Int Surg 2014;99:632–639 DOI: 10.9738/INTSURG-D-13-00078.1
Harmonic Curved Shears System Prevent of Bile Leakage After Liver Resection in a Pig Model Mitsugi Shimoda, Yoshimi Iwasaki, Keiichi Kubota Second Department of Surgery, Dokkyo Medical University, Mibu, Japan
We evaluated the efficacy of TachoComb (TC) collagen fleece and Harmonic Focus (HF) shears in a pig liver resection model. Pigs were divided into 3 groups of 7, in which vessels were tied with silk and TC was applied to the cut surfaces (SilkþTC group), sealed and sheared with HF and TC (HFþTC group), or sealed using HF alone (HF–TC group). After 1 month, we conducted a histologic evaluation and recorded the incidence of bile leakage with infected collections at the liver cut surface. Six pigs were evaluated in each group. In the SilkþTC group, 4 of the 6 pigs had infected collections at the cut surface. Histologically, the silk had remained under the fibrotic tissue, which contained remnants of TC fragments. In the HFþTC group, 5 of the 6 pigs also had infected collections, and histologically, TC had remained in the hard fibrotic tissues. In the HF–TC group, none of the 6 pigs had infected collections, and the histologic findings were normal. Use of the HF alone may be an effective method for preventing bile leakage in infected collections after liver resection. Key words: Shears system – Fibrinogen sheet – Liver resection – Pig – Biloma
S
ome liver centers commonly use collagen fleece with fibrin glue [TachoComb (TC) or TachoSill (TS) (CSL Behring, Tokyo, Japan)] to prevent bleeding during and after hepatectomy.1–3 However, it is still unclear whether TC is effective for preventing bile leakage from the cut surface of the liver. In recent years, the harmonic curved shears system has been widely used in laparoscopic surgery, and some reports have shown that it is effective for compress-
ing small vessels and lymph ducts, thus preventing lymphorrhea after lymph node dissection.4 In liver surgery, clamp crushing or a Cavitron Ultrasonic Surgical Aspirator (CUSA, Tyco Healthcare, Mansfield, Massachusetts) is commonly used during liver transection, and small vessels are usually tied with silk or sealed with vessel clips to prevent bile leakage and small-scale bleeding. The harmonic curved shears system (Harmonic Focus Ethicon
Corresponding author: Mitsugi Shimoda, MD, PhD, 880 Kita-kobayashi, Mibu, Tochigi 321-0293, Japan. Tel.: þ81 282 86 3537; Fax: þ81 282 86 6317; E-mail: [email protected]
632
Int Surg 2014;99
HARMONIC EFFECT FOR LIVER RESECTION
Endo-Surgery, Inc, Cincinnati, Ohio) is a new technology for vessel sealing and has not been evaluated for liver parenchymal transection in terms long-term morbidity after surgery. We report the results of a study we conducted to assess the efficacy of TC and Harmonic Focus (HF) shears in a pig liver resection model.
Material and Methods Experimental groups The study was performed using male pigs weighing 23 to 25 kg (SEASCO, Saitama, Japan), in accordance with the Guidelines for the Care and Use of Laboratory Animals, Dokkyo Medical University. After being administered ketamine hydrochloride (250 mg) and atropine (0.5 mg) intramuscularly, the pigs were intubated and ventilated mechanically at a tidal volume of 25 mL/kg and a rate of 12 breaths/ min. During the experiment, general anesthesia was maintained with a mixture of 1% to 2% isoflurane and 100% oxygen. Under general anesthesia, a chevron incision was performed and a left hemihepatectomy was performed (approximately 40%). Liver parenchyma was transected only, using the crush-clamping method. The stump of the left hepatic vein was closed with continuous sutures of 4-0 Proline (Ethicon Inc., Cincinnati, OH). In each group, we irrigated the intraperitoneal cavity with 1000 mL saline. The pigs were subsequently allocated randomly into 3 groups (n ¼ 7 in each): SilkþTC group, HFþTC group, and HF–TC group. SilkþTC group After crush-clamping of the liver parenchyma, all vessels and the small bile duct were tied with silk strings (2-0 or 3-0) then cut of vessels with scissors, and TC was applied to the resection surface. Small pieces of TC were applied to the cut liver surface with 3 minutes of gentle compression (Fig. 1a–1e). HFþTC group All vessels and the small bile duct were sealed and cut with the HF, and TC was also applied to the resection surface using the same method. HF–TC group All vessels and the small bile duct were sealed and divided with the HF, and TC was never Int Surg 2014;99
SHIMODA
applied to the resected surface (Fig. 2a and 2b). After surgery, pigs were cared for in an animal unit, and oral intake was started after the first postoperative day. We did not administer any kinds of antibiotics orally or intravenously after surgery, and the abdominal incision was not disinfected. After 1 month, we reopened the abdomen and conducted a histologic evaluation and recorded the incidence of bile leakage or inflammatory change at the cut surface of the liver. We also compared the amount of bleeding and the liver resection time between groups. Statistical analysis Associations between different categoric variables were assessed using Fisher exact test or the v2 test. Continuous variables were compared between the 2 groups using the Mann-Whitney U test or independent paired Student t test. P values ,0.05 were considered statistically significant.
