- Email: [email protected]
The Use of Saline-Linked Radiofrequency Dissecting Sealer for Liver Transection in Patients With Cirrhosis
Journal of Surgical Research 149, 110 –114 (2008) doi:10.1016/j.jss.2008.01.002
The Use of Saline-Linked Radiofrequency Dissecting Sealer for Liver Transection in Patients With Cirrhosis Feng Xia, M.D., Ph.D.,1 Shuguang Wang, M.D., Ph.D., Kuansheng Ma, M.D., Ph.D., Xiaobing Feng, M.D., M.S., Yongjie Su, M.D., and Jiahong Dong, M.D., Ph.D. Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University, Chongqing, China Submitted for publication July 2, 2007
Background. In patients with cirrhosis excessive hemorrhage and the need for blood transfusion are associated with increased postoperative morbidity and mortality as well as a poor long-term outcome. Saline-linked radiofrequency dissecting sealer (TissueLink) is a recent advance in technology that improves hemostasis during difficult liver resections. Preliminary studies have shown that this technique reduces blood loss without inflow occlusion. Patients and methods. A controlled study was performed on 122 consecutive patients with cirrhosis who underwent liver resection for hepatocytotic carcinoma. The outcomes of liver transection with clamp crushing and TissueLink were compared to evaluate which strategy is most beneficial to the patients. Results. Both intraoperative blood loss and blood transfusion requirements were significantly higher in the crushing clamp group than in the TissueLink group (P ⴝ 0.047 and P ⴝ 0.031, respectively). In addition, a significantly higher number of patients required a blood transfusion in the crushing clamp group (P < 0.001). However, the transection time was significantly faster in the crushing clamp group than in the TissueLink group (P < 0.001). The number of patients that required Pringle’s maneuver was markedly higher in the crushing clamp group (P < 0.001). In addition, the hemostasis time was significantly longer in the crushing clamp group (P < 0.001). The serum aspartate aminotransferase levels 3 and 7 days after surgery were significantly higher in the crushing clamp group than in the TissueLink group (P ⴝ 0.035 and P ⴝ 0.003, respectively). Serum total bilirubin levels were markedly increased 3 days after surgery in 1
To whom correspondence and reprint requests should be addressed at Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University, Chongqing, 400038 China. E-mail: [email protected].
0022-4804/08 $34.00 © 2008 Elsevier Inc. All rights reserved.
the crushing clamp group than in the TissueLink group (P ⴝ 0.011). Biliary leakage occurred in a higher number of crushing clamp patients (six) than TissueLink patients (three), although this difference was not significant. The operative morbidity not including biliary leakage was higher in the crushing clamp group than the TissueLink group (nine patients versus five patients, respectively). Conclusion. This study reveals that the TissueLink procedure has beneficial effects during liver transection under cirrhotic conditions in terms of blood loss and reperfusion-related liver injury. However, this procedure requires a significantly longer transection time of the parenchyma. © 2008 Elsevier Inc. All rights reserved. Key Words: saline-linked radiofrequency dissecting sealer; liver transection; cirrhosis; hepatocellular carcinoma. INTRODUCTION
Liver cirrhosis related to hepatitis B is very common in Southeast Asia, especially in China. Approximately 20% of patients with cirrhosis could potentially develop hepatocytotic carcinoma (HCC). The cirrhotic liver usually has a poor hepatic function reserve that can lead to heavy bleeding due to portal hypertension during transection of the hepatic parenchyma. Therefore, patients would benefit greatly from a technique that allows surgery to be performed with limited or no inflow occlusion and minimal blood loss. Liver transection procedures have been improved gradually and progressively in the past two decades [1–3]. Technical innovations have mainly focused on minimizing bleeding during transection since excessive hemorrhage and the need for blood transfusion are associated with increased postoperative morbidity and mortality, as well as a poor long-term outcome. The
110
XIA ET AL.: USING TISSUELINK FOR LIVER TRANSECTION IN CIRRHOTIC PATIENTS
clamp crushing method with Pringle’s maneuver has been used since the early 20th century to prevent bleeding during parenchyma transection. However, inflow occlusion could lead to hepatic ischemia reperfusion injury, especially in patients with cirrhosis [4]. In recent years, the crushing clamp technique has been used clinically with the ultrasonic dissector (Cavitron Ultrasonic Surgical Aspirator, CUSA), water jet dissector, harmonic scalpel, and microwave coagulator. Each device has its own advantages, but to date there is no agreement as to which method is the most beneficial treatment for hepatectomy [5–7]. Hepatectomy and liver transplantation are still considered to be the best choice of treatment for HCC. Hepatectomy remains the main intervention for HCC with cirrhosis, due to a deficient liver donor pool. Thus, many surgeons face the problem of how to perform liver transection under cirrhotic conditions [8 –10]. Saline-linked radiofrequency dissecting sealer (TissueLink medical’s DS3.5) is a recent advance in technology that reportedly improves hemostasis during difficult liver resections and reduces blood loss without inflow occlusion [7]. TissueLink has been used as a routine procedure for liver resection in our Institute since 