School of Medicine, 1750-1 of percutaneous ethanol injection and radiofrequerIkenobe, Miki-cho, Kita-gun, Kagawa 761-079ablation and radiofrequency ablation alone for patients withJapan. skuriyam@med. kagawa-u ac jphepatocellular carcinoma. Wordd J Gastroentero/ 2005: 11Telephone:+81-878-91-2156Fax:+81-878-91-2158(10):1426-1432Received: 2004-08-17 Accepted: 2004-10-18http://www.wignet.com/1007-9327/11/1426.aspAbstracINTRODUCTIONtreatment were further elucidated by analyzing the Hepatocellular carcinoma (CO) is onc of the most seriousrelationship between the volume of coagulated necrosis problems worldwide. Although intcnsive efforts have beenand the energy requirement for ablation or the amountmade for the treatment of HCC, the mortality of patientsof ethanol injected into Hccwith HCC is still high. Tumor ablation technologies such asmicrowave, laser and radio frequency have been shown toMETHODS: The volume of coagulated necrosis, total bc reliable agd effective for inducing thermally-mediatedenergy requirement and energy requirement for coagulation necrosis for primary HCC- and metastaticcoagulation of per unit volume were examined in the liver cancer". Percutaneous ethanol injection(PED)therapygroups of PEI-RFA and rFa alone using the Cool-tip RF more frequently performed in the past, is considered to beeffective for the treatment of patients with relatively smallsized encapsulated HCC below 3 cm in the longest diameterRESULTS: The results showed that the volume of reccntly, it has become possible to obtain larger areas ofcoagulated necrosis induced was significantly larger in coagulated necrosis by the innovation of radiofrequencyPEI-RFA group than in routine RFA group, when the total (RFA)technologies Much effort has been applied toenergy administered was comparable in both groups. enhance the therapeutic effects of RFA by the combinationIn PEI-RFA, enlargement of coagulated necrosis was of RFA with other modalities. For example, combined useadmitted in 3 dimensions and the amount of energy of transcatheter arterial chemoembolization( -15) or salinerequirement per unit volume of coagulated necrosis was injection +i7 with RFA therapy was shown to be effectivenegatively correlated with the amount of ethanol injected to enhance the coagulated necrosis. We also developed anovel combination therapy of PEI and RFA (PEI-RFA)CONCLUSION: These results suggest that, compared and reported that this combination therapy could induceto RFA alone, PEI-RFA enables to induce comparable wider coagulated necrosis without much efforts and adversethat pEI-RFA is likely to be less invasive than RFA alone tumors tho, Chermore, this therapy can be applied to thecoagulated necrosis with smaller energy requirement, and effects. Ft八tra+ wwith rfa alone1irrespective of inducing enhanced coagulated necrosisFurt中国煤化工 t for inducing theThus, simple prior injection of ethanol may make RFA coagCNMHtreatment more effective and less invasive for the using blawny,"have reported thattreatment of patients with HCC.percutaneous ethanol and lipiodol injection therapy(PELIT), considered to be a milder therapy than RFA,was2005 The W]G Press and Elsevier Inc. All rights reserved. important as a supportive treatment modality for HCCsKurokohchi K et al. Energy requirement in PEI-RFA for HCC treatment1427especially for those lacking the vascularity or for patientswith severely impaired hepatic reserve and useful for thetreatment of hccs that were difficult to treat with rFaaloncl2n. After developing PEI.RFA treatment, we have欢experienced so far some cases that were satisfactorilytreated by use of relatively low-power output contreThus, in the present study, PEl-RFA treatment wasfurther characterized from the standpoint of the energyrequirement for total andunit volume ablation as wcll asof the amount of ethanol injected, using the RF systemcooIelectrodesFigure 1 Appearance of PEH-RFA treatment A 17-gauge RFMATERIALS AND METHODSinto the tumPatientsthe hole of the attachment beside the echo probe, and thenPEI needle was inserted through the same hole. RFa was ImPEI-RFA was performed against 75 cascs (5.3 males and immediately after Injecting theinto the tur22 females; mean age of 69 years)with biopsy-proven HCC. was performed unde r the impedance control, The amountThe patients were also diagnosed as having HCC by helical the estimated tumor volume and the injection of ethanol wasdynamic computed tomography(CT). Among the total if resistance to the injection was felt.ubjects, RFA alone was donc in 15 patients and PEl-RFAwas in 60. The characteristics of the subjects are shown inTable 1. All of these studies were conducted with informed Evaluation of therapeutic efficacyconsent at the time of the enrollment for this study.The efficacy of the RFa was assessed by using helicaldynamic contrast-enhanced CT five to seven days after