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LigaSure versus conventional dissection technique in pancreatoduodenectomy: a pilot study
The American Journal of Surgery (2011) 201, 166 –170
Clinical Science
LigaSure versus conventional dissection technique in pancreatoduodenectomy: a pilot study Tobias Gehrig, M.D., Beat P. Müller-Stich, M.D., Hannes Kenngott, M.D., Lars Fischer, M.D., Arianeb Mehrabi, M.D., Markus W. Büchler, M.D.*, Carsten N. Gutt, M.D. Department of General, Abdominal and Transplant Surgery, Ruprecht-Karls-University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany KEYWORDS: LigaSure; Conventional dissection techniques; Pancreatoduodenectomy
Abstract BACKGROUND: Pancreatic surgery requires extensive preparation and tissue dissection. Therefore, LigaSure (Valleylab, Boulder, CO) provides an alternative to conventional dissection techniques. The aim of the present study was to describe the feasibility, safety, and cost efficiency of LigaSure in pancreatoduodenectomy. METHODS: Seven patients underwent surgery with the Ligasure and 7 patients underwent surgery with conventional dissection techniques. The patients were investigated for surgical time, intraoperative blood loss, complications, mortality, duration of hospital stay, and surgery-related costs. RESULTS: Surgical time was 207 minutes in the LigaSure group and 255 minutes in the conventional group (P ⫽ .020). Intraoperative blood loss was 271 and 771 mL, respectively (P ⫽ .010). Other perioperative outcomes were comparable. The respective surgery-related costs averaged €4,125 and €4,931 (P ⫽ .023). CONCLUSIONS: The use of LigaSure in pancreatoduodenectomy seems to be feasible and safe. In addition, it might lead to a reduction in the surgery-related costs. © 2011 Elsevier Inc. All rights reserved.
Both the standard technique for operable pancreatic head cancer, the classic Whipple, and the pylorus-preserving Whipple (PPW) require extensive dissection.1 In general, a conventional technique is performed with scissors for dissection. Ligatures, clips, and sutures are used for hemostasis, and small-bowel transection usually is performed with staplers. As a result, a long surgical time and high material consumption lead to considerable overall costs. High-frequency, feedback-controlled, electrothermal, bipolar vessel sealant technology, well-known as the Liga* Corresponding author. Tel.: ⫹(49) 6221-56-6500; fax: ⫹(49) 622156-6992. E-mail address: [email protected] Manuscript received November 10, 2009; revised manuscript February 8, 2010
0002-9610/$ - see front matter © 2011 Elsevier Inc. All rights reserved. doi:10.1016/j.amjsurg.2010.02.023
Sure Vessel Sealing System (LVSS; Valleylab, Boulder, CO), provides an alternative, whereby virtually the entire procedure is performed with one device, including dissection, hemostasis, and bowel transection. This device applies a defined rate of bipolar energy and pressure to fuse the collagen and elastin within the tissue.2 An impedancebased, feedback-controlled generator allows for precise delivery of energy.3 Several investigators have described the use of this technology as a safe method for different surgical interventions, with a trend toward decreased blood loss and less need for intraoperative transfusion of blood erythrocyte concentrates.4 –7 Other recent studies have shown a reduction in the surgical time.5,7–9 The aim of this pilot casecontrol study was to present our initial experience with LVSS for the whole preparation procedure, including transection of the small bowel during PPW, and to show its
T. Gehrig et al.
LVSS vs conventional dissection technique
Figure 1 Transection of the proximal duodenum with LVSS (to preserve the pylorus).
feasibility and safety. An additional aim was to obtain estimates for the sample size calculation of a future randomized controlled trial. To that effect, operating time, intraoperative blood loss, complications, and hospital stay, as well as mortality were compared. Furthermore, the costs incurred for surgical time and material consumption in both techniques were compared.
Material and Methods Patient selection Fourteen consecutive patients who had undergone a PPW procedure for a pancreatic head tumor in our department in January 2008 were included in the present pilot case-control study. In 7 patients LVSS using the LigaSure Atlas device (Valleylab, Boulder, CO) was used for virtually the whole dissection (LVSS group) and 7 patients underwent surgery with a conventional dissection technique (conventional group). All patients underwent surgery by surgeons highly experienced in pancreatic surgery (⬎100 PPW procedures performed). Criteria for study inclusion were suspicion of a technically resectable pancreatic head cancer without any vascular infiltration, age 18 years and older, and availability of written informed consent. Patients who had undergone extended resections and vascular surgery or previous upper abdominal surgery were excluded.