2004. We have recently carried out a controlled study on hepatectomy in 122 consecutive patients using different devices. The outcomes of liver transection with clamp crushing or TissueLink were compared to evaluate which strategy is most beneficial to cirrhotic patients. PATIENTS AND METHODS A controlled study was performed on 122 consecutive patients with cirrhosis who underwent liver resection between August 2004 and May 2007 for HCC in the Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University (China). The study protocol was approved by the local ethic board of Southwest Hospital. Written informed consent was obtained from all patients before their participation in the study. One team of liver surgeons performed all of the surgeries. The clinical data of each patient were recorded prospectively in a computerized database. All patients followed the same preoperative evaluation protocol including blood biochemistry, percutaneous ultrasonography, spiral computed tomography of the abdomen and computed tomography angiography of the hepatic artery, hepatic vein, and portal vein, chest X-ray, and electrocardiogram. Liver function was assessed by Child’s–Pugh grading, the oral glucose tolerance test, and the indocyanine green clearance test. During the study period, clamp crushing and TissueLink were selected for hepatic resection for HCC. The surgery started with a right subcostal incision or midline incision with a right horizontal extension. Intraoperative ultrasonography was performed routinely to delineate the extent of tumor involvement, to detect tumor nodules in the contralateral lobe and invasion of the tumor into major blood vessels, and to plan and mark the plane of parenchymal transection [11]. Liver hilar dissection was performed and the right or left hepatic artery and portal vein were controlled for anatomical hemihepatectomy. The right lobe of the liver together with the tumor was then completely mobilized from the posterior abdominal wall and rotated anteriorly and to the left to allow separation of the liver from the inferior vena cava [12]. All of the small caval venous branches were individually ligated and divided. The right hepatic
111
vein was then isolated outside the liver, clamped, divided, and sutured before liver transection. Similarly, the falciform ligament and left triangular ligament were also dissected for the mobilization of the left lobe before the liver parenchyma was separated. The low central venous pressure approach was used in all patients. Blood transfusion was launched when hemoglobin levels were lower than 8.0 g/L. An intermittent Pringle’s maneuver consisting of a 5-min break after 15-min occlusion was routinely used with the crushing clamp technique but seldom used during the few cases of marginal resection (mini-volume near the edge). Inflow occlusion was achieved using the tourniquet technique around the portal triad with a 4-mm tape. Liver transection was carried out using parenchyma crushing with a Kelly clamp. All clamped structures including the major intrahepatic bile ducts were ligated or sutured [13, 14]. An alternative procedure for hepatic transection was performed using a saline-linked radiofrequency dissecting sealer. The monopolar device was connected to a compatible electrosurgical generator (Force FX-8C; Valleylab, Tyco Healthcare, Boulder, CO), with an output power set at 70 W. Radiofrequency (480 KHz) energy was focused at the tip and conveyed into the liver tissue by a low flow of saline solution (one drop per second) through a channel inside the device to the tip to induce thermocoagulation of the liver tissue. The continuous flow of saline also cooled the tissue surface at a temperature below 100°C to prevent charring and escar formation. The pointed tip of the cone-shaped dissector allowed dissection of the liver parenchyma after coagulation without the need for clamp crushing. Small vessels (⬍3 mm in diameter) were simply sealed using the dissecting sealer and divided. Larger vessels were ligated and divided. In all patients, hepatic transection was performed without Pringle’s maneuver unless heavy bleeding occurred. A combination of an ultrasonic dissector (CUSA; 23 kHz standard tip, cauter 70 W, flush 4 mL/min, sensitivity 100%) and TissueLink was used for parenchyma transection around the main bile duct for preventing bile duct injury. The CUSA was used predominantly for breaking the parenchyma, sucking out the slush, and presenting the vessel. All patients received the same postoperative care by the same team of surgeons and were nursed in the intensive care unit during the early postoperative course. Parenteral nutritional support was provided for patients with liver cirrhosis. Early enteric nutrition was encouraged once bowel activity returned. All intraoperative and postoperative complications were recorded prospectively. Biliary leakage was diagnosed when the total bilirubin level in the drainage fluid exceeded 85 mol/L 7 days after surgery. Major biliary leakage was diagnosed when the drain could be removed at least 2 weeks after surgery, or when either relaparotomy or percutaneous drainage was required. Hospital death was defined as death during the hospital stay due to the hepatic resection. Statistical analysis was performed using the 2 test or the Fisher exact test to compare discrete variables, and the Mann–Whitney test was used to compare continuous variables. P ⬍ 0.05 was considered to be statistically significant. Statistical analyses were performed with SPSS 10.0 for Windows computer software (SPSS Inc., Chicago, IL).
