Sutureless hepatic transection using a new radiofrequency assisted device. Theoretical model, experimental study and clinic trial

Article information

Abstract

The ideal instrument for performing hepatic transection should combine safe and rapid haemostasis in a single tool. We present a new multidisciplinary investigation designed to develop a hepatic transection device assisted by radiofrequency (RF);the investigation included: a computerised theoretical model, and experimental study and a clinical trial of this device. The theoretic modelling was performed by computer, based on the Finite Elements Method (FEM), with the objective of studying the distribution of electrical energy and temperature in the tissue, and to assess the effect of the characteristics of the instrument. The experimental study, based on an in vivo porcine model, suggested that the new instrument would allow the transection velocity of the hepatic parenchyma to be increased with lower bleeding per transection area compared with other techniques extensively used in liver surgery. These data should enable the first phase of clinical trial to be conducted, with preliminary results that suggest that the new device is safe and effective.

Keywords:

Hepatic transection instruments

Radiofrequency

Computer modelling

Experimental study and clinical trial

Resumen

El instrumento ideal para realizar la transección hepática debería aunar en una sola herramienta hemostasia segura y rápida. Presentamos nuestra investigación multidisciplinar encaminada al desarrollo de un dispositivo de transección hepática asistido por radiofrecuencia (RF); la investigación incluye: modelado teórico por computador, estudio experimental y ensayo clínico de este dispositivo. El modelado teórico se realizó por computador basado en el Método de Elementos Finitos (MEF) con objeto de estudiar la distribución de energía eléctrica y temperatura en el tejido y valorar el efecto de las características del instrumento. El estudio experimental basado en un modelo in vivo porcino sugiere que el nuevo instrumento permitiría aumentar la velocidad de transección del parénquima hepático con una menor hemorragia por área de transección al compararlo con otras técnicas ampliamente extendidas en la cirugía hepática. Estos datos permitieron afrontar la realización de la primera fase de un ensayo clínico, cuyos resultados preliminares sugieren que el nuevo instrumento es seguro y eficaz. los derechos reservados.

Palabras clave:

Instrumentos de transección

hepática

Radiofrecuencia

Modelado por computador

Estudio experimental y ensayo clínico

Full text is only aviable in PDF

References

[1.]

M. Palavecino, Y. Kishi, Y.S. Chun, D.L. Brown, V.N. Gottumukkala, B. Lichtiger, et al.

Two-surgeon technique of parenchymal transection contributes to reduced transfusion rate in patients undergoing major hepatectomy: analysis of 1,557 consecutive liver resections.

Surgery, 147 (2010), pp. 40-48

http://dx.doi.org/10.1016/j.surg.2009.06.027 | Medline

[2.]

E. Dixon, I. Datta, F.R. Sutherland, J.N. Vauthey.

Blood loss in surgical oncology: neglected quality indicator?.

J Surg Oncol, 99 (2009), pp. 508-512

http://dx.doi.org/10.1002/jso.21187 | Medline

[3.]

D.A. Geller, A. Tsung, V. Maheshwari, L.A. Rutstein, J.J. Fung, J. Wallis Marsh.

Hepatic resection in 170 patients using salinecooled radiofrequency coagulation.

HPB (Oxford), 7 (2005), pp. 208-213

[4.]

I. Di Carlo, E. Pulvirenti, A. Toro.

Use of dissecting sealer may affect the early outcome in patients submitted to hepatic resection.

HPB (Oxford), 10 (2008), pp. 271-274

[5.]

A. Chiappa, E. Bertani, R. Biffi, A.P. Zbar, G. Viale, G. Pruneri, et al.

Effectiveness of LigaSure diathermy coagulation in liver surgery.

Surg Technol Int, 17 (2008), pp. 33-38

Medline

[6.]

A. Ayav, L.R. Jiao, N.A. Habib.

Bloodless liver resection using radiofrequency energy.

Dig Surg, 24 (2007), pp. 314-317

http://dx.doi.org/10.1159/000103664 | Medline

[7.]

S.G. Delis, A. Bakoyiannis, N. Tassopoulos, K. Athanasiou, J. Madariaga, C. Dervenis.

