Percutaneous Treatment of Hydatid Liver Cyst - IngentaConnect

Recent Patents on Anti-Infective Drug Discovery, 2009, 4, 29-36

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Percutaneous Treatment of Hydatid Liver Cyst Antonio Giorgio, Antonella Di Sarno, Giorgio de Stefano, Nunzia Farella, Paolo Matteucci, Umberto Scognamiglio, Valentina Giorgio Infectious Disease and Interventional Ultrasound Unit, “D. Cotugno” Hospital, Naples, Italy Received: December 18, 2008; Accepted: December 30, 2008; Revised: January 5, 2008

Abstract: Percutaneous treatment of Hydatid Liver Cyst (HLC) with scolicidal agent under ultrasound guidance is now worldwide used after the advent of Percutaneous-Aspiration-Injection and Re-Aspiration (PAIR) and its modifications. Although HLC represent a benign disease, treatment has to be considered mandatory in symptomatic cysts and recommended in viable cysts because of the risk of severe complications. In this article, clinical indications, PAIR technique with results and complications are discussed. Finally, clinical flow-chart of active and inactive HLCs is reported. The present article is a review of some patents in the Hydatid liver cyst.

Keywords: Liver, interventional ultrasound, hydatid liver cyst, percutaneous-aspiration-injection and re-aspiration (PAIR), double-percutaneous-aspiration-and ethanol injection (D-PAI). INTRODUCTION Cystic echinococcosis (CE) is a parasitic disease due to the larval form of a tapeworm, Echinococcus granulosus. Cystic hydatid disease mainly affects the liver (50-70% of all cysts) but can also develop in lung (20-30%) and, less frequently, in spleen, kidney, bone, brain, and other organs [1]. The disease is endemic in the Mediterranean area, in the Middle East, the Baltic areas, South America, India, Northern China and other sheep-raising areas; however, considering the increased travels and tourism all over the world, it can be found anywhere, even in developing countries [2-5]. Liver hydatidosis develop when the parasite’s eggs are ingested and the embryonic forms are released into the intestinal lumen and cross the mucosa, reaching the hepatic sinusoids via the portal circulation [6]. The hydatid liver cyst (HLC) represents the full-blown expression of the vital parasite, whereas a number of other morphologic features that are finely depicted by Ultrasonography (US) represent various stages in the parasite’s life cycle [7-9]. On US HLCs can appear as a) unilocular pure liquid cyst with well-defined or undefined wall, b) with detached membranes or c) as multivesicular cyst with multiple daughter cysts or with d) solid or e) calcified lesion. The last WHO 2003 classification [10] considers all US features that contain liquid (univesicular [CL, CE1 types], with multivesicular appearance [CE2 type], with detached membranes [CE3 type], as signs of living worms, whereas solid and calcified appearance should be indicative of inactive forms Fig. (1). According to this classification, only patients with viable cysts are suitable for therapy. HLC is usually asymptomatic; however, a number of complications can cause morbidity and occasional mortality. HLC can cause dissemination and/or anaphylaxis after cyst’s rupture into peritoneum or into the biliary tract. Infection of the cyst can facilitate the development of liver abscesses and mechanical local complications, such as mass *Address correspondence to this author at the Infectious Disease and Interventional Ultrasound Unit, “D. Cotugno” Hospital, via G. Quagliariello n. 54 Naples, Italy; Tel: +390815908278; E-mail: [email protected] 1574-891X/09 $100.00+.00

