A multicentre controlled study of the InLine radiofrequency ablation device for liver transection.
ABSTRACT: BACKGROUND: Surgical resection is the most effective therapy for liver cancer. Intraoperative blood loss during liver resection remains a major concern due to association with higher postoperative complications. The InLine radiofrequency ablation device (ILRFA) has achieved promising results in liver surgery with minimal blood loss and no increase of postoperative complications. In this multicentre controlled study, 108 patients undergoing liver resection were investigated. PATIENTS AND METHODS: A total of 108 patients underwent liver resections in 4 medical centres; the prospective sequential cohort study consisted of 54 ILRFA and 54 ultrasonic surgical aspirator transections as the control group. RESULTS: The type of liver resection performed was very similar in both groups. The median number of RFA deployments was 3 (range 1-12) with a median coagulation time of 9 (range 3-36) min. Median blood loss was 165+/-20 ml (range 5-675) in the ILRFA and 654+/-83 ml (range 80-3600) in the control group (p<0.001). The median transection time was 27 (2-219) min in the ILRFA group and 35 (5-62) min in controls. CONCLUSIONS: Our study indicates that ILRFA device for liver transection is effective in reducing blood loss and is safe. Precoagulation before parenchymal transection appears to be a valid concept in liver surgery. The avoidance of vascular inflow occlusion during parenchymal transection could also be of value.
Project description:Intraoperative blood loss during hepatectomy worsens prognosis, and various tools have been used to improve perioperative safety and feasibility. We aimed to retrospectively evaluate the feasibility and safety of the BiClamp® device for open liver resection.We included 84 patients undergoing liver resection from a single centre, with all patients operated by the same surgical group. All hepatectomies were performed using BiClamp® (Erbe Elektromedizin GmbH, Tubingen, Germany), an electrosurgical device that simultaneously transects liver parenchyma and seals vessels <7 mm in diameter. We collected data on intraoperative blood loss, resection time, and perioperative complications, comparing cirrhotic and non-cirrhotic patients.The 84 patients enrolled in this study included 56 cirrhotic and 28 non-cirrhotic patients. All patients underwent hepatectomy (30 major and 54 minor hepatectomies) using the BiClamp®, exclusively, and 54 patients required inflow occlusion (Pringle manoeuvre). Overall intraoperative blood loss (mean ± standard deviation) was 523.5 ± 558.6 ml, liver parenchymal transection time was 36.3 ± 16.5 min (range, 13-80 min), and the mean parenchymal transection speed was 3.0 ± 1.9 cm2/min. Twelve patients received perioperative blood transfusion. The cost of BiClamp® for each patient was 800 RMB (approximately 109€). There were no deaths, and the morbidity rate was 25%. The mean (standard deviation) hospital stay was 9.3 (2.3) days. Comparisons between cirrhotic and non-cirrhotic patients revealed no difference in blood loss (491.0 ± 535.7 ml vs 588.8 ± 617.5 ml, P = 0.598), liver parenchymal transection time (34.1 ± 14.8 min vs 40.9 ± 19.2 min, P = 0.208), mean parenchymal transection speed (3.3 ± 2.1 cm2/min vs 2.5 ± 1.3 cm2/min, P = 0.217), and operative morbidity (28.6% vs 14.3%, P = 0.147).The reusable BiClamp® vessel-sealing device allows for safe and feasible major and minor hepatectomy, even in patients with cirrhotic liver.This trial was retrospectively registered and the detail information was as followed. Registration number: ChiCTR-ORC-17011873 (Chinese Clinical Trial Registry). Registration Date: 2017-07-05.
Project description:INTRODUCTION: Blood loss and bile leakage are well-known risk factors for morbidity and mortality during liver resection. Bleeding usually occurs during parenchymal transection, and surgical technique should be considered an important factor in preventing intraoperative and postoperative complications. OBJECTIVE: Many approaches and devices have been developed to limit bleeding and bile leakage. The aim of the present study was to determine whether a bipolar vessel sealing device allows a safe and careful liver transection without routine inflow occlusion, achieving a satisfactory hemostasis and bile stasis, thus reducing blood loss and bile leak and related complications. PATIENTS AND METHODS: A total of 50 consecutive patients (24 males, 26 females, with a mean age of 57 years) underwent major and minor hepatic resections using a bipolar vessel sealing device. A clamp crushing technique followed by energy application was used to perform the parenchymal transection. Inflow occlusion was used when necessary to control blood loss but not as a routine. No other devices were applied to achieve hemostasis. RESULTS: The instrument was effective in 45 patients and failed to achieve hemostasis in 5 cases, all of whom had a cirrhotic liver. Median blood loss was 490 ml (range 100-2500 ml) and intraoperative blood transfusions were required in eight cases (16%). Mean operative time was 178 min (range 50-315 min). Inflow occlusion was necessary in 16 (32%) patients. The postoperative complication rate was 24%, with a postoperative hemorrhage in a cirrhotic patient. There was no clinical evidence of bile leak or procedure-related abdominal abscess. CONCLUSION: We conclude that the device is a useful tool in standard liver resection, achieving good hemostasis and bile stasis in patients with normal liver parenchyma, but its use should be avoided in cirrhotic patients.