theTable 1 Characteristics of patients enrolled in the present studytreatment. Tumor necrosis was considered to be complcteif no enhancing areas were obscrved based on imagesFA alonePEL-RFAobtained during early and late phases of dynamic contrastTotal number of patientMale/female10/545/15Age (yr)Evaluation of energy requirement for ablationMeanEnergy requirement needed for ablation was calculatedTumor size(cm)as follows: energy ()=Watt(W)x duration of ablationThe length of coagulated necrosis of the lesion was measured153.5from the late phase of helical dynamic CT. Approximationvolume of wholc coagulated necrosis area and cnergyrequirement for ablation per unit volume were calculatedChild-Pugh gradeas follows: whole coagulated volume(cm)=4/3X r(cm)xr(cm)xr(cm);(r'= longest diameter/2;r= shortestdiameter /2; r= height/2) and energy requirement forcoagulation per unit volume (/cm)=energy/wholecoagulated necrosis.PEI-RFA was performed under the real-time ultrasonographyStatistical analysisus)guidance with a 3.5-MHz sector probe(Power Vision Statistical analysis was performed using Macintosh software5000; Toshiba Medical, Tokyo, Japan). RFA was performed Star View II (Version 5.0). Regression analysis was used toby Cool-tip rF System(RADIONICS, Burlington, USA)2A calculate the correlation coefficients and P values. Statisticalaccording to the method described in our previous significance was accepted when p<0.05manuscripts. 9. Briefly, a 17-gauge RFA needle with anlectrode of 3 cm in length was first inserted into the tumor, RESULTSand then a 21-gauge PEI needle was inserted into the tumorin the liver through the same hole of the attachment beside Comparison of the volume of coagulated area, and energythe echo probe, and then pure cthanol was slowly injected requirement and the energy requirement for total and unitinto the tumor till the whole area of tumor was filled with volumthe ethanol(Figure 1). Ethanol injection into the tumor was Sevent中国煤化工形4aAa0eceased when resistance to the injection was felt. The volume OneCNMHGRFA, while the otherof injected ethanol was always kept below the double of (15 patients)KfA alone. All ot these patients underwentestimated tumor volume. The ablation was performed under RFA therapy by means of the Cool-tip RF system. No majorthe impedance control and the power output was increased complications or adverse effects were observed in bothstepwise and the ablation was terminated after the high groups. The volume of coagulated necrosis areas, the totalechoic shadow sufficiently covered the tumor margin.ment and the cnergy requi方数据1428 ISSN 1007-9327 CN 14-1219/R World J Gastroenterol March 14, 2005 Volume 11 Number 10of per unlt volume in the groups of PEH-RFA and RFA aosis, total energy requirement and the energy requirement for inducing coagulationTable 2 Comparlson of the volume of coagulated neEtoH(mL)Hfan)v(cm)T-ENE 0)T-ENE/V O/cm)A alone23±061±0665:3638700±1254910010±1112469±6642±1.235±1.04D±1,1340±29353828:28144235±1690≤00001<0.0001<0000100002c0.000073<0.0001sixty patients with HCC were treated with PEI-RFA by Cool-tip RF System, while 15 patients were treated with RFA alone using the same system. After the treatment,thet and shortest diameters and the height of the coagulateosis were estimated by the contrast-enhanced CT scan. Each abbreviation in the table is expressingas follows: EtoH, the amount of ethanol; L, longest diameter; S, shortest diameter; H, height; V, the volume of coagulated necrusis; T-ENE, total energy requirement: T-ENE/V, the energy requirement for inducing coagulation of per urit volume. The coagulated necrosis in PET-RFA group was enlarged in 3 dimensions compared with thegroup of RFA alone, although the total energy requirement was comparable between groupsTable 3 Comparative study of coagulated necrosis in the groups classified according to the amount of ethanol injected in PEI-RFAEtoH (mL)L(ams(am) H(om) V(cm) T-ENE () T-ENE/V /cm)EtoH <6.9 mL30±0636±09223±14348901±232192796±1752=4])(1)EtOH >6, mL149±6.51±13576±38263931±347441460±1016P<0.U00100002J.00<0.00010.1l0.0U14The mean volume afethanmL. Therefore, 60 patients treated with PEl-RFA were divided into two groups according to the ainjected. One group(high ENOH group)consisted of 19 cases administered with 6.9 mL and more ethanol, and the other (low EtOH group)of 41 cases less than 6. mLethanol. Each abbreviation in theexpressing as follows: EtOH, the amount of ethanol; L, longestdiameter; S, shortest diameter H, height: V, the volume of coagulatednecrosis; T-ENE, total energy requirement; T-ENE/V, the cnergy requirement for inducing coagulation of per unit volume. The volume of coagulated necrosis in the highEtOH group was 26 times larger than that in the low EtOH group, although the total energy requirement was comparable between groups.Table 4 Comparative study of coagulated