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Why abandon the idea of a microinvasive approach in case of lesions in high risk positions?

Liver

PBLite is Elesta Thermotherapy using the ECHOLASER systems to treat primary and secondary malignant liver cancers.

The name of the treatment contains in a single word the application area (the liver, “PB” is the abbreviation of Prometheus bound, the titan who in Greek mythology was condemned to be bound to the rocks of the Caucasus while an eagle pecked at his liver each day) and “Lite”, which on one hand refers to the lightweight and micro-invasiveness of the treatment, and on the other, the therapeutic source (Light, therefore Laser).

The name PBLite allows for differentiating the procedure with ECHOLASER (micro-invasiveness and multi-fibre approach in a single system) from the other thermal ablation techniques.

Indications

PBLite is indicated in the treatment of primitive and secondary liver cancer in the form of focal lesions. PBLite is also a safe and effective treatment of those who, due to critical medical conditions, are not able to undergo surgery.

What is it?

PBLite consists of the percutaneous insertion of optical fibres (from 1 to 4 depending on the size of the tumour), and the delivery of laser energy for several minutes which causes the heating of the tissues until they are completely destroyed with a sufficient safety margin. The positioning of the applicators, monitoring of the treatment and verification of the effective coagulation area are all carried out under ultrasound guidance. In order to facilitate the insertion manoeuvre, the system has dedicated multi-applicator Guiding Systems for ultrasound probes designed for the anatomical area of the liver with relative Biopsy Software that displays the guidelines on the screen. As these are malignant tumours, the objective of the treatment is complete ablation of the lesion and subsequent absence of post-treatment local relapses and a net increase in the long-term survival probabilities (5 years).

With just one PBLite session it is possible to treat liver lesions with a very wide size range and diameters of up to 5 cm thanks to the versatility offered by the multi-fibre approach. The localized thermal effect of PBLite makes it the gold standard for liver lesions close to structures at risk.

Clockwise:
1./2. SI2C41 Esaote probe with dedicated multi-fibre Guiding System
3./4. CA541 Esaote probe with dedicated multi-fibre Guiding System

Advantages

  • complete ablation with a sufficient safety margin
  • “in situ” thermal destruction
  • preservation of the healthy tissue and the organ function
  • highly predictable and repeatable coagulation volume as required for the safety margin
  • localized thermal effect in the target volume only, which makes the treatment possible close to sites at risk
  • use of fine, a-traumatic needles for liver organ
  • possibility of treating patients with pace-makers (excellent electromagnetic compatibility)
  • absence of general anesthesia
  • short duration of the treatment (few minutes)
  • rapid recovery times
  • no or insignificant post-treatment pain
  • brief hospitalization
  • bridging therapy for organ transplants

Clinical Cases

Clinical Case no.1:

Primary liver tumour close to vascular structures

A patient with partially exophytic liver cancer (white arrow in the Figure), located between a branch of the portal vein and the vena cava, underwent Laser Thermotherapy using four fibres, two positioned in the upper section of the portal vein and two in the lower section. The lesion which was particularly difficult to treat due to the surrounding veins, was completely ablated without any alterations to the surrounding vascular structures.

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US image before the treatment

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MR image at one-month follow-up showing complete ablation (white arrow)

Images by courtesy of Dr. Giovan Giuseppe Di Costanzo (Cardarelli Hospital, Naples)

Clinical Case no.2:

Secondary colorectal cancer close to the heart

A patient with an 8-mm metastasis of the liver in segment I extremely close to the pericardium, was subjected to Laser Thermotherapy. The lesion was completely ablated without any complications involving the critical neighbouring structures such as pericardial effusion.

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US image before the treatment

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CEUS image after the treatment showing complete ablation

Images by courtesy of Dr. Sergio Sartori (Sant’Anna Hospital, Ferrara)

Publications

Efficacy and safety of percutaneous laser ablation therapy for treatment of large HCC.
Camera S, Di Costanzo GG, Tortora R, Addario L, Lampasi F, Tartaglione MT, Cossiga V, Donnaruma L, Caporaso N, Morisco F. 
Digestive and Liver Disease. 2016; 48 (1): e50.

Laser ablation with or without chemoembolization for unresectable neuroendocrine liver metastases: a pilot study
Pacella CM, Nasoni S, Grimaldi F, Di Stasio E,Misischi I, Bianchetti S, Papini E. 
International Journal of Endocrine Oncology May 2016, Vol.3, No.2, Pages 97-107

Laser ablation for small hepatocellular carcinoma: State of the art and future perspectives.
Di Costanzo GG, Francica G, Pacella CM.
World J Hepatol 2014 October 27; 6(10): 704-715

Radiofrequency Ablation versus Laser Ablation for the Treatment of Small Hepatocellular
Carcinoma in Cirrhosis: a Randomized Trial.

Di Costanzo GG, Tortora R, D Adamo G, De Luca M, Lampasi F, Addario L, Galeota Lanza A, Picciotto FP, Tartaglione MT, Cordone G, Imparato M, Mattera S, Pacella CM.
J Gastroenterol Hepatol. 2015 Mar;30(3): 559-65

A novel needle guide system to perform percutaneous laser ablation of liver tumors using the multifiber technique.
Di Costanzo GG, D’Adamo G, Tortora R, Zanfardino F, Mattera S, Francica G, Pacella CM.
Acta Radiol. 2013 May 23.