Radiofrequency-assisted liver resection.

Surg Oncol, 17 (2008), pp. 81-86

http://dx.doi.org/10.1016/j.suronc.2007.10.046 | Medline

[8.]

S.C. Katz, J. Shia, K.H. Liau, M. Gonen, L. Ruo, W.R. Jarnagin, et al.

Operative blood loss independently predicts recurrence and survival after resection of hepatocellular carcinoma.

Ann Surg, 249 (2009), pp. 617-623

http://dx.doi.org/10.1097/SLA.0b013e31819ed22f | Medline

[9.]

R.T. Poon.

Current role of laparoscopic surgery for liver malignancies.

Surg Technol Int, 16 (2007), pp. 73-81

Medline

[10.]

K.S. Gurusamy, V. Pamecha, D. Sharma, B.R. Davidson.

Techniques for liver parenchymal transection in liver resection.

Cochrane Database Syst Rev, (2009),

[11.]

J. Santoyo, M.A. Suárez, J.L. Fernández Aguilar, J.A. Pérez-Daga, B. Sánchez-Pérez, A. González-Sánchez, et al.

[Solid organ transection. Open and laparoscopic surgery].

Cir Esp, 85 (2009), pp. 40-44

http://dx.doi.org/10.1016/S0009-739X(09)71627-6 | Medline

[12.]

P. Schemmer, H. Friess, C. Dervenis, J. Schmidt, J. Weitz, W. Uhl, et al.

The use of endo-GIA vascular staplers in liver surgery and their potential benefit: a review.

Dig Surg, 24 (2007), pp. 300-305

http://dx.doi.org/10.1159/000103662 | Medline

[13.]

P. Schemmer, H. Friess, U. Hinz, A. Mehrabi, T.W. Kraus, K. Z’Graggen, et al.

Stapler hepatectomy is a safe disresection technique: analysis of 300 patients.

World J Surg, 30 (2006), pp. 419-430

http://dx.doi.org/10.1007/s00268-005-0192-9 | Medline

[14.]

A. Saiura, J. Yamamoto, R. Koga, Y. Sakamoto, N. Kokudo, M. Seki, et al.

Usefulness of LigaSure for liver resection: analysis by randomized clinical trial.

Am J Surg, 192 (2006), pp. 41-45

http://dx.doi.org/10.1016/j.amjsurg.2006.01.025 | Medline

[15.]

A. Ayav, L. Jiao, R. Dickinson, J. Nicholls, M. Milicevic, R. Pellicci, et al.

Liver resection with a new multiprobe bipolar radiofrequency device.

Arch Surg, 143 (2008), pp. 396-401

http://dx.doi.org/10.1001/archsurg.143.4.396 | Medline

[16.]

S.M. Strasberg, J.A. Drebin, D. Linehan.

Use of a bipolar vesselsealing device for parenchymal transection during liver surgery.

J Gastrointest Surg, 6 (2002), pp. 569-574

Medline

[17.]

S.G. Delis, J. Madariaga, A. Bakoyiannis, C. Dervenis.

Current role of bloodless liver resection.

World J Gastroenterol, 13 (2007), pp. 826-829

Medline

[18.]

J. Arita, K. Hasegawa, N. Kokudo, K. Sano, Y. Sugawara, M. Makuuchi.

Randomized clinical trial of the effect of a saline-linked radiofrequency coagulator on blood loss during hepatic resection.

Br J Surg, 92 (2005), pp. 954-959

http://dx.doi.org/10.1002/bjs.5108 | Medline

[19.]

F. Burdio, E.J. Berjano, A. Navarro, J.M. Burdio, L. Grande, A. González, et al.

Research and development of a new RF-assisted device for bloodless rapid transection of the liver: computational modeling and in vivo experiments.

Biomed Eng Online, 8 (2009), pp. 6

http://dx.doi.org/10.1186/1475-925X-8-6 | Medline

[20.]

F. Burdio, A. Navarro, E. Berjano, R. Sousa, J.M. Burdio, A. Guemes, et al.

A radiofrequency-assisted device for bloodless rapid transection of the liver: a comparative study in a pig liver model.