RESULTS
Of the 122 patients with cirrhosis that underwent hepatic resection for HCC, 61 patients were treated using the crushing clamp technique and 61 patients were treated using the TissueLink method. The clinical and laboratory data were compared between the two groups (Table 1). There were more men in each group. However, there were no significant differences between the two groups. The intraoperative clinical parameters were compared between the two groups (Table 2). The intraop-
112
JOURNAL OF SURGICAL RESEARCH: VOL. 149, NO. 1, SEPTEMBER 2008
TABLE 1
TABLE 3
Clinical and Laboratory Data
Postoperative Outcome Data
Clinical parameters
Crushing clamp
TissueLink
Pa
Clinical parameters
Crushing clamp
No. of patients Male Age (yr) b Platelet count (10 9/L) b Serum AFP (ng/mL) b Serum albumin (g/L) b Serum total bilirubin (mol/L) b AST (IU/L) b Hemoglobin (g/L) b ICG retention at 15 min (%) b Child–Pugh grade A B Tumor size (mm) b Type of resection Minor Major c
61 50 48 (29–77) 164 (32–345) 433 (2.8–23,974) 34 (24–52)
61 47 51 (27–75) 124 (41–310) 326 (7.7–15,523) 36 (26–51)
— 0.654 0.203 0.263 0.099 0.358
246 (34–1569) 104 (12–1124)
112 (58–864) 0.035 32 (15–168) 0.003
132 (18–434)
48 (25–154) 0.011 0.491 2 1
17 (8–54) 54 (14–528) 11.3 (6–17.4)
14 (5–48) 61 (12–496) 10.5 (5.9–16.8)
0.325 0.679 0.372
11.4 (1.8–35.7)
12.1 (4.6–36.2)
0.381 0.678
Serum AST on day 3 (IU/L) Serum AST on day 7 (IU/L) Serum total bilirubin on day 3 (mol/L) Biliary leakage Minor Major Operative morbidity not including biliary leakage Minor Major Hospital stay (days) Hospital deaths
44 17 57 (13–149)
47 14 49 (11–148)
22 39
a
3 3
Pa
TissueLink
0.395 5 4 16 (9–42) 2
4 1 14 (9–32) 0
0.216 —
Crushing clamp group compared with TissueLink group.
0.191 0.271
29 32
AFP ⫽ alpha fetoprotein; AST ⫽ aspartate aminotransferase; ICG ⫽ indocyanine green. a Crushing clamp group compared with TissueLink group. b Value expressed in median with range in parentheses. c Major hepatectomy was defined as ⱖ3 segments.
erative blood loss and blood transfusion requirement were both significantly higher in the crushing clamp group than in the TissueLink group (P ⫽ 0.047 and P ⫽ 0.031, respectively). In addition, a significantly higher number of crushing clamp patients required blood transfusion than TissueLink patients (P ⬍ 0.001). However, the transection time was significantly faster in the crushing clamp group than in the TissueLink group (P ⬍ 0.001). The number of patients that required the Pringle’s maneuver was markedly increased in the crushing clamp group (P ⬍ 0.001). The hemostasis time was significantly longer in the crushing clamp group (P ⬍ 0.001). The postoperative outcome was compared between the two groups (Table 3). The serum aspartate aminotransferase (AST) levels 3 and 7 days after surgery
were significantly higher in the crushing clamp group than in the TissueLink group (P ⫽ 0.035 and P ⫽ 0.003, respectively). However, by day 7, the serum AST levels in the crushing clamp group were similar to those levels observed in the TissueLink group on day 3. Serum total bilirubin levels on day 3 were markedly higher in the crushing clamp group than in the TissueLink group (P ⫽ 0.011). The surgical complication rate was compared between the two groups (Table 3). Biliary leakage occurred in more patients from the crushing clamp group (six patients) than the TissueLink group (three patients), although this difference was not statistically significant. The operative morbidity not including biliary leakage was higher in the crushing clamp group than the TissueLink group (nine patients versus five patients, respectively). Minor complications that occurred in the clamp crushing patients included ascites (two patients), incision infection (two), and ileus (one). Major complications such as postoperative bleeding (two patients), intra-abdominal sepsis (one patient), and total incision dehiscence (one patient) were also observed in the crushing clamp group. The hospital stay appeared to be longer in the crushing clamp
TABLE 2 Intraoperative Outcome Data Clinical parameters
Crushing clamp
TissueLink
Pa
Intraoperative blood loss (mL) b Intraoperative blood transfusion (mL) b No. of patients without transfusion (%) Transection time (min) b No. of patients with Pringle (%) Hemostasis time (min) b
750 (150–6800) 950 (0–6500) 25 (41.0%) 32 (8–102) 53 (86.9%) 25 (8–48)
350 (40–2000) 600 (0–1500) 54 (88.5%) 85 (20–182) 7 (11.5%) 4 (0–12)
0.047 0.031 ⬍0.001 ⬍0.001 ⬍0.001 ⬍0.001
a b
Crushing clamp group compared with TissueLink group. Value expressed in median with range in parentheses.