Project description:Minimizing blood loss is an important aspect of laparoscopic liver resection. Liver transection is the most challenging part of liver resection, but no standard method is available for this step at present. Herein, we have introduced the superficial precoagulation, sealing, and transection (SPST) method, a potentially "bloodless" and "ecofriendly" laparoscopic liver transection technique involving reusable devices: the VIO soft-coagulation system; VIO BiClamp (bipolar electrosurgical coagulation); Olympus SonoSurg (ultrasonic surgical system); and CUSA (ultrasonic aspirator). Furthermore, we have reported the short-term outcomes of laparoscopic liver transection with the SPST method.The study included 14 consecutive patients who underwent laparoscopic partial liver resection with the SPST method at a single institution between August 2008 and June 2010.The median operative time was 201 minutes (range, 97 to 332 min) and the median blood loss was 5 mL (range, 5 to 250 mL). There was no requirement for blood transfusion, no intraoperative complications, and no cases of conversion to open laparotomy. There were no liver transection-related complications such as postoperative bile leakage, bleeding, or infection. All surgical margins were negative, with a mean margin of 4.6 mm, and no local recurrence was observed at an average follow-up of 37.6 months.The SPST method is a simple, efficient, and cost-effective surgical technique for laparoscopic liver resection. It is associated with low intraoperative blood loss and good short-term outcomes. We recommend that the SPST method should be used as a standard technique for laparoscopic liver transection (Supplemental Digital Content 1, http://links.lww.com/SLE/A103).
Project description:BACKGROUND: Bleeding during liver transection remains a potential hazard. This study aims to report the efficacy and complications of in-line radiofrequency ablation (ILRFA)-assisted liver resection. PATIENTS AND METHODS: The blood loss of 25 consecutive patients who underwent ILRFA-assisted liver resection was obtained by weighing swabs and measuring suction jar contents during liver resection and calculated in ml per cm(2) of the transection surface area. Postoperative complications were recorded. Five clinical variables, which might affect blood loss, were analyzed. RESULTS: The mean blood loss during parenchymal dissection for the ILRFA group was 3.4+/-3.2 ml/cm(2). Three patients had intra-abdominal collections, including one patient with bile leakage after ILRFA-assisted liver resection. Age, gender, extent of liver resection, liver quality and Pringle maneuver did not demonstrate significant impact on blood loss. CONCLUSIONS: This study showed that ILRFA-assisted liver resection was associated with very low blood loss. This is likely to improve the operative safety of liver resection for hepatic tumors. There were no significant postoperative sequelae.
Project description:Parenchymal transection represents a crucial step during liver surgery and many different techniques have been described so far. Stapler resection is supposed to be faster than CUSA resection. However, whether speed impacts on the inflammatory response in patients undergoing liver resection (LR) remains unclear.This is a randomized controlled trial including 40 patients undergoing anatomical LR. Primary endpoint was transection speed (cm2/min). Secondary endpoints included the perioperative change of pro- and anti-inflammatory cytokines, overall surgery duration, length of hospital stay, morbidity and mortality.Mean transection speed was significantly higher in patients undergoing stapler hepatectomy compared to CUSA resection (CUSA: 1 (0.4) cm2/min vs. Stapler: 10.8 (6.1) cm2/min; p<0.0001). Analyzing the impact of surgery duration on inflammatory response revealed a significant correlation between IL-6 levels measured at the end of surgery and the overall length of surgery (p<0.0001, r = 0.6188). Patients undergoing CUSA LR had significantly higher increase of interleukin-6 (IL-6) after parenchymal transection compared to patients with stapler hepatectomy in the portal and hepatic veins, respectively (p = 0.028; p = 0.044). C-reactive protein levels on the first post-operative day were significantly lower in the stapler cohort (p = 0.010). There was a trend towards a reduced overall surgery time in patients with stapler LR, especially in the subgroup of patients undergoing minor hepatectomies (p = 0.020).Liver resection using staplers is fast, safe and suggests a diminished inflammatory response probably due to a decreased parenchymal transection time.ClinicalTrials.gov NCT01785212.
Project description:BACKGROUND: Intraoperative blood loss has been shown to be an important factor correlating with morbidity and mortality in liver surgery. In spite of the technological advances in hepatic parenchymal transection devices, bleeding remains the single most important complication of liver surgery. The role of radiofrequency (RF) in liver surgery has been expanded from tumour ablation to major hepatic resections in the last decade. Habib 4X, a new bipolar RF device designed specifically for liver resection is described here. METHODS: Habib 4X is a bipolar, handheld, disposable RF device and consists of two pairs of opposing electrodes which is introduced perpendicularly into the liver, along the intended transection line. It produces controlled RF energy between the electrodes and the heat produced seals even major biliary and blood vessels and enables resection of the liver parenchyma with a scalpel without blood loss or biliary leak. RESULTS: Three hundred and eleven patients underwent 384 liver resections from January 2002 to October 2007 with this device. There were 109 major resections and none of the patients had vascular inflow occlusion (Pringle's manoeuvre). Mean intraoperative blood loss was 305 ml (range 0-4300) ml, with less than 5% (n=18) rate of transfusion. CONCLUSION: Habib 4X is an additional device for hepatobiliary surgeons to perform liver resections with minimal blood loss and low morbidity and mortality rates.