167 hepatic duct. Next, the portal vein is exposed. A tunnel beneath the neck of the pancreas in front of the inferior mesenteric vein is made to be sure that the vein is not infiltrated. After division of the right gastric artery, gastroduodenal artery, and gastroepiploic vessels, the duodenum distal to the pylorus is divided (Fig. 1). The pancreas is transected in front of the portal vein using a scalpel, not with the LigaSure Atlas device. Then, dissection of the distal duodenum proximal to the ligament of Treitz is performed. This is followed by the reconstruction phase with preparation and resection of the proximal 10- to 15-cm section of the jejunum at a point that will provide sufficient mobility of the jejunum to reach the right upper quadrant after it is brought through the transverse mesocolon for the biliary and pancreatic anastomosis. Pancreatojejunostomy is performed with 2 layers, end-to-side, after mobilization of the pancreatic stump (Fig. 2). The end-to-side hepatojejunostomy is made with a single layer and is placed about 10 to 15 cm distal of the pancreatojejunostomy. Finally, an endto-side duodenojejunostomy with 2 layers is performed about 50 cm distal to the pancreatojejunostomy in an antecolic position. In the LVSS group, preparation, dissection, and hemostasis of vessels with a diameter of up to 7 mm as well as bowel transection were performed with the LigaSure Atlas device. For safety reasons, the transected bowel was overstitched and larger vessels were ligated in the LVSS group. In the conventional group, scissors, ligatures, clips, and sutures were used for preparation and hemostasis. Transection of the small bowel was performed with staplers.
Perioperative assessment A set of perioperative data were analyzed including surgical time, intraoperative blood loss, complications, mortality, postoperative hospital stay, and costs resulting from material consumption and surgical time. Surgical time was recorded from the time of incision to skin closure. Intraoperative blood loss and intraoperative complications were
Surgical technique The highly standardized PPW surgical technique in our surgical department consists of the following surgical steps:10,11 after mobilization of the hepatic flexure of the colon, the duodenum and head of the pancreas are separated from the retroperitoneal bed (Kocher maneuver) by use of electrocautery. The gallbladder is removed and the bile duct is divided above the cystic duct entry across the common
Figure 2 Mobilization of the pancreatic stump with LVSS. The pancreas is transected using a scalpel.
168 documented at the end of the surgery. Mortality, postoperative complications, and length of hospital stay were registered on the day of discharge. Costs included expenditure for personnel and use of the operating room as well as for material consumption. The mean costs for 1 hour of surgical time without material consumption in our institution were €1,065.2 for PPW. Material costs were calculated from the number of ligatures, sutures, clips, universal stapling devices, cartridges, and the LigaSure Atlas device used. Other direct or indirect costs were not included in the calculation because they were assumed to be equal in both groups.
Statistical analysis All calculations were conducted using SPSS version 16.0 (SPSS, Chicago, IL). No power calculation has been performed so far. The present pilot study was conducted with the aim of generating estimates for the sample size calculation of a future randomized controlled trial, in which surgical time and costs are to be the intended primary end points. Perioperative outcome will represent a secondary end point. Values are presented as mean plus or minus standard deviation and range except for the duration of hospital stay, which is presented as median plus range, because of the inequality of distribution. Continuous variables were compared using the Student t test or the Wilcoxon test, depending on data distribution. Categoric data were compared using the Fisher exact test. A two-sided P value of less than .05 was considered statistically significant.
Results Patients were well matched for sex, age, body mass index, and surgical risk. There were a total of 14 patients (5 men [36%] and 9 women [64%], age range, 55– 82 y). There were 4 women and 3 men in the LVSS group and 5 women and 2 men in the conventional group. The average age was 69.0 years in the LVSS group and 70.6 years in the conventional group. The average body mass index was 25.5 kg/m2 in the LVSS group and 25.2 kg/m2 in the conventional group. The American Society of Anesthesiologists (ASA) classification was the same. Five patients were ASA class II and 2 patients were ASA class III in both groups. As shown in Table 1, patients also were well matched for tumor characteristics. The intraoperative and postoperative outcomes are summarized in Table 2. Surgical time was found to be shorter and blood loss to be less in the LVSS group compared with the conventional group. Accordingly, only 1 patient in the conventional group needed transfusion of erythrocyte concentrates owing to intraoperative blood loss. There were no further intraoperative complications. The postoperative course was similar in both groups. In the conventional group 1 patient had insufficiency of the biliodigestive anastomosis necessitating interventional percuta-
The American Journal of Surgery, Vol 201, No 2, February 2011 Table 1
Tumor characteristics
Type Adenocarcinoma Serous microcystic adenoma IPMN Acinus cell cyst adenoma Localization Pancreatic head Pancreatic corpus Duodenum Bile duct Papilla Stage TxN0M0 T3N0M0 T3N1M0 T4N1M0
LVSS group (n ⫽ 7)
Conventional group (n ⫽ 7)
6
4
0 0
2 1
1
0
4 0 1 1 1
6 1 0 0 0
.559
1 2 3 0
0 1 2 1
1.000
P value .315
IPMN ⫽ intraductal papillary mucinous neoplasm.