necrosis In the groups classified according to the total energy requirement in PEI-RFAEtOH (mL)(cm)58±5836=0.836:1.024.6±1732003±127432038±1638TENE>5382848:1238±124壬±l.24C36,47884±195672727±1687000028<0.0UU10D52A cases treated with PEl-RPA were divided into two groups. One was high energy group and the other low energy group according to the mean amount ofquirement(53828 Joule). Each abbreviation in the table is expressing as follows: EtOH, the amount of ethanol; L, longest diameter; S, shortest diameter; H,height;V,theecrosis; T-ENE, total energy requirement; T-ENE/V, the energy requirement for inducing coagulation of per unit volume. The amount of ethanolparable in both groups. The volume of coagulated necrosis in the high energy group was 1. 8 times larger than that in the low energy groupThe degreendingeffect was smaller compared with that in cases classified by the mean amount of injected ethanol as shown in Table 3. Furthermore, the energyation of per unit volume was comparable between groups.for inducing coagulation of per unit volume in the groups treated with PEI-RFA were divided into two groupsof PEI-RFA and RFA alone are shown in Table 2. The according to the amount of ethanol injected. One grouplongest and shortest diameters as well as the height of the(high-EtOH group)consisted of 19 cases administered withcoagulated necrosis areas and the coagulated volume 6.9 mI and more ethanol and the other(low-ErOH gtoupevaluated by dynamic contrast-enhanced CT scan were of 41 cases less than 6.9 mL ethanol. Between these twothose treated with RFA alone. By contrast, the total amount as shown in Table 1. However, the volume o Comparablesignificantly larger in cases treated with PEI-RFA than in groups, the total energy requirement was alsoof energy requirement was compatable between groups. necrosis was significantly larger in the high-EtoH grouplation of per unit than in the low-EtOH group. The volume of coagulatedvolume was significantly smaller in PEI-RFA group compared necrosis in the high-ErOH group was 2.6 times larger thanto the group of RFa alone. The energy requirement for that in the low-EtOH group. Accordingly, the energycoagulation of per unit volume in PEI-RFA was approximatelree-fourths of that in rFa alone中国煤化工 volume in the highEtOHthanCNMHG gh-EtOH groupComparative study of the coagulated necrosis and the energyAll cases treated with PEl-RFA were divided intorequiement for coagulation of per unit volume between PEHRFA two groups. One was high-energy group and the otherand RFA groupslow-energy gtoup according to the mean amount of totalAs shown in Table 3, the mean volume of ethanol injected energy requirement(53 828 D. As shown in Table 4, in thisin P FAgToup was 6. 9 mL. Therefore, 60 patients classification, the amount of ethanol injected was statisticallyKurokohchi K et a Energy requirement in PEI-RFA for HCC treatmentcomparable in both groups. The volume of coagulated Relationshlp between the total required energy for ablationnecrosis in the high-energy group was 1.8 times larger than and the volume of coagulated necrosis orthe energy requirementthat in the low-energy group. The degree of the enhancing for coagulation of per unit volumeeffect was smaller compared to that in cases classified by Relationship between the total required energy and thethe mean amount of ethanol injected as shown in Table 2. volume of the coagulated necrosis or the energy requirementFurthermore, the energy requirement for coagulation of for coagulation of per unit volume was analyzed in theper unit volume was comparable between groupstotal subjects treated with PEI-RFA (60 cases). As shown inFigure 3, the total required energy significantly and positivelyRelationship between the amount of ethanol and the volume correlated with the volume of coagulated necrosis(=0.47,of coagulated necrosis or the energy requirement for P=0.0013). However, this correlation coefficient wascoagulation of per unit volumesmaller than that between the amount of ethanol injectedRelationship between the amount of ethanol injected and and the volume of coagulated necrosis. Moreover, the totalthe volume of coagulated necrosis or the energy requirement required energy and the energy requirement for coagulationfor coagulation of per unit volume was analyzed in the of pcr unit volume did not show significant correlationotal subjects treated with PEI-RFA (60 cases). As shown in (=0.35, P=0.13)Figure 2, the amount of ethanol injected into tumorgnificantly and positively correlated with the volume of Representative cases with HCC treated with PEARFAcoagulated necrosis with high corrclation coefficient(r=0.71, By analyzing the relationship between the energyP<00001). Then, the amount of ethanol injected negatively, requirement and the amount of ethanol injected in PEI-RFAalthough wcak, correlated with the energy requirement for two characteristic points have been turned out: (1)PEI-RFAcoagulation of per unit volumc(=-0.41, P=0.014). These enables to induce wider coagulated nectosis by increasingresults suggest that, according to the amount of ethanol the amount of ethanol injected into tumor;(2) PEI-RFA isnjcctcd into tumor, larger coagulated necrosis can be able to obtain comparative therapeutic effects by means ofbtained and less amount of cnergy is required for lower energy compared to RFA alonecoagulation of per unit volume.Four cases with HCC treated with PEl-RFA expressing150A150100088§88昌§Ethanol(mL)R导8888导B1000080008000。