Results Three of the 21 pigs died after surgery. In the SilkþTC group, a pig died of a strangulated bowel obstruction caused by ileum adhesion on the first postoperative day (POD). In the HF–TC group, a pig also died from a bowel obstruction at POD 2, and another pig died of severe jaundice with biliary obstruction at POD 8 in the HFþTC group. Finally, 6 pigs were evaluated in each group. There were no significant intergroup differences in body weight, the amount of intraoperative hemorrhage, liver resection time, or weight of the resected liver (Table 1). In the SilkþTC group, 4 of the 6 pigs had capsulated cavities at the cut surface. Inside these cavities, necrotic liver tissue and pieces of TC with bile juice were found (Fig. 3a–3d). Bacterial culture revealed Escherichia coli as a component of pus. Histologically, these capsules consisted of fibrotic collagenous tissue with fibroblast cells and edematous tissue and were completely separated from the normal liver parenchyma. Foreign-body reaction caused by silk was found in the fibrotic tissue close to the liver tissue (Fig. 3e and 3f). In the HFþTC group, 5 of the 6 pigs also had a capsulated cavity at the cut surface. These cavities also contained necrotic liver tissue with pus and pieces of TC (Fig. 4a–4d). Bacterial culture revealed E. coli and Pseudomonas aeruginosa as components of the pus. Histologically, the hard capsules were 633
SHIMODA
HARMONIC EFFECT FOR LIVER RESECTION
Fig. 1 (a) After liver resection, we controlled bleeding and bile leakage. Next, small pieces of TC were applied to the cut surface (b), followed by 3 minutes of compression (c); then all pieces of TC were attached to the cut surface (d).
composed of fibrotic tissue with myofibroblasts and fibroblasts and were completely separated from the normal liver parenchyma (Fig. 4e and 4f). In the HF–TC group, none of the 6 pigs had any form of infected collections (Fig. 5a), and the 634
incidences of bile leakage with fibrotic capsules and positive bacterial cultures were significantly lower than in the other 2 groups (Table 2). No infected collections or fibrotic tissues were evident on the cut surface (Fig. 5b and 5c). Int Surg 2014;99
HARMONIC EFFECT FOR LIVER RESECTION
SHIMODA
Fig. 2 (a) All small vessels were sealed and sheared with the HF. (b) None showed bile leakage or bleeding at the time of transection.
There were no significant differences in blood loss or operation time among the 3 groups (Table 3).