Project description:INTRODUCTION: Recently, there are various kinds of parenchymal transection methods. The aim of this study is to evaluate the usefulness of the Kelly clamp crushing technique compared to ultrasonic dissector during hepatic resection. MATERIALS AND METHODS: Comparisons between 10 ultrasonic dissector group and 10 Kelly clamp crushing technique group were performed by using nine items (transaction time, right lobe volume, perioperative transfusion, total bilirubin (TB), aspartate aminotransferase (AST), alanine aminotransferase (ALT), hospital stay, postoperative morbidity, in-hospital mortality). RESULTS: The mean transection time in the Kelly clamp crushing technique group was 27+/-15.5 mins (range 15-60) and was 48+/-7.1 mins (range 35-60) in the ultrasonic dissector group (p<0.05), and no patients received transfusion in both groups. CONCLUSIONS: Since the Kelly clamp crushing technique shortens operative time and there is no significant difference in blood loss and in results of liver function tests compared to using the ultrasonic dissector, we propose that the Kelly clamp crushing technique should be considered as a standard method of liver resection.
Project description:BACKGROUND: Control of intraoperative hemorrhage represents a significant challenge in hepatic surgery, particularly during resection of large, hypervascular hepatic hemangiomata (HH). Various devices to minimize blood loss from hepatic parenchymal transection are currently under investigation. Herein, we present our experience with a radiofrequency (RF)-powered multiarray for resection of HH. PATIENTS AND METHODS: From September 2005 to January 2006, we conducted a retrospective review of our hepatobiliary database to identify patients with symptomatic giant cavernous HH undergoing resection with a RF multiarray device. The purpose of this review was to assess the technical aspects of using RF energy to assist in the resection of HH. RESULTS: The extent of operation varied depending on the size and location of the tumor. Two patients underwent two atypical subsectionectomies and two underwent trisectionectomies. The Habib sealer provided a safe and effective method for hepatic parenchymal transaction. No patients required blood transfusion, and no injuries to major biliary or vascular strictures were observed at 1 year follow-up. A seroma developed in one patient 6 months postoperatively, but was drained percutaneously. CONCLUSIONS: Hepatic parenchymal transection with the Habib sealer device is a feasible approach to resect HH. Further study is needed to objectively compare the efficacy of RF-assisted parenchymal transection with that of traditional parenchymal transection techniques.
Project description:BACKGROUND: The aim of the present study was to evaluate the feasibility and efficacy of the LigaSure vessel sealing system on a large scale when used for liver resection. METHODS: We retrospectively analyzed the short-term outcomes of 277 patients undergoing hepatectomies with the use of the LigaSure system. RESULTS: There were two hospital deaths (0.7%), and the morbidity rate was 25.3%. Mean blood loss during liver transection was 352+/-422 ml, and the liver transection speed was 1.9+/-0.86 cm(2)/min. The number of ties required during liver transection was 13.2+/-13. The morbidity and mortality rate was similar when comparing patients with injured livers (chronic hepatitis or cirrhosis) and those with normal livers, but liver transection speed was faster in those with normal livers when compared with those with injured livers (2.00+/-0.88 vs. 1.57+/-0.63 cm(2)/min, p=0.001). CONCLUSIONS: The LigaSure system can be applied safely in patients undergoing liver resection, regardless of whether cirrhosis is present or not.
Project description:The anterior approach (AA) technique has been reported to provide better operative and survival outcomes compared with the conventional approach for large right hepatocellular carcinoma (HCC) resection. However, this technique runs the risk of massive retrograde bleeding from the right hepatic vein or middle hepatic vein at the deeper plane of parenchymal transection. This study was designed to evaluate the efficacy of AA combined with infrahepatic inferior vena cava (IVC) clamping on the perioperative outcomes in patients undergoing right hepatic resection for large HCC in randomized clinical trial settings.A total of 101 patients undergoing right hepatic resection for large HCC were randomized to receive AA combined with infrahepatic IVC clamping (group A, n = 50), or AA alone (group B, n = 51).The total blood loss (423 ± 154 vs 757 ± 338 mL; P = 0.001), blood loss during liver transection (272 ± 96 vs 563 ± 144 mL; P = 0.001), and intraoperative blood transfusion requirements (12.0% vs 29.4%; P = 0.031) were significantly less in group A patients compared with group B patients. There was no IVC clamping-associated morbidity in group A.AA combined with infrahepatic IVC clamping for large right HCC resection is a safe, feasible, and effective technique in reducing intraoperative blood loss.