neous transhepatic biliary drainage. This patient could be treated conservatively and no reoperation was needed. In addition, there was 1 postoperative pulmonary embolism in the conventional group and 1 case of pneumonia in the LVSS group, both of which could be treated conservatively. There were no further postoperative complications. The mortality was zero in both groups and the median hospital stay did not differ. However, for the patient with insufficiency of the biliodigestive anastomosis the stay was prolonged to 76 days. The cost analysis is displayed in Table 3. The surgeryrelated costs, consisting of time- and material-related costs, averaged 4,124.5 ⫾ 488 € in the LVSS group and 4,931 ⫾ 644.9 € (P ⫽ .023) in the conventional group. Hence, a mean intraoperative cost savings of €806.5 was obtained, which was mainly owing to the reduction in surgical time. The material consumption was not different but with a trend in favor of the conventional group.
Comments LVSS dissection technique seems to be a feasible and safe alternative to conventional dissection technique using scissors, ligatures, clips, and sutures for PPW. In the present pilot study we found a reduction in surgical time and intraoperative blood loss in the LVSS group, however, the perioperative course was comparable in both groups. Above all, to date we have note had any pancreatic fistula, intraabdominal abscess, wound infection, or delayed gastric emptying, which have been described as relevant problems of pancreatoduodenectomy.12,13 These findings are in ac-
T. Gehrig et al. Table 2
LVSS vs conventional dissection technique
169
Perioperative course
Surgical time, min* Intraoperative blood loss, mL* Complications, n (%) Hospital stay, d†
LVSS group (n ⫽ 7)
Conventional group (n ⫽ 7)
P value
207.1 ⫾ 27.7 (180–250) 271.4 ⫾ 107.5 (100–400) 1 (12) 15 (12–17)
254.7 ⫾ 35.8 (215–328) 771.4 ⫾ 363.8 (500–1500) 2 (28) 14 (19–76)
.881 .010 1.000 .406
*Values shown are the mean ⫾ standard deviation and range. †Value shown is the median (range).
cordance with other published data showing that electrothermal bipolar vessel sealant technology seems to be a safe alternative to the conventional use of clamps, ligatures, sutures, and clips for both laparoscopic and open surgery.4,9,14 –17 Slomovitz et al4 performed surgery on 12 patients with pelvic exenteration using LVSS. They found no coagulator-related complications and none of the patients had any complications necessitating reoperation. Likewise, Kössi et al17 performed a total of 112 laparoscopic splenectomies. The intraoperative and postoperative complications were similar in the LVSS group compared with the conventional group using monopolar coagulation and endostapler for preparation and hilar dissection.16 Compared with open radical prostatectomies and radical cystectomies with conventional dissection, Daskalopoulos et al15 found neither serious intraoperative nor postoperative complications related to the use of LVSS in a study of 58 patients. The reduced intraoperative blood loss in the LVSS group of our study relates favorably to the findings of other investigators who found a perioperative blood loss reduction of 143 mL in esophageal cancer resection,5 115 mL in laparoscopic splenectomy,16 116 mL in open radical prostatectomies, and 107 mL in radical cystectomies15 when using LVSS compared with conventional dissection technique. To date, the LVSS dissection technique has been described for certain steps of pancreatoduodenectomy, namely limited use for dissection of the mesenteric blood supply.14 Up to now, there has been only one single case reported by Belli et al,18 in which LVSS was used for the entire dissection procedure except for bowel transection. We applied the same technique, however, with the difference that LVSS also was used for bowel transection. There are few published reports of experiences using LVSS for bowel tran-
Table 3