Discussion Hepatic resection is a challenging surgical procedure because of the high risk of bleeding during liver transection and the complicated nature of biliary anatomy.5 In the 1990s, preoperative patient selection based on liver functional reserve was
considered important, and the amounts of blood loss and perioperative transfusion were major factors impacting patient outcome.6 Bile leakage is a serious complication after major liver surgery7 as well as a major determinant of postoperative morbidity. It sometimes results in biloma formation at liver cut surface. With the use of mass coagulation devices and high-energy electronic knife coagulation, the bile duct cannot be easily identified in dark, charred liver, leading to a high incidence of severe bile leakage. Over the past 20 years, technologic advances have led to the development of specific instruments and devices for liver transection, such as the ultrasonic dissector, water jet, and Tissue-Link (Medtronic, Inc., USA) dissecting sealer. New intraoperative techniques have also contributed to reduction of blood loss during liver transection. After use of such devices, exposed small vessels have usually been ligated with silk ties and cut with scissors. The HF is a new form of ultrasonic surgical shear that cuts and coagulates at same time, using a lower temperature than those employed by electrosurgical devices. The HF employs mechanical vibration for simultaneous coagulation and tissue cutting, and has been employed successfully in several surgical fields.8,9 The harmonic scalpel contains a generator producing acoustic waves at a frequency of 55,000 Hz. These waves are transferred to the active blade of the instrument, vibrating harmoniously at the same frequency. In addition to the direct cutting action of the vibrating blade, ultrasound waves cause cavitation fragmentation of tissues and an additional cutting effect.10 The coagulation effect is due to tissue protein denaturation.11 The HF is associated with considerably lower production of thermal energy (up to 808C), thus causing significantly less damage to the adjacent tissue.12 This allows the surgeon to easily dissect as well as coagulate and cut vessels and bile ducts during liver surgery,13 sealing them without hindering the operative view. The present experimental study revealed that the HF could be helpful
Table 1 Comparison of perioperative factors SþT G (n ¼ 6) Body weight, kg Body weight (after 1 mo), kg Blood loss, mL Resection time, min Resected liver volume, g Liver volume (after 1 mo), g
25.5 28.3 90.7 27.6 292.1 543.8
6 6 6 6 6 6
1.3 0.8 62.7 5.4 24.1 57.5
FþT G (n ¼ 6) 24.3 27.5 85.0 26.8 297.5 535.7
6 6 6 6 6 6
1.0 2.4 64.8 6.3 53.0 85.2
F G (n ¼ 6) 27.8 31.3 102.1 31.9 352.4 599.2
6 6 6 6 6 6
1.9 2.6 75.3 7.9 57.5 79.3
P value 0.078 0.204 0.647 0.266 0.791 0.199
SþT G, SilkþTC group; FþT G, HFþTC group; F G, HF–TC group. Int Surg 2014;99
635
SHIMODA
Fig. 3
HARMONIC EFFECT FOR LIVER RESECTION
(a–f) Capsulated cavities revealed at the cut surface (a and c). When opened (arrow), the cavities contained carbonized necrotic
liver tissues, pieces of TC, and bile juice (b, forceps, and d). The capsules consisted of fibrotic collagenous tissue including edematous tissue, and silk remained at the bottom of the fibrotic tissue (f, circle), being completely separated from the normal liver parenchyma (both arrows, e and f). Original magnification 3200.
636
Int Surg 2014;99
HARMONIC EFFECT FOR LIVER RESECTION
Fig. 4
SHIMODA
(a–f) Small capsulated cavity revealed at the cut surface (a). Capsules contained white pus and included TC fragments (b) and
were completely separated from the normal liver parenchyma (c, d). Edematous fibrotic tissues included myoblasts and fibroblasts, completely separated from the normal liver parenchyma (both arrows, e and f). Original magnification 3200.
Int Surg 2014;99
637
SHIMODA
Fig. 5
HARMONIC EFFECT FOR LIVER RESECTION
(a–c) There were no capsulated cavities on the liver cut surface (a), and normal liver parenchyma was evident. Original
magnification (b) 3100, (c) 3200.
in preventing hemorrhage and bile leakage at the time of liver transection, without requiring the use of either electronic knife coagulation or suture ligation to control bleeding or bile leakage. Examination 1 month after surgery showed that use of the HF had prevented bile leakage as well as infected collections at the cut surface. Collagen-bound fibrin sealants have undergone several improvements in recent years. TC, the prototype collagen-bound fibrin sealant, became commercially available in the 1990s and proved to be effective for the management of bleeding during several forms of parenchymal transection in animals.3 It consisted of a sponge-like equine collagen patch containing a mixture of human fibrinogen, Table 2 Comparison of liver cut surface
Collections with F C, yes/no Bacterial culture, positive/negative
SþT G (n ¼ 6)
FþT G (n ¼ 6)
FG (n ¼ 6)
4/2*
5/1**
0/6
Table 3 Comparison of operative factors
4/2*
4/2*
0/6
Silk string G (n ¼ 6)
HF sealing G (n ¼ 12)
P value
90.7 6 62.7 27.6 6 5.4
93.0 6 67.9 27.0 6 8.3
0.939 0.850
F C, fibrotic capsule. SþT G, SilkþTC group; FþT G, HFþTC group; F G, HF–TC group. *P ¼ 0.014. **P ¼ 0.001.