effect on bile ducts and vessels that can respectively induce cholestasis, portal hypertension and Budd-Chiari syndrome [1, 11]. Therefore, even if HLC can be considered a benign disease, treatment has to be considered mandatory in symptomatic cysts and recommended in active cysts, because of the risk of severe complications [12]. Zhang et al. discuss the use of novel proteins of Echinococcus to identify the cause for hydatid disease [13]. The treatment of HLC is based on medical therapy with albendazole or praziquantel, on surgery and percutaneous approach. Albendazole has shown low efficacy when used alone (see below) and a large number of side effects, in particular on liver function with elevation of liver enzymes up to fulminant hepatitis [11]. Open surgery (partial, such as cystectomy or radical, peri-cystectomy) has been considered the standard of cure up to last years; laparoscopic approach should be a valid surgical alternative choice by expert surgeons [14, 15]. Surgery is expensive and not available worldwide. Therefore, during the last decades minimally invasive techniques have been introduced in the treatment of HLC: 95% sterile ethanol and or hypertonic saline can be injected within the cyst percutaneously after fluid aspiration, with excellent results in terms of disappearance of the cysts, very few side-effects and low mortality rate [16-18]. The main concern of percutaneous treatment modalities is the possibility of spillage of the Echinococci during the percutaneous aspiration of the cysts and injection of the scolicidal agents, which can lead to peritoneal dissemination and anaphylactic reactions. However, in the Literature there are very few reports of these complications when the percutaneous approach is performed by an experienced operator [16, 19, 20]. PERCUTANEOUS- ASPIRATION- INJECTION AND RE-ASPIRATION (PAIR) AND ITS MODIFIED TECHNIQUES The percutaneous treatment of viable HLCs is based on Percutaneous-Aspiration-Injection and Re-Aspiration (PAIR) Fig. (2). This technique includes the US-guided percutaneous © 2009 Bentham Science Publishers Ltd.

30 Recent Patents on Anti-Infective Drug Discovery, 2009, Vol. 4, No. 1

Giorgio et al.

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1c

1d

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1g Fig. (1). (a/g) : WHO-2003 classification of HLCs a: CL type: small HLC with no well defined wall b: CE1 type: large univesicular HLC with well defined wall c: CE 2 type: medium-sized multivesicular HCL with numerous daughter cysts d: CE3 type: large HCL with detached inner membrane, floating in the cyst e: CE3 type: HCL with mixed pattern: solid and liquid daughter cysts f: CE4 type: HCL with solid pseudo-tumor appearance g: CE5 type: small HCL with calcified wall Usually CE 4 and CE5 types are inactive cysts

Percutaneous Treatment of HLC

Recent Patents on Anti-Infective Drug Discovery, 2009, Vol. 4, No. 1

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2c Fig. (2). (a/d) : Sonographic findings showing PAIR technique and follow-up appearance

2d

a: large univesicular HCL during puncture: the needle tip is clearly visible. Arrows = needle tip b: soon after the needle puncture, detachment of inner membrane is observed c: the ethanol injected appears as a white cloud d: three months after puncture and ethanol injection, the HLC shows decreased volume and solid pattern. This pattern will show no change during nine years follow-up

puncture of the cystic fluid, the aspiration of the maximum amount of fluid, the injection of a scolicidal agent (20-30% hypertonic saline or 95% sterile ethanol) and the reaspiration of the scolicidal agent after 30 minutes. The first author who performed PAIR was Mueller [21] who drained an HLC using silver nitrate as scolicidal agent in a 80 years old woman not eligible for surgery [21]. No complications occurred and shrinkage of the cyst was observed. The Tunisian Group of Ben Amor [17] and co-workers introduced the PAIR technique firstly in the sheep and then in humans. These authors used 30% hypertonic saline as scolicidal agent and the percutaneous drainage was performed either with fine needle or sump catheter. Table 1 shows, in order of time, the authors, the scolicidal agents and the methods employed (needle or catheter drainage). The 95% sterile ethanol was firstly employed by Filice et al. [22], following the experience of percutaneous ethanol injection in the treatment of hepatocellular carcinoma (HCC), introduced by Livraghi [23]. Khuroo et al. [24] used 20% hypertonic saline and, lastly, Patsoy et al. employed albendazole solution as direct scolicidal agent [25]. In 1992 [19] we

introduced a modified technique of PAIR, termed DoublePercutaneous-Aspiration and ethanol Injection (D-PAI) which includes the percutaneous needle puncture and aspiration of the cystic fluid, the injection of 95% sterile ethanol (50-60% respect to the aspirated fluid) and the ethanol is not re-aspirated but left in situ. The same procedure is then repeated 3/7 days later. PERCUTANEOUS TECHNIQUES RESULTS “The good results obtained in a group of 16 animals” permitted to Ben Amor and co-workers to apply PAIR in two patients not eligible for surgery; the results were excellent in a case of peritoneal cyst while the liver cyst treated showed sign of involution [17]. Gargoury et al. continued to report good results in 37 patients with 120 cysts punctured without major complications [26]. The first prospective, controlled, randomized trial comparing percutaneous drainage versus albendazole therapy in HLC was conducted by Khuroo et al. in 1993 [11]; thirty-three patients with 33 HLCs were randomized to receive percutaneous drainage (PD) (11 patients), PD plus albendazole (11 patients) and albendazole


Table 1.