°6000400002030吕8Ethanol (mL)Total energy Joule)Figure凵中国煤化工Figure 2 Relhip between the amount of ethanol injected and ment ale volume of coagulated necrosis or the energy requirement for In- mentCNMHGated necrosis in PEI-RFAducing per unit volume of coagulated necrosis in PEl-RFA PEH-RFA PEHRFpauens win HCC. The ablation wastients with HCC. the abby done by using the Cool-tip RF system. The amount of total energyusing the Cool-tip RF system. the amount of ethanol injected into requirement positively correlated with the volume of coagulated ne-tumors positively correlated with the volume of coagulated necrosis cross(r-0. 47, P- 0.0013), whereas no slgnlflcant correlation wasbetween the total amount of energy redrequirement for inducing per unit volume of coagulated necrosis sis r o. s. epme ot 1 in PEl- Ar unit oume of coagulated necro.1430ISSN 1007-9327 CN 14-1219/R World J Gastroenterol March 14, 2005 Volume 11 Number 108 am5cmFigure 4 Two cases with large-sized HCC treated with PEI-RFA are shown Contrast-enhanced CT before(A: delay phase, chase)and after( B: delayD: delay phase)PEl-RFA Massive HCCs of 5 cm in the longest diameter werever in both cases. in thee(A and B, RFa was started at 30 w and the power output was increased stepwise to 100 wnd the ablation wasor 20 mn. In the second case(c and D), because the tumor was located close by blood vessel stvena cava, portal tract and aorta it was likely to be difficult to treat with RFA under high power control. After Injecting 19 mL of ethanol intothe tumor, one session of RFA was performedw for 12 min, The massive tumor was completely eliminated by PEI-RFA5×3,0cmD3.0cmFIgure 5 Twunder low power outpute shown Contrast-enhanced ct before(A,)and after(B, D)PEH-RFA Small HCCs ofdiameter were located in the s8 region of the liver in both cases. In both cases,FA was perperformed at relatively low power output for short duration, the coagulatednecrosis larger than 2.5 cm was induced中国煤化工CNMHGthese characteristic points are shown in Figures 4, 5. The of ethanol homogenously into the tumor. The RFAlarge-sizcd HCCs(5 cm in diameter) of the first and second electrode was reinserted into the tumor and the RFa wascases were located in S7(Figure 4A) and S1 regions performed for further 10 min. Contrast-cnhanced CT after(Figurc 4C) respectively. In the first case, RFA was the trcatment showed the achievement of coagulatedKurokohchi K et a/ Energy requirement in PEI-RFA for HCC treatment1431the entire region of the tumor including thc safety margin the coagulated volumc evaluated by dynamic contrastFigure 4B). In the sccond case, contrast-enhanced CT enhanced CT scan were significantly larger in cases treatedshowed the enhancement in the early vascular phase of with PEI-RFA than in those treated with RFa alone usingdynamic CT Figure 4C). It was likely to be difficult to treat the system equipped with an expandable type of clectrodewith RFA under high power output, because the tumor was (RITA-500PA)l. Similar enhancing effects of ethanolsurrounded by inferior vena cava, portal tract and aorta. injection were obscrved in the present study using the Cool-tipThercfore, PEI-RFA under a relatively low power output RF system. The volume of coagulated necrosis in PEI-RFAafter injecting high amount of ethanol was choscn as a was approximately four times larger than that in RFA alonetreatment modality. After injecting 19 mL of ethanol into in the Cool-tip RF system. This degrec of enhancement ofthe tumor, one session of RFA was performed at 30 W for coagulated necrosis area was quite similar to that detected12 min. Contrast-cnhanced CT after the treatmcnt showed in the system with the expandable type of electrode in ourthat the ablated region reached the most of the entire region previous manuscripts. These results suggest that injectionof the tumor in this case as well(Figurc 4D)of cthanol prior to RFA therapy may equally enhance theThe HCCs of the third and fourth cases are located in volumc of coagulated necrosis in 3 dimensions to the sameS8(Figure 5A)and S6(Figure 5C)respectively and the size extent regardless of types of RFA instruments.of both HCCs was 1.5 cm in diameter To obtain over 0.5 cIMore importantly and interestingly, it should be