638
bovine thrombin, and aprotinin. In 2004, the thirdgeneration form of TS was introduced. It differed only slightly in that aprotinin was removed, and all material of bovine origin was completely eliminated. Only TC is covered by the health insurance system in Japan. The clinical benefits of TC and TS have been demonstrated in a wide variety of procedures, including abdominal, endocrine, cardiothoracic, gynecologic, and trauma surgery. In abdominal surgery, particularly liver resection, there has been concern that excessive hemorrhage and blood transfusion may be associated with higher postoperative morbidity and mortality, as well as a less successful long-term outcome.6 Only one clinical study has compared TS with the use of an argon laser as a secondary treatment for bleeding during planned liver resection. TS was shown to facilitate significantly better control of bleeding than an argon laser at the liver cut surface.1 However, TS
Blood loss, mL Resection time, min G, group.
Int Surg 2014;99
HARMONIC EFFECT FOR LIVER RESECTION
was not effective in preventing bile leakage after resection in comparison with conventional techniques. In an experimental study using a pig partial liver resection model, Erdogan et al2 reported that TS was more effective than a liquid fibrin sealant for sealing bile ducts. However, that study involved evaluation for only a 2-hour period, so the long-term morbidity remained unclear. No clinical or experimental studies have investigated the effects of TS and TC application on bile leakage after liver resection. In our experimental study, we evaluated long-term morbidity and found that neither TC in addition to silk suture ligation nor TC with the new HF device was helpful in preventing bile leakage. Although TC was only effective in small bleeding in liver cut surface, our results suggest that the use of TC on cut surfaces after liver resection does not reduce bile leakage or abscess formation, and therefore cannot be recommended.
SHIMODA
experimental liver resection model in pigs. Eur Surg Res 2008; 41(3):298–302 3. Martis G, Miko I, Szendroi T, Kathy S, Kovacs J, Hajdu Z. Results with collagen fleece coated with fibrin glue (TachoComb): a macroscopical and histological experimental study. Acta Chir Hung 1997;36(1–4):221–222 4. Miccoli P, Materazzi G, Miccoli M, Frustaci G, Fosso A, Berti P. Evaluation of a new ultrasonic device in thyroid surgery: comparative randomized study. Am J Surg 2010;199(6):736–740 5. Poon RT, Fan ST. Hepatectomy for hepatocellular carcinoma: patient selection and postoperative outcome. Liver Transpl 2004;10(suppl 1):S39–S45 6. Kooby DA, Stockman J, Ben-Porat L, Gonen M, Jarnagin WR, Dematteo RP et al. Influence of transfusions on perioperative and long-term outcome in patients following hepatic resection for colorectal metastases. Ann Surg 2003;237(6):860–869; discussion 869–870 7. Reed DN Jr, Vitale GC, Wrightson WR, Edwards M, McMasters K. Decreasing mortality of bile leaks after elective hepatic surgery. Am J Surg 2003;185(4):316–318
Conclusions
8. Amaral JF. Laparoscopic cholecystectomy in 200 consecutive patients using an ultrasonically activated scalpel. Surg
Use of the HF alone may be an effective method for preventing bile leakage with infected collections after liver resection, whereas the use of TC on the cut liver surface remains of concern.
10. Amaral JF. Ultrasonic dissection. Endosc Surg Allied Technol
References
11. Wiatrak BJ, Willging JP. Harmonic scalpel for tonsillectomy.
Laparosc Endosc 1995;5(4):255–262 9. To EW, Pang PC, Lai EC, Tsang WM. The use of the harmonic scalpel for glossectomy. Br J Plast Surg 2001;54(6):553 1994;2(3–4):181–185 Laryngoscope 2002;112(8 pt 2, suppl 100):14–16