section and the findings are inconsistent. Salameh et al19 compared 6 pigs with bowel transection performed with endoscopic linear stapling/cutting device with 6 pigs with bowel transection double-sealed with LVSS. They found that division of the small bowel with LVSS was unsafe and inefficient. Burst pressure for stapled segments was significantly higher than for segments cut with LVSS. In contrast, Smulders et al20 stated that creating an intestinal anastomosis using LVSS was feasible and safe. They performed 8 anastomoses with LVSS in 4 pigs and found macroscopic and microscopic intact anastomoses after 1 week. Because of the limited experiences published to date and the inconsistency of findings, we decided to overstitch the transected bowel in our LVSS group. By doing so, we were able to avoid any leaks. The most important benefit of LVSS might be related to its cost-cutting potential as a result of reduced surgical time. We had a mean reduction of 48 minutes, resulting in a mean cost savings of €806.5 in the LVSS group. The costs for material consumption were similar in the LVSS group, with a trend in favor of the conventional dissection technique. Considering that in the present study the LigaSure Atlas device was used, it is possible that in the future the Ligasure Impact with a faster technology will lead to even further reductions in surgical time and costs. Our experience relates favorably to other published data. Eroglu et al5 described a significant mean reduction in surgical time of 47 minutes in esophageal cancer resection compared with conventional surgery in a study of 60 patients. Saint Marc et al21 showed the same effect with a significant decrease in surgical time for 200 patients who had undergone total thyroidectomy. However, the 7-minute time savings in this uncomplicated surgery was too small to offset the higher material costs in the LVSS group. It seems that the more complex and time-
Costs in Euros (€)
Costs related to surgical time Costs related to material consumption Total variable costs related to the surgery*
LVSS group (n ⫽ 7)
Conventional group (n ⫽ 7)
P value
3,677.3 ⫾ 491.2 447.2 ⫾ 58.9 4,124.5 ⫾ 488
4,521.8 ⫾ 636.2 409.2 ⫾ 30.3 4,931 ⫾ 644.9
.020 .160 .023
Values shown are the mean ⫾ standard deviation. *Includes the expenses for personnel and the use of the operating room as well as the material consumption. Other direct or indirect costs were not included in the calculation because they were assumed to be equal in both groups.
170 consuming a procedure, the greater is the cost-saving effect of dissection with LVSS. Pancreatoduodenectomy, as in our study, seems to be a perfect example confirming that assumption. However, to draw a final conclusion in this regard, well-designed randomized controlled studies with adequate sample sizes are needed. Based on power analysis, 46 patients were needed in each group to detect a mean surgical time difference of 47 minutes between the 2 groups, with 80% power and a significance level of .05. In conclusion, the present pilot case-control study indicates that LVSS can be used safely and efficiently for virtually the entire PPW dissection technique. In addition, LVSS might lead to a reduction in the surgery-related costs mainly owing to the shorter surgical time needed in extended procedures such as pancreatoduodenectomy. However, to confirm these findings well-designed randomized controlled trials are needed in the future. The estimates obtained in the present study may be helpful in planning such trials.
Acknowledgments The authors have no financial or other related disclosures to declare. No external funds were used to perform the evaluation, and all of the tested technology was purchased separately to complete the study. In addition, the authors had full control of the design of the study, methods used, outcome measurements, analysis of data, and production of the written report.
References 1. Diener M, Heukaeufer C, Schwarzer G, et al. Pancreaticoduodenectomy (classic Whipple) versus pylorus-preserving pancreaticoduodenectomy (ppp Whipple) for surgical treatment of periampullary and pancreatic carcinoma. Cochrane Library; 2008;2:CD006053. 2. Heniford BT, Sing R, Matthews B, et al. Initial research and clinical results with an electrothermal bipolar vessel sealer. Surg Endosc 2001; 15:799 – 801. 3. Kennedy JS, Stranahan PL, Taylor KD, et al. High-burst-strength, feedback-controlled bipolar vessel sealing. Surg Endosc 1998; 12:876 – 8.