XIA ET AL.: USING TISSUELINK FOR LIVER TRANSECTION IN CIRRHOTIC PATIENTS
group, although this difference was not significant. Two hospital deaths occurred in the crushing clamp group due to liver failure (one patient) and heavy postoperative bleeding (one patient). DISCUSSION
TissueLink is a new device used clinically for hepatectomy in a few centers worldwide. The benefits of this technique have not been widely confirmed. This study reveals that TissueLink has beneficial effects during liver transection in cirrhotic patients with respect to blood loss and reperfusion-related liver injury. However, this procedure results in a significantly longer transection time of the parenchyma. Liver cirrhosis reduces the ability of the liver to endure anoxemia. The conventional approach for liver transection using a crushing clamp requires the Pringle’s maneuver for reducing intraoperative blood loss. Thus, the development of a new approach for transection without occlusion of liver inflow would benefit from the restoration of postoperative hepatic function [3, 4, 7, 15]. Our study revealed that the benefits of the TissueLink procedure included its ability to decrease the use of the inflow occlusion, which reduces the intraoperative blood loss and ischemia-reperfusion injury. Three previous studies have also assessed the benefits of a saline-linked radiofrequency dissecting sealer in hepatic resection and in two cases reduced blood loss was reported. Sakamoto et al. reported that the use of a Floating Ball (Tissue Link Medical) device significantly reduced the amount of blood loss during liver transection compared with that observed with the crushing clamp method (median 200 mL versus 480 mL) [16]. The Floating Ball has the same mechanism as the TissueLink (DS 3.5), although its tip shape is different. Sturgeon et al. reported a mean blood loss as low as 165 mL during liver parenchymal division with use of the Floating Ball [17]. The reason a third randomized clinical trial did not reveal beneficial effects in terms of blood loss might be due to the differences in patients included in the study. Of 80 patients that were divided equally into dissecting sealer and crushing clamp groups, 9 patients in the dissecting sealer group had cirrhosis compared to 12 in the crushing clamp group. Most of the patients (21/80) did not suffer with cirrhosis, a condition that might cause more blood loss due to portal hypertension [18]. Another advantage of the TissueLink method observed in this study was that its sealing effect decreased biliary leakage and other morbidity as described previously. The TissueLink procedure often resulted in a prolonged transection time, indicating that this procedure requires more patience and skill by the operator. For example, heavy bleeding might occur if the parenchyma is dissected before the mini vessels have coagulated properly. Previous studies have also reported
113
that use of TissueLink increases the operating time and causes a greater increase in the serum AST level than the clamp crushing method for hepatic resection [16 –19]. In this study, the serum AST level increased significantly postoperatively possibly due to scalding of the liver parenchyma. However, its injury was markedly lower than that associated with ischemiareperfusion injury, and the AST level recovered very rapidly compared to that observed in the crushing clamp group. In conclusion, TissueLink is the preferred procedure for liver transection in patients with cirrhosis, because its use leads to improved surgical outcomes. Further studies, ideally in a prospective randomized clinical trial, are required to document the advantages of TissueLink as a routine technique for all hepatic resections including those under cirrhotic conditions.
REFERENCES 1.
Shi M, Guo RP, Lin XJ, et al. Partial hepatectomy with wide versus narrow resection margin for solitary hepatocellular carcinoma: A prospective randomized trial. Ann Surg 2007;245:36.
2.
Fortner JG, Kim DK, Maclean BJ, et al. Major hepatic resection for neoplasia: Personal experience in 108 patients. Ann Surg 1978;188:363.
3.
Fan ST, Lo CM, Liu CL, et al. Hepatectomy for hepatocellular carcinoma: Toward zero hospital deaths. Ann Surg 1999;229: 322.
4.
Tanaka S, Noguchi N, Ochiai T, et al. Outcomes and recurrence of initially resectable hepatocellular carcinoma meeting milan criteria: Rationale for partial hepatectomy as first strategy. J Am Coll Surg 2007;204:1.
5.
Marrero JA, Pelletier S. Hepatocellular carcinoma. Clin Liver Dis 2006;10:339.
6.
Benzoni E, Lorenzin D, Baccarani U, et al. Resective surgery for liver tumor: A multivariate analysis of causes and risk factors linked to postoperative complications. Hepatobiliary Pancreat Dis Int 2006;5:526.
7.
Poon RT, Fan ST, Wong J. Liver resection using a saline-linked radiofrequency dissecting sealer for transection of the liver. J Am Coll Surg 2005;200:308.
8.
Fan ST, Lai EC, Lo CM, et al. Hospital mortality of major hepatectomy for hepatocellular carcinoma associated with cirrhosis. Arch Surg 1995;130:198.
9.
Makuuchi M, Takayama T, Kubota K, et al. Hepatic resection for hepatocellular carcinoma: Japanese experience. Hepatogastroenterology 1998;45:1267.
10.
Takenaka K, Kawahara N, Yamamoto K, et al. Results of 280 liver resections for hepatocellular carcinoma. Arch Surg 1996; 131:71.
11.
Couinaud C. Le Foie. Etudes Anatomiques et Chirurgicales. Paris: Masson, 1957.
12.
Chen XP, Qiu FZ, Wu ZD, et al. Hepatectomy for huge hepatocellular carcinoma in 634 cases. World J Gastroenterol 2006; 12:4652.
13.
Xia F, Poon RT, Fan ST, et al. Thoracoabdominal approach for right-sided hepatic resection for hepatocellular carcinoma. J Am Coll Surg 2003;196:418.
114 14.
JOURNAL OF SURGICAL RESEARCH: VOL. 149, NO. 1, SEPTEMBER 2008
John AR, Khan S, Mirza DF, et al. Multivariate and univariate analysis of prognostic factors following resection in HCC: The Birmingham experience. Dig Surg 2006;23:103. 15. Le Treut YP, Hardwigsen J, Ananian P, et al. Resection of hepatocellular carcinoma with tumor thrombus in the major vasculature. A European case-control series. J Gastrointest Surg 2006;10:855. 16. Sakamoto Y, Yamamoto J, Kokudo N, et al. Bloodless liver resection using the monopolar Floating Ball plus LigaSure diathermy: preliminary results of 16 liver resections. World J Surg 2004;28:166.
17.
Sturgeon C, Helton WS, Lamba A, et al. Early experience employing a linear hepatic parenchyma coagulation device. J Hepatobiliary Pancreat Surg 2003;10:81. 18. Arita J, Hasegawa K, Kokudo N, et al. Randomized clinical trial of the effect of a saline-linked radiofrequency coagulator on blood loss during hepatic resection. Br J Surg 2005;92: 954. 19. Geller DA, Tsung A, Maheshwari V, et al. Hepatic resection in 170 patients using saline-cooled radiofrequency coagulation. HPB 2005;7:208.