1. Frilling A, Stavrou GA, Mischinger HJ, de Hemptinne B,
12. Hambley R, Hebda PA, Abell E, Cohen BA, Jegasothy BV.
Rokkjaer M, Klempnauer J et al. Effectiveness of a new carrierbound fibrin sealant versus argon beamer as haemostatic
Wound healing of skin incisions produced by ultrasonically
agent during liver resection: a randomised prospective trial. Langenbecks Arch Surg 2005;390(2):114–120 2. Erdogan D, de Graaf W, van Gulik TM. Adhesive strength of fibrinogen-coated collagen patch or liquid fibrin sealant in an
Int Surg 2014;99
vibrating knife, scalpel, electrosurgery, and carbon dioxide laser. J Dermatol Surg Oncol 1988;14(11):1213–1217 13. Jagannath P, Chhabra DG, Sutariya KR, Shah RC. Fusion technique for liver transection with Kelly-clysis and harmonic technology. World J Surg 2010;34(1):101–105
639
Harmonic Curved Shears System Prevent of Bile Leakage After Liver Resection in a Pig Model Mitsugi Shimoda, Yoshimi Iwasaki, Keiichi Kubota Second Department of Surgery, Dokkyo Medical University, Mibu, Japan
We evaluated the efficacy of TachoComb (TC) collagen fleece and Harmonic Focus (HF) shears in a pig liver resection model. Pigs were divided into 3 groups of 7, in which vessels were tied with silk and TC was applied to the cut surfaces (SilkþTC group), sealed and sheared with HF and TC (HFþTC group), or sealed using HF alone (HF–TC group). After 1 month, we conducted a histologic evaluation and recorded the incidence of bile leakage with infected collections at the liver cut surface. Six pigs were evaluated in each group. In the SilkþTC group, 4 of the 6 pigs had infected collections at the cut surface. Histologically, the silk had remained under the fibrotic tissue, which contained remnants of TC fragments. In the HFþTC group, 5 of the 6 pigs also had infected collections, and histologically, TC had remained in the hard fibrotic tissues. In the HF–TC group, none of the 6 pigs had infected collections, and the histologic findings were normal. Use of the HF alone may be an effective method for preventing bile leakage in infected collections after liver resection. Key words: Shears system – Fibrinogen sheet – Liver resection – Pig – Biloma
S
ome liver centers commonly use collagen fleece with fibrin glue [TachoComb (TC) or TachoSill (TS) (CSL Behring, Tokyo, Japan)] to prevent bleeding during and after hepatectomy.1–3 However, it is still unclear whether TC is effective for preventing bile leakage from the cut surface of the liver. In recent years, the harmonic curved shears system has been widely used in laparoscopic surgery, and some reports have shown that it is effective for compress-
ing small vessels and lymph ducts, thus preventing lymphorrhea after lymph node dissection.4 In liver surgery, clamp crushing or a Cavitron Ultrasonic Surgical Aspirator (CUSA, Tyco Healthcare, Mansfield, Massachusetts) is commonly used during liver transection, and small vessels are usually tied with silk or sealed with vessel clips to prevent bile leakage and small-scale bleeding. The harmonic curved shears system (Harmonic Focus Ethicon
Corresponding author: Mitsugi Shimoda, MD, PhD, 880 Kita-kobayashi, Mibu, Tochigi 321-0293, Japan. Tel.: þ81 282 86 3537; Fax: þ81 282 86 6317; E-mail: [email protected]
632
Int Surg 2014;99
HARMONIC EFFECT FOR LIVER RESECTION
Endo-Surgery, Inc, Cincinnati, Ohio) is a new technology for vessel sealing and has not been evaluated for liver parenchymal transection in terms long-term morbidity after surgery. We report the results of a study we conducted to assess the efficacy of TC and Harmonic Focus (HF) shears in a pig liver resection model.