The American Journal of Surgery, Vol 201, No 2, February 2011 4. Slomovitz BM, Ramirez PT, Frumovitz M, et al. Electrothermal bipolar coagulation for pelvic exenterations. Gynecol Oncol 2006;102: 534 – 6. 5. Eroglu A, Turkyilmaz A, Aydin Y, et al. The use of the Ligasure vessel sealing system in esophageal cancer surgery. Ann Thorac Surg 2007; 84:2076 – 80. 6. Cheang T, Hanna SS, Wright FC, et al. Use of a collagen-sealing device in hepatic resection: a comparative analysis to standard resection technique. HPB (Oxford) 2006;8:194 –9. 7. Sengupta S, Webb DR. Use of a computer-controlled bipolar diathermy system in radical prostatectomies and other open urological surgery. Aust N Z J Surg 2001;71:538 – 40. 8. Youssef T, Mahdy T, Farid M, et al. Thyroid surgery: use of the Ligasure vessel sealing system versus conventional knot tying. Int J Surg 2008;6:323–7. 9. Muzi MG, Milito G, Nigro C, et al. Randomized clinical trial of Ligasure and conventional diathermy haemorrhoidectomy. Br J Surg 2007;94:937– 42. 10. Weitz J, Koch M, Kleef J, et al. Kausch-Whipple pancreaticoduodenectomy. Technique and results. Chirurg 2004;75:1113–9. 11. Warshaw AL, Thayer SP. Pancreaticoduodenectomy: “how I do it.” J Gastrointest Surg 2004;8:733– 41. 12. Welsch T, Büchler MW, Schmidt J. Surgery for pancreatic cancer. Z Gastroenterol 2008;46:1393– 403. 13. Nikfarjam M, Sehmbey M, Kimchi ET, et al. Additional organ resection combined with pancreaticoduodenectomy does not increase postoperative morbidity and mortality. J Gastrointest Surg 2009;13: 915–21. 14. Howard TJ, Mimms S. Use of a new sealing device to simplify jejunal resection during pancreaticoduodenectomy. Am J Surg 2005; 190:504 – 6. 15. Daskalopoulos G, Karyotis I, Heretis I, et al. Electrothermal bipolar coagulation for radical prostatectomies and cystectomies: a preliminary case-controlled study. Int Urol Nephrol 2004;36:181–5. 16. Romano F, Gelmini R, Caprotti R, et al. Laparoscopic splenectomy: Ligasure versus EndoGIA: a comparative study. J Laparoendosc Adv Surg Tech A 2007;17:763–7. 17. Kössi J, Luostarinen M, Kontula I, et al. Laparoscopic sigmoid and rectal resection using an electrothermal bipolar vessel sealing device. J Laparoendosc Adv Surg Tech A 2007;17:719 –22. 18. Belli G, Fantini C, Ciciliano F, et al. Pancreaticoduodenectomy in portal hypertension: use of the Ligasure. J Hepatobiliary Pancreat Surg 2003;10:215–7. 19. Salameh JR, Schwartz JH, Hildebrandt DA. Can Ligasure seal and divide the small bowel? Am J Surg 2006;191:791–3. 20. Smulders JF, de Hingh IHJT, Stavast J, et al. Exploring new technologies to facilitate laparoscopic surgery: creating intestinal anastomoses without sutures or staples, using a radio-frequency-energy-driven bipolar fusion device. Surg Endosc 2006;21:2105–9. 21. Saint Marc O, Cogliandolo A, Piquard A, et al. Ligasure vs. clampand-tie technique to achieve hemostasis in total thyroidectomy for benign multinodular goiter. Arch Surg 2007;142:150 – 6.
Clinical Science
LigaSure versus conventional dissection technique in pancreatoduodenectomy: a pilot study Tobias Gehrig, M.D., Beat P. Müller-Stich, M.D., Hannes Kenngott, M.D., Lars Fischer, M.D., Arianeb Mehrabi, M.D., Markus W. Büchler, M.D.*, Carsten N. Gutt, M.D. Department of General, Abdominal and Transplant Surgery, Ruprecht-Karls-University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany KEYWORDS: LigaSure; Conventional dissection techniques; Pancreatoduodenectomy
Abstract BACKGROUND: Pancreatic surgery requires extensive preparation and tissue dissection. Therefore, LigaSure (Valleylab, Boulder, CO) provides an alternative to conventional dissection techniques. The aim of the present study was to describe the feasibility, safety, and cost efficiency of LigaSure in pancreatoduodenectomy. METHODS: Seven patients underwent surgery with the Ligasure and 7 patients underwent surgery with conventional dissection techniques. The patients were investigated for surgical time, intraoperative blood loss, complications, mortality, duration of hospital stay, and surgery-related costs. RESULTS: Surgical time was 207 minutes in the LigaSure group and 255 minutes in the conventional group (P ⫽ .020). Intraoperative blood loss was 271 and 771 mL, respectively (P ⫽ .010). Other perioperative outcomes were comparable. The respective surgery-related costs averaged €4,125 and €4,931 (P ⫽ .023). CONCLUSIONS: The use of LigaSure in pancreatoduodenectomy seems to be feasible and safe. In addition, it might lead to a reduction in the surgery-related costs. © 2011 Elsevier Inc. All rights reserved.