Giorgio et al.

List of Authors, Scolicidal Agents and Methods Used for the Percutaneous Puncture and Treatment of HLCs Author

Year

Scolicidal agent

Methods

Mueller

1985

Silver nitrate

Catheter

Ben Amor

1986

30% Hypertonic saline

Needle-catheter

Filice

1990

95% Ethanol

Catheter

Khuroo

1991

20% Saline hypertonic

Needle-catheter

Giorgio

1992

95% Ethanol

Needle

Paksoy

2005

Albendazole solution

Needle

alone (11 patients) [11]. All twenty-two cysts treated with PD and only 2 cysts treated with albendazole alone showed reduced size and change in echo-pattern (p < 0.01). The maximum size reduction was observed in cysts treated with PD and albendazole (p < 0.05), but albendazole alone had 35% of side effects, in particular elevation of liver cell enzymes which was reversible (11). In 1997 Khuroo [16] compared PD and surgical cystectomy in the treatment of HLCs. Fifty HLC patients were randomized to receive PD plus albendazole (25 patients) or cystectomy (25 patients). The mean hospital stay was 4.2 + 1.5 in PD group and 12.1 + 6.5 in surgical group. The mean cyst diameter decreased from 8.0 + 30 to 1.4 + 3.5 cm in PD group and from 9.1 + 30 to 0.9 + 1.8 cm in surgical group (p = 0.20). The cysts disappeared in 88% in PD group and in 72% of surgical group. Complications were observed in 32% of PD group and in 84% of surgical group. The authors concluded that PD plus albendazole was an effective and safe alternative to surgery for the treatment of uncomplicated HLCs and require shorter hospital stay [16]. Recently albendazole was used as unique scolicidal agent in the percutaneous treatment of HLCs [25, 27]. Two independent investigators presented the experimental and clinical results in rabbits and humans, respectively [25, 27]. Yetim et al. [27] studied the effects of intra-cystic injection of alcohol and albendazole on HLCs of three groups of rabbits: a control group, an alcohol group and an albendazole group. In all three groups hepatic hydatidosis was induced. In their experimental study, these authors found that alcohol and albendazole solutions are both effective [26]. Higher scolicidal effects and lesser side effects on hepatobiliary system were the advantages of albendazole solution. In the same year Paksoy et al. compared the direct injection of albendazole solution and hypertonic saline in HLCs in humans [25]. Fifty-nine patients with 109 HLCs were assigned in two groups: the group 1 (31 patients with 40 cysts) were treated with PAIR using the hypertonic saline as scolicidal agent and 28 patients with 69 cysts (group 2) were treated with PAIR using the albendazole solution. The authors found that hypertonic saline and albendazole solution were both able to inactivate the scolices and no differences between the two groups in cyst size reducing were observed; they concluded that in addition to its oral use, albendazole may be injected into the cyst inducing the sterilization of the cystic cavity [25]. Myhr in WO patent disclosed the use of