Material and Methods Experimental groups The study was performed using male pigs weighing 23 to 25 kg (SEASCO, Saitama, Japan), in accordance with the Guidelines for the Care and Use of Laboratory Animals, Dokkyo Medical University. After being administered ketamine hydrochloride (250 mg) and atropine (0.5 mg) intramuscularly, the pigs were intubated and ventilated mechanically at a tidal volume of 25 mL/kg and a rate of 12 breaths/ min. During the experiment, general anesthesia was maintained with a mixture of 1% to 2% isoflurane and 100% oxygen. Under general anesthesia, a chevron incision was performed and a left hemihepatectomy was performed (approximately 40%). Liver parenchyma was transected only, using the crush-clamping method. The stump of the left hepatic vein was closed with continuous sutures of 4-0 Proline (Ethicon Inc., Cincinnati, OH). In each group, we irrigated the intraperitoneal cavity with 1000 mL saline. The pigs were subsequently allocated randomly into 3 groups (n ¼ 7 in each): SilkþTC group, HFþTC group, and HF–TC group. SilkþTC group After crush-clamping of the liver parenchyma, all vessels and the small bile duct were tied with silk strings (2-0 or 3-0) then cut of vessels with scissors, and TC was applied to the resection surface. Small pieces of TC were applied to the cut liver surface with 3 minutes of gentle compression (Fig. 1a–1e). HFþTC group All vessels and the small bile duct were sealed and cut with the HF, and TC was also applied to the resection surface using the same method. HF–TC group All vessels and the small bile duct were sealed and divided with the HF, and TC was never Int Surg 2014;99
SHIMODA
applied to the resected surface (Fig. 2a and 2b). After surgery, pigs were cared for in an animal unit, and oral intake was started after the first postoperative day. We did not administer any kinds of antibiotics orally or intravenously after surgery, and the abdominal incision was not disinfected. After 1 month, we reopened the abdomen and conducted a histologic evaluation and recorded the incidence of bile leakage or inflammatory change at the cut surface of the liver. We also compared the amount of bleeding and the liver resection time between groups. Statistical analysis Associations between different categoric variables were assessed using Fisher exact test or the v2 test. Continuous variables were compared between the 2 groups using the Mann-Whitney U test or independent paired Student t test. P values ,0.05 were considered statistically significant.
Results Three of the 21 pigs died after surgery. In the SilkþTC group, a pig died of a strangulated bowel obstruction caused by ileum adhesion on the first postoperative day (POD). In the HF–TC group, a pig also died from a bowel obstruction at POD 2, and another pig died of severe jaundice with biliary obstruction at POD 8 in the HFþTC group. Finally, 6 pigs were evaluated in each group. There were no significant intergroup differences in body weight, the amount of intraoperative hemorrhage, liver resection time, or weight of the resected liver (Table 1). In the SilkþTC group, 4 of the 6 pigs had capsulated cavities at the cut surface. Inside these cavities, necrotic liver tissue and pieces of TC with bile juice were found (Fig. 3a–3d). Bacterial culture revealed Escherichia coli as a component of pus. Histologically, these capsules consisted of fibrotic collagenous tissue with fibroblast cells and edematous tissue and were completely separated from the normal liver parenchyma. Foreign-body reaction caused by silk was found in the fibrotic tissue close to the liver tissue (Fig. 3e and 3f). In the HFþTC group, 5 of the 6 pigs also had a capsulated cavity at the cut surface. These cavities also contained necrotic liver tissue with pus and pieces of TC (Fig. 4a–4d). Bacterial culture revealed E. coli and Pseudomonas aeruginosa as components of the pus. Histologically, the hard capsules were 633
SHIMODA
HARMONIC EFFECT FOR LIVER RESECTION
Fig. 1 (a) After liver resection, we controlled bleeding and bile leakage. Next, small pieces of TC were applied to the cut surface (b), followed by 3 minutes of compression (c); then all pieces of TC were attached to the cut surface (d).
composed of fibrotic tissue with myofibroblasts and fibroblasts and were completely separated from the normal liver parenchyma (Fig. 4e and 4f). In the HF–TC group, none of the 6 pigs had any form of infected collections (Fig. 5a), and the 634
incidences of bile leakage with fibrotic capsules and positive bacterial cultures were significantly lower than in the other 2 groups (Table 2). No infected collections or fibrotic tissues were evident on the cut surface (Fig. 5b and 5c). Int Surg 2014;99
HARMONIC EFFECT FOR LIVER RESECTION
SHIMODA
Fig. 2 (a) All small vessels were sealed and sheared with the HF. (b) None showed bile leakage or bleeding at the time of transection.
There were no significant differences in blood loss or operation time among the 3 groups (Table 3).
