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Liver Resection by Use of an Incremental Bipolar Radiofrequency Generator and Six-Needle In-Line Comb

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Liver Resection by Use of an Incremental Bipolar Radiofrequency Generator and Six-Needle In-Line Comb Liver resection by use of an incremental bipolar radiofrequency generator and six-needle in-line comb. P. Rossi, A. De Majo, A. L. Gaspari General Surgery Division, Tor Vergata University, Rome Tor Vergata Polyclinic, PTV Director Prof. A.L. Gaspari Introduction Progress in surgical techniques, in anaesthesia, better knowledge of anatomy and hepatic physiology allow, in expert hands, resectional surgery with low mortality and reduced morbidity. However, intra-operative blood loss remains the main problem, being associated with increased post-operative morbidity and reduced long-term survival (1,2). In order to reduce bleeding, many manoeuvres, have been perfected: Pringle, total vascular exclusion, reduction of central venous pressure (3,4,5). To the same end, many devices have been developed and many studies carried out with a view to comparing these with the standard kelly- clasia technique (clamp-crushing technique), with uneven results (6 – 16). In 2002, Habib described an innovative technique with monopolar radiofrequency (RF) to effect “wedge” resections with minimal blood loss (17). It consists of coagulating the hepatic parenchyma around the tumour with a “cooled-tip” monopolar needle so as to allow transection by common scalpel. Subsequently described in major liver resections (18), this technique is commonly indicated as “Radio-frequency assisted liver resection” (RFA-LR). After wide experience in the use of radiofrequency thermo-ablation of primitive and secondary liver tumours (19,20,21), we started an experimental study, in collaboration with engineers of the LED S.p.a. company (Aprilia, Roma), first on “ex vivo” pig liver and then on “in vivo” animals, that led to the realization of an innovative apparatus consisting of a incremental bipolar radiofrequency generator and six-needle in-line comb (22,23) . In this report we wish to explain the results of the use of this apparatus in the clinical setting in eleven patients, of which the first six made up a pilot study. Materials and Methods Generator The apparatus, named Surtron SB, consists of a incremental bipolar radiofrequency generator and six-needle in-line comb (figure 1) with a frequency of 470 KHz, power 150 W, 160 1 volts that, through five bipolar circuits, simultaneously supplies a probe known as the comb (figure 2) consisting of six 1.5 mm diameter electrode needles spaced at 6 mm intervals. The energy to be delivered is automatically determined according to the tissue impedance between the two central electrodes and is correlated to the thickness of the liver. Each electrode is automatically switched out when the current reaches 50% of the previous maximum value and this corresponds to a valid coagulation of the parenchyma. This algorithm was studied experimentally in the “in vivo” animal model by means of correlation between the level of coagulation as evaluated by the surgeon and the current flow curve. The term incremental refers to the fact that the current flowing between two adjacent electrodes is not the sum, as in traditional apparatus, but the difference. Therefore, each electrode receives a higher voltage than the preceding electrode (incremental mode). The electrodes are coated with a layer of NbN and CrN in order to avoid adhesion of the coagulated tissue and thus easing removal of the comb. A special plastic device has been realized for protection of the surgeon and of surrounding organs during the introduction of the probe and the supply of power (figure 3). Handpiece 2 Protection shield Our technique consists of two parallel applications of the comb; the first (figure 4) determines a “slice” of coagulation about 1.2 mm width and alongside this, the second produces a further 6mm of necrosis (fig 5). The transection of the parenchyma is performed with a common scalpel along this second line and leaving in situ a portion of necrotic tissue about 1 cm thick (fig 6). We prefer to coagulate and section with the “step by step” technique rather than carry out the coagulation of the entire intended plane. During the transection, the separation of the edges and the blunt dissection manoeuvres allow, when necessary, isolation and closure of intra-parenchymal vascular structures by means of clips or ligatures. 