The Use of Saline-Linked Radiofrequency Dissecting Sealer for Liver Transection in Patients With Cirrhosis Feng Xia, M.D., Ph.D.,1 Shuguang Wang, M.D., Ph.D., Kuansheng Ma, M.D., Ph.D., Xiaobing Feng, M.D., M.S., Yongjie Su, M.D., and Jiahong Dong, M.D., Ph.D. Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University, Chongqing, China Submitted for publication July 2, 2007
Background. In patients with cirrhosis excessive hemorrhage and the need for blood transfusion are associated with increased postoperative morbidity and mortality as well as a poor long-term outcome. Saline-linked radiofrequency dissecting sealer (TissueLink) is a recent advance in technology that improves hemostasis during difficult liver resections. Preliminary studies have shown that this technique reduces blood loss without inflow occlusion. Patients and methods. A controlled study was performed on 122 consecutive patients with cirrhosis who underwent liver resection for hepatocytotic carcinoma. The outcomes of liver transection with clamp crushing and TissueLink were compared to evaluate which strategy is most beneficial to the patients. Results. Both intraoperative blood loss and blood transfusion requirements were significantly higher in the crushing clamp group than in the TissueLink group (P ⴝ 0.047 and P ⴝ 0.031, respectively). In addition, a significantly higher number of patients required a blood transfusion in the crushing clamp group (P < 0.001). However, the transection time was significantly faster in the crushing clamp group than in the TissueLink group (P < 0.001). The number of patients that required Pringle’s maneuver was markedly higher in the crushing clamp group (P < 0.001). In addition, the hemostasis time was significantly longer in the crushing clamp group (P < 0.001). The serum aspartate aminotransferase levels 3 and 7 days after surgery were significantly higher in the crushing clamp group than in the TissueLink group (P ⴝ 0.035 and P ⴝ 0.003, respectively). Serum total bilirubin levels were markedly increased 3 days after surgery in 1
To whom correspondence and reprint requests should be addressed at Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University, Chongqing, 400038 China. E-mail: [email protected].
0022-4804/08 $34.00 © 2008 Elsevier Inc. All rights reserved.
the crushing clamp group than in the TissueLink group (P ⴝ 0.011). Biliary leakage occurred in a higher number of crushing clamp patients (six) than TissueLink patients (three), although this difference was not significant. The operative morbidity not including biliary leakage was higher in the crushing clamp group than the TissueLink group (nine patients versus five patients, respectively). Conclusion. This study reveals that the TissueLink procedure has beneficial effects during liver transection under cirrhotic conditions in terms of blood loss and reperfusion-related liver injury. However, this procedure requires a significantly longer transection time of the parenchyma. © 2008 Elsevier Inc. All rights reserved. Key Words: saline-linked radiofrequency dissecting sealer; liver transection; cirrhosis; hepatocellular carcinoma. INTRODUCTION
Liver cirrhosis related to hepatitis B is very common in Southeast Asia, especially in China. Approximately 20% of patients with cirrhosis could potentially develop hepatocytotic carcinoma (HCC). The cirrhotic liver usually has a poor hepatic function reserve that can lead to heavy bleeding due to portal hypertension during transection of the hepatic parenchyma. Therefore, patients would benefit greatly from a technique that allows surgery to be performed with limited or no inflow occlusion and minimal blood loss. Liver transection procedures have been improved gradually and progressively in the past two decades [1–3]. Technical innovations have mainly focused on minimizing bleeding during transection since excessive hemorrhage and the need for blood transfusion are associated with increased postoperative morbidity and mortality, as well as a poor long-term outcome. The
110
XIA ET AL.: USING TISSUELINK FOR LIVER TRANSECTION IN CIRRHOTIC PATIENTS
clamp crushing method with Pringle’s maneuver has been used since the early 20th century to prevent bleeding during parenchyma transection. However, inflow occlusion could lead to hepatic ischemia reperfusion injury, especially in patients with cirrhosis [4]. In recent years, the crushing clamp technique has been used clinically with the ultrasonic dissector (Cavitron Ultrasonic Surgical Aspirator, CUSA), water jet dissector, harmonic scalpel, and microwave coagulator. Each device has its own advantages, but to date there is no agreement as to which method is the most beneficial treatment for hepatectomy [5–7]. Hepatectomy and liver transplantation are still considered to be the best choice of treatment for HCC. Hepatectomy remains the main intervention for HCC with cirrhosis, due to a deficient liver donor pool. Thus, many surgeons face the problem of how to perform liver transection under cirrhotic conditions [8 –10]. Saline-linked radiofrequency dissecting sealer (TissueLink medical’s DS3.5) is a recent advance in technology that reportedly improves hemostasis during difficult liver resections and reduces blood loss without inflow occlusion [7]. TissueLink has been used as a routine procedure for liver resection in our Institute since 2004. We have recently carried out a controlled study on hepatectomy in 122 consecutive patients using different devices. The outcomes of liver transection with clamp crushing or TissueLink were compared to evaluate which strategy is most beneficial to cirrhotic patients. PATIENTS AND METHODS A controlled study was performed on 122 consecutive patients with cirrhosis who underwent liver resection between August 2004 and May 2007 for HCC in the Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University (China). The study protocol was approved by the local ethic board of Southwest Hospital. Written informed consent was obtained from all patients before their participation in the study. One team of liver surgeons performed all of the surgeries. The clinical data of each patient were recorded prospectively in a computerized database. All patients followed the same preoperative evaluation protocol including blood biochemistry, percutaneous ultrasonography, spiral computed