Both the standard technique for operable pancreatic head cancer, the classic Whipple, and the pylorus-preserving Whipple (PPW) require extensive dissection.1 In general, a conventional technique is performed with scissors for dissection. Ligatures, clips, and sutures are used for hemostasis, and small-bowel transection usually is performed with staplers. As a result, a long surgical time and high material consumption lead to considerable overall costs. High-frequency, feedback-controlled, electrothermal, bipolar vessel sealant technology, well-known as the Liga* Corresponding author. Tel.: ⫹(49) 6221-56-6500; fax: ⫹(49) 622156-6992. E-mail address: [email protected] Manuscript received November 10, 2009; revised manuscript February 8, 2010
0002-9610/$ - see front matter © 2011 Elsevier Inc. All rights reserved. doi:10.1016/j.amjsurg.2010.02.023
Sure Vessel Sealing System (LVSS; Valleylab, Boulder, CO), provides an alternative, whereby virtually the entire procedure is performed with one device, including dissection, hemostasis, and bowel transection. This device applies a defined rate of bipolar energy and pressure to fuse the collagen and elastin within the tissue.2 An impedancebased, feedback-controlled generator allows for precise delivery of energy.3 Several investigators have described the use of this technology as a safe method for different surgical interventions, with a trend toward decreased blood loss and less need for intraoperative transfusion of blood erythrocyte concentrates.4 –7 Other recent studies have shown a reduction in the surgical time.5,7–9 The aim of this pilot casecontrol study was to present our initial experience with LVSS for the whole preparation procedure, including transection of the small bowel during PPW, and to show its
T. Gehrig et al.
LVSS vs conventional dissection technique
Figure 1 Transection of the proximal duodenum with LVSS (to preserve the pylorus).
feasibility and safety. An additional aim was to obtain estimates for the sample size calculation of a future randomized controlled trial. To that effect, operating time, intraoperative blood loss, complications, and hospital stay, as well as mortality were compared. Furthermore, the costs incurred for surgical time and material consumption in both techniques were compared.
Material and Methods Patient selection Fourteen consecutive patients who had undergone a PPW procedure for a pancreatic head tumor in our department in January 2008 were included in the present pilot case-control study. In 7 patients LVSS using the LigaSure Atlas device (Valleylab, Boulder, CO) was used for virtually the whole dissection (LVSS group) and 7 patients underwent surgery with a conventional dissection technique (conventional group). All patients underwent surgery by surgeons highly experienced in pancreatic surgery (⬎100 PPW procedures performed). Criteria for study inclusion were suspicion of a technically resectable pancreatic head cancer without any vascular infiltration, age 18 years and older, and availability of written informed consent. Patients who had undergone extended resections and vascular surgery or previous upper abdominal surgery were excluded.
167 hepatic duct. Next, the portal vein is exposed. A tunnel beneath the neck of the pancreas in front of the inferior mesenteric vein is made to be sure that the vein is not infiltrated. After division of the right gastric artery, gastroduodenal artery, and gastroepiploic vessels, the duodenum distal to the pylorus is divided (Fig. 1). The pancreas is transected in front of the portal vein using a scalpel, not with the LigaSure Atlas device. Then, dissection of the distal duodenum proximal to the ligament of Treitz is performed. This is followed by the reconstruction phase with preparation and resection of the proximal 10- to 15-cm section of the jejunum at a point that will provide sufficient mobility of the jejunum to reach the right upper quadrant after it is brought through the transverse mesocolon for the biliary and pancreatic anastomosis. Pancreatojejunostomy is performed with 2 layers, end-to-side, after mobilization of the pancreatic stump (Fig. 2). The end-to-side hepatojejunostomy is made with a single layer and is placed about 10 to 15 cm distal of the pancreatojejunostomy. Finally, an endto-side duodenojejunostomy with 2 layers is performed about 50 cm distal to the pancreatojejunostomy in an antecolic position. In the LVSS group, preparation, dissection, and hemostasis of vessels with a diameter of up to 7 mm as well as bowel transection were performed with the LigaSure Atlas device. For safety reasons, the transected bowel was overstitched and larger vessels were ligated in the LVSS group. In the conventional group, scissors, ligatures, clips, and sutures were used for preparation and hemostasis. Transection of the small bowel was performed with staplers.
Perioperative assessment A set of perioperative data were analyzed including surgical time, intraoperative blood loss, complications, mortality, postoperative hospital stay, and costs resulting from material consumption and surgical time. Surgical time was recorded from the time of incision to skin closure. Intraoperative blood loss and intraoperative complications were
Surgical technique The highly standardized PPW surgical technique in our surgical department consists of the following surgical steps:10,11 after mobilization of the hepatic flexure of the colon, the duodenum and head of the pancreas are separated from the retroperitoneal bed (Kocher maneuver) by use of electrocautery. The gallbladder is removed and the bile duct is divided above the cystic duct entry across the common
Figure 2 Mobilization of the pancreatic stump with LVSS. The pancreas is transected using a scalpel.
168 documented at the end of the surgery. Mortality, postoperative complications, and length of hospital stay were registered on the day of discharge. Costs included expenditure for personnel and use of the operating room as well as for material consumption. The mean costs for 1 hour of surgical time without material consumption in our institution were €1,065.2 for PPW. Material costs were calculated from the number of ligatures, sutures, clips, universal stapling devices, cartridges, and the LigaSure Atlas device used. Other direct or indirect costs were not included in the calculation because they were assumed to be equal in both groups.