ultrasound treatment in order to focused at the region of interest [28]. PAIR AND D-PAI LONG TERM RESULTS From the beginning of PAIR introduction more and more patients have been treated worldwide and, therefore, longterm results are now available. In the series of Akhan et al. [20] thirty-one patients with 57 HLCs underwent PAIR with hypertonic saline and/or 95% sterile alcohol. Volume reduction ranged from 18 to 99% (mean 83%), disappearance of the fluid component and pseudo-tumor appearance were observed on US and no mortality occurred. Major complications were infection of the cavity, hypersensitivity reaction and development of a biliary fistula. One cyst recurred 11 months after PAIR. Ustunsoz et al. [29] treated with PAIR one hundred and six cysts followed- up to 37 months. Sixty-six cysts were smaller than 6 cm and underwent needle aspiration while forty cysts were larger and underwent catheter drainage. Seventy out of 72 cysts were cured and 2 recurrences (2.8%) were observed. Mortality was 0%. Major complications were infection of cystic cavity and a biliary fistula. In the series of Odev et al. sixty-one patients with 84 treated cysts were followed up to 72 months [30]. During the follow-up after PAIR, US revealed a heterogeneous echo pattern in seventy-eight cysts (93%), a progressive decrease of diameter in 76 cysts (90%), calcification of the cyst’s wall and cystic content or both in the 10 cysts (12%) and the complete disappearance of the one cyst (1%). Bosanac et al. treated fifty-two patients with 55 HLCs and followed-up them for 6-9 years. All the patients were successfully treated; regarding complications, only 3 patients developed a secondary infection, due to prolonged catheter drainage [31]. Etlik et al. during a follow-up of 17-53 months of thirtythree patients with 52 treated cysts, observed a decrease in size of cysts, solidifications of the contents and irregularity of the cystic wall in all patients. Anaphylaxis was encountered in one case and a local recurrence in 1 patient [32]. The PAIR technique has been applied even in children, Goktay et al. treated thirty-four patients (mean age 9.4 years)



with 51 HLCs; the follow-up ranged from 1 to 6 years and results were good [33].

Smego et al. in a meta-analysis on seven hundred and sixty nine HLCs patients treated with PAIR plus albendazole and 952 matched controls treated with surgery, found that PAIR plus chemotherapy is associated with greater clinical and parasitological efficacy, lower rates of morbidity, mortality, disease recurrence and shorter hospital stay [40].

In our long-lasting experience with D-PAI one hundred and sixty-eight treated patients were followed- up to 17 years. The disappearance of the cysts was observed in 48.4% of cases; 46.2% of cases showed a solid US pattern and the remaining 5.3% of cases showed a residual small minimal fluid component with no viable scolices on needle aspiration [34]. These data indicate a parasitological cure in 100% of case. We had one case of fatal anaphylactic shock in a patient with post surgical recurrence. A similar case of anaphylactic shock is reported in the series of Men et al. [35]. Other major complications encountered during our long-term experience were infection of the cyst in two cases, a biliary fistula in 1 case and a cystic haemorrhage in 1 case [34]. In our experience with D-PAI, local recurrences were observed in 4% of patients and all occurred in multivesicular cysts [34]. This is an expected finding because in multivesicular cysts the ethanol injected, even if left in situ, cannot reach all points of the inner membrane, so to inactivate all viable scolices. Zerem et al. reported retrospectively, the effects of PAIR on univesicular HLC compared to results of treatment of multivesicular HLCs [36]. The mean diameter of the cysts decreased from 83.3 + 38.6 cm to 11.1 + 16.0 cm in the multivesicular group and the final cyst’s diameter did not differ significantly between the two groups. The disappearance of the cysts was higher in univesicular group compared with multivesicular group but no difference was observed for the hospital stay in the two groups [36]. CAN BE PAIR CONSIDERED AS FIRST LINE THERAPY FOR HLCs? This is a very interesting still open question. In the 2006 Cochrane Data Base systematic Review [37] to assess the benefits and harms of PAIR with or without albendazole for patient with uncomplicated HLCs in comparison with no intervention, surgery or medical treatment, only two randomized clinical trials, one comparing PAIR versus albendazole alone [11], and the other one comparing PAIR versus surgical treatment [16], were found. The conclusions of the authors were that PAIR seem promising, but there is insufficient evidence to support or refute PAIR for treating patients with uncomplicated HLCs. But other recent data of the Literature should be considered. In 2006, Kabaaliolu et al. [38], according to their experience, concluded that PAIR of CL and CE1 HLC types is safe and effective in the long-term and surgery should no longer be regarded as the first choice treatment in all HLCs but should be reserved for CE4 and CE5 cysts. The results of a recent review by Dziri et al. [39] to provide evidence-based answers to the questions “Should chemotherapy be used alone or in association with surgery? What is the best surgical technique? When PAIR is indicated ? ” showed that chemotherapy is not the ideal treatment for uncomplicated HLCs when used alone and the level of evidence was too low to help choosing between radical or conservative treatment [39]. Percutaneous drainage plus albendazole resulted safe and efficient in selected patients [39].