Discussion Hepatic resection is a challenging surgical procedure because of the high risk of bleeding during liver transection and the complicated nature of biliary anatomy.5 In the 1990s, preoperative patient selection based on liver functional reserve was
considered important, and the amounts of blood loss and perioperative transfusion were major factors impacting patient outcome.6 Bile leakage is a serious complication after major liver surgery7 as well as a major determinant of postoperative morbidity. It sometimes results in biloma formation at liver cut surface. With the use of mass coagulation devices and high-energy electronic knife coagulation, the bile duct cannot be easily identified in dark, charred liver, leading to a high incidence of severe bile leakage. Over the past 20 years, technologic advances have led to the development of specific instruments and devices for liver transection, such as the ultrasonic dissector, water jet, and Tissue-Link (Medtronic, Inc., USA) dissecting sealer. New intraoperative techniques have also contributed to reduction of blood loss during liver transection. After use of such devices, exposed small vessels have usually been ligated with silk ties and cut with scissors. The HF is a new form of ultrasonic surgical shear that cuts and coagulates at same time, using a lower temperature than those employed by electrosurgical devices. The HF employs mechanical vibration for simultaneous coagulation and tissue cutting, and has been employed successfully in several surgical fields.8,9 The harmonic scalpel contains a generator producing acoustic waves at a frequency of 55,000 Hz. These waves are transferred to the active blade of the instrument, vibrating harmoniously at the same frequency. In addition to the direct cutting action of the vibrating blade, ultrasound waves cause cavitation fragmentation of tissues and an additional cutting effect.10 The coagulation effect is due to tissue protein denaturation.11 The HF is associated with considerably lower production of thermal energy (up to 808C), thus causing significantly less damage to the adjacent tissue.12 This allows the surgeon to easily dissect as well as coagulate and cut vessels and bile ducts during liver surgery,13 sealing them without hindering the operative view. The present experimental study revealed that the HF could be helpful
Table 1 Comparison of perioperative factors SþT G (n ¼ 6) Body weight, kg Body weight (after 1 mo), kg Blood loss, mL Resection time, min Resected liver volume, g Liver volume (after 1 mo), g
25.5 28.3 90.7 27.6 292.1 543.8
6 6 6 6 6 6
1.3 0.8 62.7 5.4 24.1 57.5
FþT G (n ¼ 6) 24.3 27.5 85.0 26.8 297.5 535.7
6 6 6 6 6 6
1.0 2.4 64.8 6.3 53.0 85.2
F G (n ¼ 6) 27.8 31.3 102.1 31.9 352.4 599.2
6 6 6 6 6 6
1.9 2.6 75.3 7.9 57.5 79.3
P value 0.078 0.204 0.647 0.266 0.791 0.199
SþT G, SilkþTC group; FþT G, HFþTC group; F G, HF–TC group. Int Surg 2014;99
635
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Fig. 3
HARMONIC EFFECT FOR LIVER RESECTION
(a–f) Capsulated cavities revealed at the cut surface (a and c). When opened (arrow), the cavities contained carbonized necrotic
liver tissues, pieces of TC, and bile juice (b, forceps, and d). The capsules consisted of fibrotic collagenous tissue including edematous tissue, and silk remained at the bottom of the fibrotic tissue (f, circle), being completely separated from the normal liver parenchyma (both arrows, e and f). Original magnification 3200.
636
Int Surg 2014;99
HARMONIC EFFECT FOR LIVER RESECTION
Fig. 4
SHIMODA
(a–f) Small capsulated cavity revealed at the cut surface (a). Capsules contained white pus and included TC fragments (b) and
were completely separated from the normal liver parenchyma (c, d). Edematous fibrotic tissues included myoblasts and fibroblasts, completely separated from the normal liver parenchyma (both arrows, e and f). Original magnification 3200.