Statistical analysis All calculations were conducted using SPSS version 16.0 (SPSS, Chicago, IL). No power calculation has been performed so far. The present pilot study was conducted with the aim of generating estimates for the sample size calculation of a future randomized controlled trial, in which surgical time and costs are to be the intended primary end points. Perioperative outcome will represent a secondary end point. Values are presented as mean plus or minus standard deviation and range except for the duration of hospital stay, which is presented as median plus range, because of the inequality of distribution. Continuous variables were compared using the Student t test or the Wilcoxon test, depending on data distribution. Categoric data were compared using the Fisher exact test. A two-sided P value of less than .05 was considered statistically significant.
Results Patients were well matched for sex, age, body mass index, and surgical risk. There were a total of 14 patients (5 men [36%] and 9 women [64%], age range, 55– 82 y). There were 4 women and 3 men in the LVSS group and 5 women and 2 men in the conventional group. The average age was 69.0 years in the LVSS group and 70.6 years in the conventional group. The average body mass index was 25.5 kg/m2 in the LVSS group and 25.2 kg/m2 in the conventional group. The American Society of Anesthesiologists (ASA) classification was the same. Five patients were ASA class II and 2 patients were ASA class III in both groups. As shown in Table 1, patients also were well matched for tumor characteristics. The intraoperative and postoperative outcomes are summarized in Table 2. Surgical time was found to be shorter and blood loss to be less in the LVSS group compared with the conventional group. Accordingly, only 1 patient in the conventional group needed transfusion of erythrocyte concentrates owing to intraoperative blood loss. There were no further intraoperative complications. The postoperative course was similar in both groups. In the conventional group 1 patient had insufficiency of the biliodigestive anastomosis necessitating interventional percuta-
The American Journal of Surgery, Vol 201, No 2, February 2011 Table 1
Tumor characteristics
Type Adenocarcinoma Serous microcystic adenoma IPMN Acinus cell cyst adenoma Localization Pancreatic head Pancreatic corpus Duodenum Bile duct Papilla Stage TxN0M0 T3N0M0 T3N1M0 T4N1M0
LVSS group (n ⫽ 7)
Conventional group (n ⫽ 7)
6
4
0 0
2 1
1
0
4 0 1 1 1
6 1 0 0 0
.559
1 2 3 0
0 1 2 1
1.000
P value .315
IPMN ⫽ intraductal papillary mucinous neoplasm.
neous transhepatic biliary drainage. This patient could be treated conservatively and no reoperation was needed. In addition, there was 1 postoperative pulmonary embolism in the conventional group and 1 case of pneumonia in the LVSS group, both of which could be treated conservatively. There were no further postoperative complications. The mortality was zero in both groups and the median hospital stay did not differ. However, for the patient with insufficiency of the biliodigestive anastomosis the stay was prolonged to 76 days. The cost analysis is displayed in Table 3. The surgeryrelated costs, consisting of time- and material-related costs, averaged 4,124.5 ⫾ 488 € in the LVSS group and 4,931 ⫾ 644.9 € (P ⫽ .023) in the conventional group. Hence, a mean intraoperative cost savings of €806.5 was obtained, which was mainly owing to the reduction in surgical time. The material consumption was not different but with a trend in favor of the conventional group.
Comments LVSS dissection technique seems to be a feasible and safe alternative to conventional dissection technique using scissors, ligatures, clips, and sutures for PPW. In the present pilot study we found a reduction in surgical time and intraoperative blood loss in the LVSS group, however, the perioperative course was comparable in both groups. Above all, to date we have note had any pancreatic fistula, intraabdominal abscess, wound infection, or delayed gastric emptying, which have been described as relevant problems of pancreatoduodenectomy.12,13 These findings are in ac-
T. Gehrig et al. Table 2
LVSS vs conventional dissection technique
169
Perioperative course
Surgical time, min* Intraoperative blood loss, mL* Complications, n (%) Hospital stay, d†
LVSS group (n ⫽ 7)
Conventional group (n ⫽ 7)
P value
207.1 ⫾ 27.7 (180–250) 271.4 ⫾ 107.5 (100–400) 1 (12) 15 (12–17)
254.7 ⫾ 35.8 (215–328) 771.4 ⫾ 363.8 (500–1500) 2 (28) 14 (19–76)
.881 .010 1.000 .406
*Values shown are the mean ⫾ standard deviation and range. †Value shown is the median (range).