tomography of the abdomen and computed tomography angiography of the hepatic artery, hepatic vein, and portal vein, chest X-ray, and electrocardiogram. Liver function was assessed by Child’s–Pugh grading, the oral glucose tolerance test, and the indocyanine green clearance test. During the study period, clamp crushing and TissueLink were selected for hepatic resection for HCC. The surgery started with a right subcostal incision or midline incision with a right horizontal extension. Intraoperative ultrasonography was performed routinely to delineate the extent of tumor involvement, to detect tumor nodules in the contralateral lobe and invasion of the tumor into major blood vessels, and to plan and mark the plane of parenchymal transection [11]. Liver hilar dissection was performed and the right or left hepatic artery and portal vein were controlled for anatomical hemihepatectomy. The right lobe of the liver together with the tumor was then completely mobilized from the posterior abdominal wall and rotated anteriorly and to the left to allow separation of the liver from the inferior vena cava [12]. All of the small caval venous branches were individually ligated and divided. The right hepatic
111
vein was then isolated outside the liver, clamped, divided, and sutured before liver transection. Similarly, the falciform ligament and left triangular ligament were also dissected for the mobilization of the left lobe before the liver parenchyma was separated. The low central venous pressure approach was used in all patients. Blood transfusion was launched when hemoglobin levels were lower than 8.0 g/L. An intermittent Pringle’s maneuver consisting of a 5-min break after 15-min occlusion was routinely used with the crushing clamp technique but seldom used during the few cases of marginal resection (mini-volume near the edge). Inflow occlusion was achieved using the tourniquet technique around the portal triad with a 4-mm tape. Liver transection was carried out using parenchyma crushing with a Kelly clamp. All clamped structures including the major intrahepatic bile ducts were ligated or sutured [13, 14]. An alternative procedure for hepatic transection was performed using a saline-linked radiofrequency dissecting sealer. The monopolar device was connected to a compatible electrosurgical generator (Force FX-8C; Valleylab, Tyco Healthcare, Boulder, CO), with an output power set at 70 W. Radiofrequency (480 KHz) energy was focused at the tip and conveyed into the liver tissue by a low flow of saline solution (one drop per second) through a channel inside the device to the tip to induce thermocoagulation of the liver tissue. The continuous flow of saline also cooled the tissue surface at a temperature below 100°C to prevent charring and escar formation. The pointed tip of the cone-shaped dissector allowed dissection of the liver parenchyma after coagulation without the need for clamp crushing. Small vessels (⬍3 mm in diameter) were simply sealed using the dissecting sealer and divided. Larger vessels were ligated and divided. In all patients, hepatic transection was performed without Pringle’s maneuver unless heavy bleeding occurred. A combination of an ultrasonic dissector (CUSA; 23 kHz standard tip, cauter 70 W, flush 4 mL/min, sensitivity 100%) and TissueLink was used for parenchyma transection around the main bile duct for preventing bile duct injury. The CUSA was used predominantly for breaking the parenchyma, sucking out the slush, and presenting the vessel. All patients received the same postoperative care by the same team of surgeons and were nursed in the intensive care unit during the early postoperative course. Parenteral nutritional support was provided for patients with liver cirrhosis. Early enteric nutrition was encouraged once bowel activity returned. All intraoperative and postoperative complications were recorded prospectively. Biliary leakage was diagnosed when the total bilirubin level in the drainage fluid exceeded 85 mol/L 7 days after surgery. Major biliary leakage was diagnosed when the drain could be removed at least 2 weeks after surgery, or when either relaparotomy or percutaneous drainage was required. Hospital death was defined as death during the hospital stay due to the hepatic resection. Statistical analysis was performed using the 2 test or the Fisher exact test to compare discrete variables, and the Mann–Whitney test was used to compare continuous variables. P ⬍ 0.05 was considered to be statistically significant. Statistical analyses were performed with SPSS 10.0 for Windows computer software (SPSS Inc., Chicago, IL).
RESULTS
Of the 122 patients with cirrhosis that underwent hepatic resection for HCC, 61 patients were treated using the crushing clamp technique and 61 patients were treated using the TissueLink method. The clinical and laboratory data were compared between the two groups (Table 1). There were more men in each group. However, there were no significant differences between the two groups. The intraoperative clinical parameters were compared between the two groups (Table 2). The intraop-
112
JOURNAL OF SURGICAL RESEARCH: VOL. 149, NO. 1, SEPTEMBER 2008
TABLE 1
TABLE 3
Clinical and Laboratory Data
Postoperative Outcome Data
Clinical parameters
Crushing clamp
TissueLink
Pa
Clinical parameters
Crushing clamp
No. of patients Male Age (yr) b Platelet count (10 9/L) b Serum AFP (ng/mL) b Serum albumin (g/L) b Serum total bilirubin (mol/L) b AST (IU/L) b Hemoglobin (g/L) b ICG retention at 15 min (%) b Child–Pugh grade A B Tumor size (mm) b Type of resection Minor Major c
61 50 48 (29–77) 164 (32–345) 433 (2.8–23,974) 34 (24–52)
61 47 51 (27–75) 124 (41–310) 326 (7.7–15,523) 36 (26–51)
— 0.654 0.203 0.263 0.099 0.358
246 (34–1569) 104 (12–1124)
112 (58–864) 0.035 32 (15–168) 0.003
132 (18–434)
48 (25–154) 0.011 0.491 2 1
17 (8–54) 54 (14–528) 11.3 (6–17.4)
14 (5–48) 61 (12–496) 10.5 (5.9–16.8)
0.325 0.679 0.372
11.4 (1.8–35.7)
12.1 (4.6–36.2)
0.381 0.678
Serum AST on day 3 (IU/L) Serum AST on day 7 (IU/L) Serum total bilirubin on day 3 (mol/L) Biliary leakage Minor Major Operative morbidity not including biliary leakage Minor Major Hospital stay (days) Hospital deaths
44 17 57 (13–149)
47 14 49 (11–148)
22 39
a
3 3
Pa
TissueLink
0.395 5 4 16 (9–42) 2
4 1 14 (9–32) 0
0.216 —
Crushing clamp group compared with TissueLink group.