Effectiveness, Safety, and Local Progression After Percutaneous Laser Ablation for Hepatocellular Carcinoma Nodules up to 4 cm Are Not Affected by Tumor Location 
Francica G, Petrolati A, Di Stasio E, Pacella S, Stasi R, Pacella CM.
Vascular and Interventional Radiology 2012 February;199:1393–1401

Influence of ablative margin on local tumor progression and survival in patients with HCC ≤4 cm after laser ablation.
Francica G, Petrolati A, Di Stasio E, Pacella S, Stasi R, Pacella CM.
Acta Radiol. 2012 May 1;53(4):394-400.

Percutaneous laser ablation of hepatocellular carcinoma in patients with liver cirrhosis awaiting liver transplantation 
Pompili M, Pacella CM, Francica G, Angelico M, Tisone G, Craboledda P, Nicolardi E, Rapaccini GL, Gasbarrini G.
Eur J Radiol. 2009
Review Article: Laser Ablation for Small Hepatocellular Carcinoma
Pacella CM, Francica G, and Di Costanzo GG.
Radiology Research and Practise. 2011 Oct 20

Long-term outcome of cirrhotic patients with early hepatocellular carcinoma treated with ultrasound-guided percutaneous laser ablation: a retrospective analysis
Pacella CM, Francica G, Di Lascio FM, Arienti V, Antico E, Caspani B, Magnolfi F, Megna AS, Pretolani S, Regine R, Sponza M, Stasi R.
J Clin Oncol. 2009 Jun 1;27(16):2615-21

Percutaneous laser ablation of unresectable primary and metastatic adrenocortical carcinoma
Pacella CM, Stasi R, Bizzarri G, Pacella S, Graziano FM, Guglielmi R, Papini E.
Eur J Radiol. 2008 Apr; 66 (1):88-94

Complications of Laser Ablation for Hepatocellular Carcinoma: A Multicenter Study
Arienti V, Pretolani S, Pacella CM, Magnolfi F, Caspani B, Francica G, Megna AS, Regine R, Sponza M, Antico E, Di Lascio FM.
Radiology. 2008 Mar;246(3):947-55. Epub 2008 Jan 14.

Percutaneous laser ablation in patients with isolated unresectable liver metastases from colorectal cancer: Results of a phase II study.
Pacella CM, Valle D, Bizzarri G, Pacella S, Brunetti M, Maritati R, Osborn J, Stasi R. 
Acta Oncologica 2006; 45: 77-83

Analysis of factors predicting survival in patients with hepatocellular carcinoma treated with percutaneous laser ablation.
Pacella CM, Bizzarri G, Francica G, Forlini G, Petrolati A, Valle D, Anelli V, Bianchini A, Nuntis SD, Pacella S, Rossi Z, Osborn J, Stasi R. 
J Hepatol. 2006 Maggio;44(5):902-9

Percutaneous Laser Ablation in the Treatment of Hepatocellular Carcinoma with a Tumor Size of 4 cm or Smaller: Analysis of Factors Affecting the Achievement of Tumor Necrosis
Walser EM
J Vasc Interv Radiol 2005; 16:1427–1429

Laser Thermal Ablation in the Treatment of Small Hepatocellular Carcinoma: Results in 74 Patients
Pacella CM, Bizzarri G, Magnolfi F, Cecconi P, Caspani B, Anelli V, Bianchini A, Valle D, Pacella S, Manenti G, Rossi Z. 
Radiology. 2001 Dec; 221(3):712-20.

Hepatocellular Carcinoma: Long-term Results of Combined Treatment with Laser Thermal Ablation and Transcatheter Arterial Chemoembolization
Pacella CM, Bizzarri G, Cecconi P, Caspani B, Magnolfi F, Bianchini A, Anelli V, Pacella S, Rossi Z.
Radiology. 2001 Jun;219(3):669-78

Ultrasound-guided percutaneous laser ablation of liver tissue in a rabbit model
Pacella CM, Rossi Z, Bizzarri G, Papini E, Marinozzi V, Paliotta D, Castaldo R, Ziparo V, Garosi F, Cinti M, Muzzi F
European Radiology 1993; 3(1)

Clinical Trials

Radiofrequency Versus Laser Ablation for Hepatocellular Carcinoma

Randomised Clinical Trial
No. of patients enrolled: 140
Reference Study Centre: Cardarelli Hospital, Naples
Study Status: Completed
Registered on ClinicalTrial.gov: https://clinicaltrials.gov/ct2/show/NCT01096914?term=laser+radiofrequency+liver&rank=1
Publication of the results: Radiofrequency ablation versus laser ablation for the treatment of small hepatocellular carcinoma in cirrhosis: A randomized trial, Di Costanzo GG1, Tortora R, D’Adamo G, De Luca M, Lampasi F, Addario L, Galeota Lanza A, Picciotto FP, Tartaglione MT, Cordone G, Imparato M, Mattera S, Pacella CM. J Gastroenterol Hepatol. 2015 Mar;30(3):559-65.

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