Eur J Surg Oncol, 34 (2008), pp. 599-605

http://dx.doi.org/10.1016/j.ejso.2007.05.008 | Medline

[21.]

A. Navarro, F. Burdio, E.J. Berjano, A. Guemes, R. Sousa, M. Rufas, et al.

Laparoscopic blood-saving liver resection using a new radiofrequency-assisted device: preliminary report of an in vivo study with pig liver.

Surg Endosc, 22 (2008), pp. 1384-1391

http://dx.doi.org/10.1007/s00464-008-9793-3 | Medline

[22.]

E.J. Berjano.

Theoretical modeling for radiofrequency ablation: state-of-the-art and challenges for the future.

Biomed Eng Online, 5 (2006), pp. 24

http://dx.doi.org/10.1186/1475-925X-5-24 | Medline

[23.]

F. Burdío, L. Grande, E. Berjano, M.A. Martínez-Serrano, I. Poves, J.M. Burdío, et al.

A new “single-instrument” technique for parenchyma division and hemostasis in liver resection: A clinical feasibility study.

Am J Surg, (2010),

Medline

[24.]

D. Dindo, N. Demartines, P.A. Clavien.

Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey.

Ann Surg, 240 (2004), pp. 205-213

Medline

[25.]

K.S. Haghighi, F. Wang, J. King, S. Daniel, D.L. Morris.

In-line radiofrequency ablation to minimize blood loss in hepatic parenchymal transection.

Am J Surg, 190 (2005), pp. 43-47

http://dx.doi.org/10.1016/j.amjsurg.2005.04.011 | Medline

[26.]

R. Hutchins, M. Bertucci.

Experience with TissueLink– radiofrequency-assisted parenchymal division.

Dig Surg, 24 (2007), pp. 318-321

http://dx.doi.org/10.1159/000103665 | Medline

[27.]

H. Kargozaran, S. Wildendorf, V.P. Khatri.

Radiofrequencyassisted hepatectomy using bipolar Inline multichannel radiofrequency device (ILMRD): report of initial clinical experience.

Hepatogastroenterology, 56 (2009), pp. 1496-1500

Medline

[28.]

M. Pai, L.R. Jiao, S. Khorsandi, R. Canelo, D.R. Spalding, N.A. Habib.

Liver resection with bipolar radiofrequency device: Habibtrade mark 4X.

HPB (Oxford), 10 (2008), pp. 256-260

[29.]

P. Yao, F. Chu, S. Daniel, A. Gunasegaram, T. Yan, W. Lindemann, et al.

A multicentre controlled study of the InLine radiofrequency ablation device for liver transection.

HPB (Oxford), 9 (2007), pp. 267-271

[30.]

L. Vigano, A. Ferrero, E. Sgotto, R.L. Tesoriere, M. Calgaro, L. Capussotti.

Bile leak after hepatectomy: predictive factors of spontaneous healing.

Am J Surg, 196 (2008), pp. 195-200

http://dx.doi.org/10.1016/j.amjsurg.2007.08.062 | Medline

[31.]

D.N. Reed, G.C. Vitale, W.R. Wrightson, M. Edwards, K. McMasters.

Decreasing mortality of bile leaks after elective hepatic surgery.

Am J Surg, 185 (2003), pp. 316-318

Medline

[32.]

P.C. Simmonds, J.N. Primrose, J.L. Colquitt, O.J. Garden, G.J. Poston, M. Rees.

Surgical resection of hepatic metastases from colorectal cancer: a systematic review of published studies.

Br J Cancer, 94 (2006), pp. 982-999

http://dx.doi.org/10.1038/sj.bjc.6603033 | Medline

[33.]

L. Lupo, A. Gallerani, P. Panzera, F. Tandoi, G. Di Palma, V. Memeo.

Randomized clinical trial of radiofrequency-assisted versus clamp-crushing liver resection.

Br J Surg, 94 (2007), pp. 287-291

http://dx.doi.org/10.1002/bjs.5674 | Medline

Indexed in:

Follow us:

Subscribe:

Indexed in:

Follow us:

Subscribe:

Subscribe to our newsletter