Int Surg 2014;99
637
SHIMODA
Fig. 5
HARMONIC EFFECT FOR LIVER RESECTION
(a–c) There were no capsulated cavities on the liver cut surface (a), and normal liver parenchyma was evident. Original
magnification (b) 3100, (c) 3200.
in preventing hemorrhage and bile leakage at the time of liver transection, without requiring the use of either electronic knife coagulation or suture ligation to control bleeding or bile leakage. Examination 1 month after surgery showed that use of the HF had prevented bile leakage as well as infected collections at the cut surface. Collagen-bound fibrin sealants have undergone several improvements in recent years. TC, the prototype collagen-bound fibrin sealant, became commercially available in the 1990s and proved to be effective for the management of bleeding during several forms of parenchymal transection in animals.3 It consisted of a sponge-like equine collagen patch containing a mixture of human fibrinogen, Table 2 Comparison of liver cut surface
Collections with F C, yes/no Bacterial culture, positive/negative
SþT G (n ¼ 6)
FþT G (n ¼ 6)
FG (n ¼ 6)
4/2*
5/1**
0/6
Table 3 Comparison of operative factors
4/2*
4/2*
0/6
Silk string G (n ¼ 6)
HF sealing G (n ¼ 12)
P value
90.7 6 62.7 27.6 6 5.4
93.0 6 67.9 27.0 6 8.3
0.939 0.850
F C, fibrotic capsule. SþT G, SilkþTC group; FþT G, HFþTC group; F G, HF–TC group. *P ¼ 0.014. **P ¼ 0.001.
638
bovine thrombin, and aprotinin. In 2004, the thirdgeneration form of TS was introduced. It differed only slightly in that aprotinin was removed, and all material of bovine origin was completely eliminated. Only TC is covered by the health insurance system in Japan. The clinical benefits of TC and TS have been demonstrated in a wide variety of procedures, including abdominal, endocrine, cardiothoracic, gynecologic, and trauma surgery. In abdominal surgery, particularly liver resection, there has been concern that excessive hemorrhage and blood transfusion may be associated with higher postoperative morbidity and mortality, as well as a less successful long-term outcome.6 Only one clinical study has compared TS with the use of an argon laser as a secondary treatment for bleeding during planned liver resection. TS was shown to facilitate significantly better control of bleeding than an argon laser at the liver cut surface.1 However, TS
Blood loss, mL Resection time, min G, group.
Int Surg 2014;99
HARMONIC EFFECT FOR LIVER RESECTION
was not effective in preventing bile leakage after resection in comparison with conventional techniques. In an experimental study using a pig partial liver resection model, Erdogan et al2 reported that TS was more effective than a liquid fibrin sealant for sealing bile ducts. However, that study involved evaluation for only a 2-hour period, so the long-term morbidity remained unclear. No clinical or experimental studies have investigated the effects of TS and TC application on bile leakage after liver resection. In our experimental study, we evaluated long-term morbidity and found that neither TC in addition to silk suture ligation nor TC with the new HF device was helpful in preventing bile leakage. Although TC was only effective in small bleeding in liver cut surface, our results suggest that the use of TC on cut surfaces after liver resection does not reduce bile leakage or abscess formation, and therefore cannot be recommended.
SHIMODA
experimental liver resection model in pigs. Eur Surg Res 2008; 41(3):298–302 3. Martis G, Miko I, Szendroi T, Kathy S, Kovacs J, Hajdu Z. Results with collagen fleece coated with fibrin glue (TachoComb): a macroscopical and histological experimental study. Acta Chir Hung 1997;36(1–4):221–222 4. Miccoli P, Materazzi G, Miccoli M, Frustaci G, Fosso A, Berti P. Evaluation of a new ultrasonic device in thyroid surgery: comparative randomized study. Am J Surg 2010;199(6):736–740 5. Poon RT, Fan ST. Hepatectomy for hepatocellular carcinoma: patient selection and postoperative outcome. Liver Transpl 2004;10(suppl 1):S39–S45 6. Kooby DA, Stockman J, Ben-Porat L, Gonen M, Jarnagin WR, Dematteo RP et al. Influence of transfusions on perioperative and long-term outcome in patients following hepatic resection for colorectal metastases. Ann Surg 2003;237(6):860–869; discussion 869–870 7. Reed DN Jr, Vitale GC, Wrightson WR, Edwards M, McMasters K. Decreasing mortality of bile leaks after elective hepatic surgery. Am J Surg 2003;185(4):316–318
Conclusions
8. Amaral JF. Laparoscopic cholecystectomy in 200 consecutive patients using an ultrasonically activated scalpel. Surg
Use of the HF alone may be an effective method for preventing bile leakage with infected collections after liver resection, whereas the use of TC on the cut liver surface remains of concern.
10. Amaral JF. Ultrasonic dissection. Endosc Surg Allied Technol
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