0.191 0.271
29 32
AFP ⫽ alpha fetoprotein; AST ⫽ aspartate aminotransferase; ICG ⫽ indocyanine green. a Crushing clamp group compared with TissueLink group. b Value expressed in median with range in parentheses. c Major hepatectomy was defined as ⱖ3 segments.
erative blood loss and blood transfusion requirement were both significantly higher in the crushing clamp group than in the TissueLink group (P ⫽ 0.047 and P ⫽ 0.031, respectively). In addition, a significantly higher number of crushing clamp patients required blood transfusion than TissueLink patients (P ⬍ 0.001). However, the transection time was significantly faster in the crushing clamp group than in the TissueLink group (P ⬍ 0.001). The number of patients that required the Pringle’s maneuver was markedly increased in the crushing clamp group (P ⬍ 0.001). The hemostasis time was significantly longer in the crushing clamp group (P ⬍ 0.001). The postoperative outcome was compared between the two groups (Table 3). The serum aspartate aminotransferase (AST) levels 3 and 7 days after surgery
were significantly higher in the crushing clamp group than in the TissueLink group (P ⫽ 0.035 and P ⫽ 0.003, respectively). However, by day 7, the serum AST levels in the crushing clamp group were similar to those levels observed in the TissueLink group on day 3. Serum total bilirubin levels on day 3 were markedly higher in the crushing clamp group than in the TissueLink group (P ⫽ 0.011). The surgical complication rate was compared between the two groups (Table 3). Biliary leakage occurred in more patients from the crushing clamp group (six patients) than the TissueLink group (three patients), although this difference was not statistically significant. The operative morbidity not including biliary leakage was higher in the crushing clamp group than the TissueLink group (nine patients versus five patients, respectively). Minor complications that occurred in the clamp crushing patients included ascites (two patients), incision infection (two), and ileus (one). Major complications such as postoperative bleeding (two patients), intra-abdominal sepsis (one patient), and total incision dehiscence (one patient) were also observed in the crushing clamp group. The hospital stay appeared to be longer in the crushing clamp
TABLE 2 Intraoperative Outcome Data Clinical parameters
Crushing clamp
TissueLink
Pa
Intraoperative blood loss (mL) b Intraoperative blood transfusion (mL) b No. of patients without transfusion (%) Transection time (min) b No. of patients with Pringle (%) Hemostasis time (min) b
750 (150–6800) 950 (0–6500) 25 (41.0%) 32 (8–102) 53 (86.9%) 25 (8–48)
350 (40–2000) 600 (0–1500) 54 (88.5%) 85 (20–182) 7 (11.5%) 4 (0–12)
0.047 0.031 ⬍0.001 ⬍0.001 ⬍0.001 ⬍0.001
a b
Crushing clamp group compared with TissueLink group. Value expressed in median with range in parentheses.