notedof the safety margin area from the cdgc of the tumor, the that the volume and diameters of coagulated necrosis wereoagulated necrosis wider than 2.5 cm in diameter was significantly larger in PEl-RFA than in RFA alone, althoughrequired for the ablation. In both cases, aftcr injecting 2 mL the amount of total cnergy requirement was comparableof ethanol into the tumors, RFA was performed at 40W betwcen groups. Thus, the cnergy requirement forfor 5 min. Although RFA was performed under a relatively coagulation of per unit volume was significantly lower inlow power output and for a short time period, dynamic PEI-RFA than in RFA alone. The degree of enhancementCT after PEI-RFA in both cascs indicated the induction of coagulated necrosis was higher between the groupsof coagulated necrosis larger than 2.5 cm in diameter classified according to the amount of injected ethanol than(Figure 5B, D). In the third case, the energy rcquirement between those classified according to the amount of totalfor coagulation of per unit volume was an extrcmely low energy requirement. The former was 2.6-times enhancementlevel of 1244(/cm), a half-value of the mcan in PEI-RFA and the latter was 1.8 times. Furthermore, the volume ofgroup as shown in the Table 2coagulated necrosis showed a stronger correlation with themount of ethanol injected than the total encrgy requirement(r=0.71 us 0. 47)respectively. While the amount of injectedDISCUSSIONcthanol, negatively correlated with the energy requirementRFA is a promising technique for local control of liver for coagulation of per unit volume, the total required enerymalignancy such as primary hepatocellular carcinoma. 2,241 did not show ncgative correlation with the energyand mctastatic liver cancers Rs. This technique has become requirement for coagulation of per unit volume. Takenhe main stream of the treatment of non-surgical treatment together, these results clearly indicate that smaller energy ismodalities in clinical settings p1. In contrast to its efficacy, required in PEI-RFA to induce comparable coagulatedthe region of coagulated necrosis induced by RFA is still necrosis to RFA alone, and the usc of ethanol injectionlimited and rumors within 3 cm in diameter are thought to prior to RFA is likely to alter the RFA therapy to a milderbe the good application sites of RFA therapy. Underestimated one for the treatment of patients with HCC. Thesc resultscomplication was sometimes observed after RFA treatment. may be one of the explanations that PEI-RFA is able toTo enhance the therapeutic effect of RFA, several treatment induce wider coagulated necrosis compared to RFA alonemodhave bccnadditional trcatments on under the same power output conditionlocal treatment. It has bcen reported that combincd use of Although it is possible to say that RFA is less invasivetranscatheter arterial chemocmbolization or saline injection compared to surgical treatment, we have experienced sometherapy with RFA enhanced the extent of induced patients whose liver function tests declined after RFAcoagulation(-4 1720. Recently, Pawlik ef al. have reported treatment. Furthermore, RFA treatment has somctimes beenthat resection combined with RFa provides a surgical option obliged to be ceased duc to the pain complained by patientsa group of patients with unresectable liver metastasesi2x, during the treatment. Thercfore, it is very important toAs one of the optional combination therapies, we have shown devclop less invasive treatments than those currently usedthat the injection of cthanol prior to RFA markedly incrcased It is needless to say that less invasive and more effectivethe induced coagulated necrosis in humana, and bovine treatment is desirable for local control of HCC in patientslivcrs. In the present study we further evaluated the treated with RFAscfulncss of PEI-RFA using the system equipped with a W中国煤化工mcr, it should becool-tip type electrode, instead of the system with an impexpandable type electrode. Especially, the characteristics of into coCNMHGRFA is thought to bePEI-RFA wcrc assessed from the standpoint of energy a less invasive and morc effective treatment modality forrequirement for inducing the coagulated necrosis and the local control of hepatic malignancies than RFA alone. PEIamount of ethanol injected. In our previous manuscript, RIA is expected to contribute to the local treatment of paticntswe have shown that the longest and the shortest diameters with hepatic malignancy from the standpoint of not only theas wllastbs height of the coagulated necrosis arcas, and effectiveness but also the reduction of adverse eventsISSN 1007-9327 CN 14-1219/R World J Gastroenterol March 14, 2005 Volume 11 Number 10REFERENCES16 Burdio F, Guemes A, Burdio M, Navarro A, Sousa R, CastiellaT, Cruz l, Burzaco O, Guirao X, Lozano R. 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