cordance with other published data showing that electrothermal bipolar vessel sealant technology seems to be a safe alternative to the conventional use of clamps, ligatures, sutures, and clips for both laparoscopic and open surgery.4,9,14 –17 Slomovitz et al4 performed surgery on 12 patients with pelvic exenteration using LVSS. They found no coagulator-related complications and none of the patients had any complications necessitating reoperation. Likewise, Kössi et al17 performed a total of 112 laparoscopic splenectomies. The intraoperative and postoperative complications were similar in the LVSS group compared with the conventional group using monopolar coagulation and endostapler for preparation and hilar dissection.16 Compared with open radical prostatectomies and radical cystectomies with conventional dissection, Daskalopoulos et al15 found neither serious intraoperative nor postoperative complications related to the use of LVSS in a study of 58 patients. The reduced intraoperative blood loss in the LVSS group of our study relates favorably to the findings of other investigators who found a perioperative blood loss reduction of 143 mL in esophageal cancer resection,5 115 mL in laparoscopic splenectomy,16 116 mL in open radical prostatectomies, and 107 mL in radical cystectomies15 when using LVSS compared with conventional dissection technique. To date, the LVSS dissection technique has been described for certain steps of pancreatoduodenectomy, namely limited use for dissection of the mesenteric blood supply.14 Up to now, there has been only one single case reported by Belli et al,18 in which LVSS was used for the entire dissection procedure except for bowel transection. We applied the same technique, however, with the difference that LVSS also was used for bowel transection. There are few published reports of experiences using LVSS for bowel tran-
Table 3
section and the findings are inconsistent. Salameh et al19 compared 6 pigs with bowel transection performed with endoscopic linear stapling/cutting device with 6 pigs with bowel transection double-sealed with LVSS. They found that division of the small bowel with LVSS was unsafe and inefficient. Burst pressure for stapled segments was significantly higher than for segments cut with LVSS. In contrast, Smulders et al20 stated that creating an intestinal anastomosis using LVSS was feasible and safe. They performed 8 anastomoses with LVSS in 4 pigs and found macroscopic and microscopic intact anastomoses after 1 week. Because of the limited experiences published to date and the inconsistency of findings, we decided to overstitch the transected bowel in our LVSS group. By doing so, we were able to avoid any leaks. The most important benefit of LVSS might be related to its cost-cutting potential as a result of reduced surgical time. We had a mean reduction of 48 minutes, resulting in a mean cost savings of €806.5 in the LVSS group. The costs for material consumption were similar in the LVSS group, with a trend in favor of the conventional dissection technique. Considering that in the present study the LigaSure Atlas device was used, it is possible that in the future the Ligasure Impact with a faster technology will lead to even further reductions in surgical time and costs. Our experience relates favorably to other published data. Eroglu et al5 described a significant mean reduction in surgical time of 47 minutes in esophageal cancer resection compared with conventional surgery in a study of 60 patients. Saint Marc et al21 showed the same effect with a significant decrease in surgical time for 200 patients who had undergone total thyroidectomy. However, the 7-minute time savings in this uncomplicated surgery was too small to offset the higher material costs in the LVSS group. It seems that the more complex and time-
Costs in Euros (€)
Costs related to surgical time Costs related to material consumption Total variable costs related to the surgery*
LVSS group (n ⫽ 7)
Conventional group (n ⫽ 7)
P value
3,677.3 ⫾ 491.2 447.2 ⫾ 58.9 4,124.5 ⫾ 488
4,521.8 ⫾ 636.2 409.2 ⫾ 30.3 4,931 ⫾ 644.9
.020 .160 .023
Values shown are the mean ⫾ standard deviation. *Includes the expenses for personnel and the use of the operating room as well as the material consumption. Other direct or indirect costs were not included in the calculation because they were assumed to be equal in both groups.
170 consuming a procedure, the greater is the cost-saving effect of dissection with LVSS. Pancreatoduodenectomy, as in our study, seems to be a perfect example confirming that assumption. However, to draw a final conclusion in this regard, well-designed randomized controlled studies with adequate sample sizes are needed. Based on power analysis, 46 patients were needed in each group to detect a mean surgical time difference of 47 minutes between the 2 groups, with 80% power and a significance level of .05. In conclusion, the present pilot case-control study indicates that LVSS can be used safely and efficiently for virtually the entire PPW dissection technique. In addition, LVSS might lead to a reduction in the surgery-related costs mainly owing to the shorter surgical time needed in extended procedures such as pancreatoduodenectomy. However, to confirm these findings well-designed randomized controlled trials are needed in the future. The estimates obtained in the present study may be helpful in planning such trials.
Acknowledgments The authors have no financial or other related disclosures to declare. No external funds were used to perform the evaluation, and all of the tested technology was purchased separately to complete the study. In addition, the authors had full control of the design of the study, methods used, outcome measurements, analysis of data, and production of the written report.
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