XIA ET AL.: USING TISSUELINK FOR LIVER TRANSECTION IN CIRRHOTIC PATIENTS
group, although this difference was not significant. Two hospital deaths occurred in the crushing clamp group due to liver failure (one patient) and heavy postoperative bleeding (one patient). DISCUSSION
TissueLink is a new device used clinically for hepatectomy in a few centers worldwide. The benefits of this technique have not been widely confirmed. This study reveals that TissueLink has beneficial effects during liver transection in cirrhotic patients with respect to blood loss and reperfusion-related liver injury. However, this procedure results in a significantly longer transection time of the parenchyma. Liver cirrhosis reduces the ability of the liver to endure anoxemia. The conventional approach for liver transection using a crushing clamp requires the Pringle’s maneuver for reducing intraoperative blood loss. Thus, the development of a new approach for transection without occlusion of liver inflow would benefit from the restoration of postoperative hepatic function [3, 4, 7, 15]. Our study revealed that the benefits of the TissueLink procedure included its ability to decrease the use of the inflow occlusion, which reduces the intraoperative blood loss and ischemia-reperfusion injury. Three previous studies have also assessed the benefits of a saline-linked radiofrequency dissecting sealer in hepatic resection and in two cases reduced blood loss was reported. Sakamoto et al. reported that the use of a Floating Ball (Tissue Link Medical) device significantly reduced the amount of blood loss during liver transection compared with that observed with the crushing clamp method (median 200 mL versus 480 mL) [16]. The Floating Ball has the same mechanism as the TissueLink (DS 3.5), although its tip shape is different. Sturgeon et al. reported a mean blood loss as low as 165 mL during liver parenchymal division with use of the Floating Ball [17]. The reason a third randomized clinical trial did not reveal beneficial effects in terms of blood loss might be due to the differences in patients included in the study. Of 80 patients that were divided equally into dissecting sealer and crushing clamp groups, 9 patients in the dissecting sealer group had cirrhosis compared to 12 in the crushing clamp group. Most of the patients (21/80) did not suffer with cirrhosis, a condition that might cause more blood loss due to portal hypertension [18]. Another advantage of the TissueLink method observed in this study was that its sealing effect decreased biliary leakage and other morbidity as described previously. The TissueLink procedure often resulted in a prolonged transection time, indicating that this procedure requires more patience and skill by the operator. For example, heavy bleeding might occur if the parenchyma is dissected before the mini vessels have coagulated properly. Previous studies have also reported
113
that use of TissueLink increases the operating time and causes a greater increase in the serum AST level than the clamp crushing method for hepatic resection [16 –19]. In this study, the serum AST level increased significantly postoperatively possibly due to scalding of the liver parenchyma. However, its injury was markedly lower than that associated with ischemiareperfusion injury, and the AST level recovered very rapidly compared to that observed in the crushing clamp group. In conclusion, TissueLink is the preferred procedure for liver transection in patients with cirrhosis, because its use leads to improved surgical outcomes. Further studies, ideally in a prospective randomized clinical trial, are required to document the advantages of TissueLink as a routine technique for all hepatic resections including those under cirrhotic conditions.
REFERENCES 1.
Shi M, Guo RP, Lin XJ, et al. Partial hepatectomy with wide versus narrow resection margin for solitary hepatocellular carcinoma: A prospective randomized trial. Ann Surg 2007;245:36.
2.
Fortner JG, Kim DK, Maclean BJ, et al. Major hepatic resection for neoplasia: Personal experience in 108 patients. Ann Surg 1978;188:363.
3.
Fan ST, Lo CM, Liu CL, et al. Hepatectomy for hepatocellular carcinoma: Toward zero hospital deaths. Ann Surg 1999;229: 322.
4.
Tanaka S, Noguchi N, Ochiai T, et al. Outcomes and recurrence of initially resectable hepatocellular carcinoma meeting milan criteria: Rationale for partial hepatectomy as first strategy. J Am Coll Surg 2007;204:1.
5.
Marrero JA, Pelletier S. Hepatocellular carcinoma. Clin Liver Dis 2006;10:339.
6.
Benzoni E, Lorenzin D, Baccarani U, et al. Resective surgery for liver tumor: A multivariate analysis of causes and risk factors linked to postoperative complications. Hepatobiliary Pancreat Dis Int 2006;5:526.
7.
Poon RT, Fan ST, Wong J. Liver resection using a saline-linked radiofrequency dissecting sealer for transection of the liver. J Am Coll Surg 2005;200:308.
8.
Fan ST, Lai EC, Lo CM, et al. Hospital mortality of major hepatectomy for hepatocellular carcinoma associated with cirrhosis. Arch Surg 1995;130:198.
9.
Makuuchi M, Takayama T, Kubota K, et al. Hepatic resection for hepatocellular carcinoma: Japanese experience. Hepatogastroenterology 1998;45:1267.
10.
Takenaka K, Kawahara N, Yamamoto K, et al. Results of 280 liver resections for hepatocellular carcinoma. Arch Surg 1996; 131:71.
11.
Couinaud C. Le Foie. Etudes Anatomiques et Chirurgicales. Paris: Masson, 1957.
12.
Chen XP, Qiu FZ, Wu ZD, et al. Hepatectomy for huge hepatocellular carcinoma in 634 cases. World J Gastroenterol 2006; 12:4652.
13.
Xia F, Poon RT, Fan ST, et al. Thoracoabdominal approach for right-sided hepatic resection for hepatocellular carcinoma. J Am Coll Surg 2003;196:418.
114 14.
JOURNAL OF SURGICAL RESEARCH: VOL. 149, NO. 1, SEPTEMBER 2008
John AR, Khan S, Mirza DF, et al. Multivariate and univariate analysis of prognostic factors following resection in HCC: The Birmingham experience. Dig Surg 2006;23:103. 15. Le Treut YP, Hardwigsen J, Ananian P, et al. Resection of hepatocellular carcinoma with tumor thrombus in the major vasculature. A European case-control series. J Gastrointest Surg 2006;10:855. 16. Sakamoto Y, Yamamoto J, Kokudo N, et al. Bloodless liver resection using the monopolar Floating Ball plus LigaSure diathermy: preliminary results of 16 liver resections. World J Surg 2004;28:166.
17.
Sturgeon C, Helton WS, Lamba A, et al. Early experience employing a linear hepatic parenchyma coagulation device. J Hepatobiliary Pancreat Surg 2003;10:81. 18. Arita J, Hasegawa K, Kokudo N, et al. Randomized clinical trial of the effect of a saline-linked radiofrequency coagulator on blood loss during hepatic resection. Br J Surg 2005;92: 954. 19. Geller DA, Tsung A, Maheshwari V, et al. Hepatic resection in 170 patients using saline-cooled radiofrequency coagulation. HPB 2005;7:208.