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In our recent non-randomized prospective study on DPAI as first line therapy this technique showed high efficacy, very few side effects (3.5%) and low mortality rate (0.7%), in patients with viable HLCs previously untreated [41]. Moreover, the disappearance of the cysts with sonographic reconstitution of liver parenchyma was observed in a high percentage of the cysts (65.2%). These results, although not reported in other series with long-term follow-up [18, 20, 29, 31-33], are similar to our previous 11 year experience [42] on 106 viable HLCs respect to 210 of last series. As far as surgery is concerned, in surgical series with long-term follow-up, mortality ranges from 0.3 to 7% [43, 44], operative time is up to 175 minutes and hospital stay ranges from 6 (in laparoscopic series) to 15 days in open radical surgery [43, 44]. In recent years, in a large series [45] of five hundred and ten HLCs in 355 patients, PAIR recurrence rate was 3.5% compared to recurrences rates of 16.2% and 3.3% for open and laparoscopic surgery, respectively. In surgical series the reported complications range from 6% to 47 % [46-49]. Therefore, considering the high parasitological cure rate, the low complications rate, the low cost, the simplicity of this technique and the short hospital stay using PAIR or D-PAI, the percutaneous approaches should be considered the first choice therapy for HLCs. Figure 3 shows our flow chart in the sonographic and clinical management of HLC. Preito et al. discussed in US patent 20061088477 the use of interferon in viral hepatopathies [50]. NEW PERSPECTIVES RADIOFREQUENCY ABLATION OF HLC Recently, Du et al. on the basis of the worldwide experience with radiofrequency ablation( RF) of Hepatocellular carcinoma on cirrhosis, reported the results of RF ablation on sixty-three simple, non parasitic, liver cysts in 29 patients (51). Small cysts (< 5 cm) were all ablated and large cysts became solid and showed decreased volume (6070%) on US. Therefore they proposed to treat hepatic biliary cysts with RF because of its efficacy and absence of complications. Bastid et al. reported the first case of HLC treated with RF plus ethanol so to increase the scolicidal and sclerotic effects on inner membrane [52]. Six months after RF plus ethanol injection the patient was in very good condition, liver and blood tests were normal and cystic cavity was reduced on US. On the basis of these experiences, we treated five patients with 5 viable HLCs, previously treated with PAIR and still viable scolices on percutaneous needle aspiration [53]. All five cysts exhibited mixed (liquidsolid) pattern on US before RF ablation. The RF procedure consists in the percutaneous catheter aspiration of the liquid portion of HLC and soon after in the introduction of an electrode expandable needle and delivery of RF energy up to


Giorgio et al.

Fig. (3). Flow chart of sonographic and clinical management of HLC using D-PAI.

15 minutes. After procedure (the follow-up ranges from 3 to 6 months) a parasitological cure was achieved in 100% of cases. All cysts showed no viable scolices after following needle aspiration and 4 out of 5 cysts showed 60% decreased volume on US. No major or minor complications were observed. These preliminary results seem promising in the treatment of viable HLCs with percutaneous RF ablation alone, without ethanol injection, and show that RF ablation of HLCs can be effective and safe in cases in which PAIR fails.

Arthur et al. in US patent shows the new method for the resolution of liver fibrosis by the induction of hepatic stellate cell (HSC) apoptosis in vivo [54]. CURRENT & FUTURE DEVELOPMENTS PAIR and its modified techniques are effective and safe in the treatment of viable univesicular and multivesicular HLCs not only in the short-term, but also in the long- term, and now should be considered as first line therapy in



univesicular viable HLCs. The technique has a low cost, the hospital stay is very short and the complications are rare; moreover the few cases of local recurrences can be retreated percutaneously. Therefore, PAIR or D-PAI can be adopted not only in developing but also in Western countries; obviously these procedures should be performed by an expert operator with many years experience in interventional ultrasound.

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