3 First line of coagulation 4 Second line of coagulation 5 Parenchymal section After approval by the Tor Vergata Polyclinic Ethical Committee, we realized a clinical pilot study in six patients, primarily with a view to evaluating safety and tolerability, and secondarily the efficacy of the thermo-coagulation of the liver parenchyma by means of our apparatus in liver resections for tumours. To that end we enlisted 6 patients affected by hepatic tumour suitable for resection. In each case we carried out careful exploration of the peritoneal cavity in order to exclude the presence of extra-hepatic involvement, local colonic recurrence and peritoneal carcinomatosis. The liver was mobilized in relation to the intervention to be carried out and underwent intra-operative ultrasonography (Hitachi H19 with EUP – 053T intra-operative probe) to confirm the lesions, their number, position, relationship with the principal vascular structures and the eventual presence of nodules not revealed by the pre-operative imaging. The safety and tolerability (primary aim) were investigated through the evaluation of: a) The post-operative coagulation parameters (TAP, PTT and D-Dimers); b) The blood flow of the glissonian vessels and hepatic veins using intra- and post- operative Echo-Colour-Doppler; c) Parameters of hepatic function; d) Cardio-respiratory monitoring. In order to study the efficacy (secondary aim), the following were evaluated: a) Intra-operative blood loss; b) correct cicatrisation of the edge (absence of post-operative biliary and blood collections; After the pilot study we operated with this technique on another 5 patients (overall period June 2005 - February 2007; M=10, F=1; age-range 37-75 years). Pre-operative work-up, both laboratory and radiological, was the usual for liver neoplasms, while peri- and post-operative consisted of blood count, laboratory and coagulative tests in the first, third 6 and seventh post-operative days, and after one and three months; liver ultrasonography and echo- colour Doppler in the first and seventh days and after one and three months; tumour markers after one month; out-patient checks after 15 days and one and three months; radiology checks (CT and/or MR with contrast medium) after three months. A total of 8 patients were affected by liver metastases from colorectal cancer; 2 patients had suspected gallbladder tumour whose definitive histopathology indicated carcinoma in one case and chronic cholecystitis in the other; 1 patient was affected by a suspected intra-hepatic cholangiocarcinoma that at the definitive histological examination turned out to be post-infarction necrosis. In the group of patients with metastatic disease of the liver, 2 were affected by a single lesion, 4 by two and 2 by three. 3 left lobectomies, one left hepatectomy, 3 right hepatectomies, one right lateral sectorectomy, 4 wedge resections and 2 resections of the gall bladder bed were carried out. In 3 patients, in association with the resection, monopolar RF ablation with one metastasis was carried out; in another 3 patients, one intestinal ileo-colic anastomosis, one total colectomy with splenectomy, one a closure of ileostomy were respectively carried out. Vascular control of the inflow vessels was carried out in all of the formal resections those of a patient undergoing left lobectomy and a patient undergoing a right lateral sectorectomy. The hepatic veins were divided by an EndoGIA laparoscopic stapler. The Pringle manoeuvre was never carried out. The parenchymal transection was executed with a common scalpel along the necrotic plane obtained by means of the two parallel applications of the probe. In close proximity to the hilus elements, the vena cava or hepatic veins, the transection was effected using kelly-clasia. The liver edge was never treated with argon or substances facilitating haemostasis. TABLE Pz Pre-op N° Surgical procedure Vascular Post-op Complication Trtasfusion diagnosis lesions Control diagnosis 1 meta 1 Left hepatectomy Portal and meta no 0 sovrahepatic vein 2 meta 3 Left lobectomy Portal meta Collection with 0 wedge 7° spontaneous RF 8° resolution 3 Gallbladder resections of the gall bladder no cholecystitis no 1 U carcinoma bed haematoma of the abdominal wall 4 Cholangio- Left lobectomy no post- 0 carcinoma infarction necrosis 5 meta 2 Left lobectomy Portal meta no 0 RF 8° Ileo-colic anostomosis 6 meta 3 Wedge resection no meta no 0 total colectomy, with ileo- rectum anastomosis 7 meta 1 Right Hepatectomy Portal meta no 0 closure of ileostomy and terminal colostomy 8 meta 2 Resection of VI + VII seg. no meta no 0 RF 4° 9 meta 2 Right Hepatectomy Portal meta Collection with 0 percutaneous drainage 11 Gallbladder resections of the gall bladder no carcinoma no 0 carcinoma bed 7 Results Neither gaseous embolisms nor thromboses of the hepatic veins were found. The use of our apparatus did not bring about repercussions on the cardiac-respiratory functions. Coagulation time for each application of the comb, excluding vascular control, was about 3 minutes for the first and about 1 minute for the parallel one; about 1 minute for the first and 45 seconds for the second wherever closure of the relative portal and arterial branch was carried out. Each application of the probe determined a necrotic “slice” of about 3.5 cm length, about 1-1.2 cm width, and depth equal to that of the insertion of the electrode needles. Transaminases, to be correlated to the parenchymal necrosis, were normalized on average in the seventh day, analogically to that verified with ablation through monopolar RFA of the neoplastic nodules; D-dimers were normalized on average within one month. Blood losses during the transectional phase were between 30 and 50 cc.
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