Incidence, Diagnostics and Management of Iatrogenic Bile Duct Injuries: 20 Years Experience in a High Volume Centre

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1 RETROSPECTIVE ANALYSIS Hellenic Journal of Surgery (2015) 87:2, Incidence, Diagnostics and Management of Iatrogenic Bile Duct Injuries: 20 Years Experience in a High Volume Centre E. Perrakis, N. Rapti, P. Ioannidis, G. Rallis, K. Papadopoulos, E. Alifierakis, A. Perrakis Abstract Background-Aim: The vast majority of bile duct injuries occur in cases of open or laparoscopic cholecystectomy. Numerous reports have demonstrated that the incidence of iatrogenic bile duct injuries (IBDI) has risen from 0.3% to 0.6% since the introduction of laparoscopic cholecystectomy. There are many classifications of iatrogenic bile duct injuries, none of which is universally accepted as each has its own limitation. The aim of the present study is to present the results of our investigation of this clinical topic and to propose a therapeutic algorithm for IBDI, considering the time of treatment, diagnosis and multimodal therapy of these lesions. Patients-Methods: A retrospective single institution analysis was conducted involving 5456 patients who underwent laparoscopic cholecystectomy from 1992 to Results: A total of five patients suffered biliary injuries (one male, four females) out of 5456 patients submitted to laparoscopic cholecystectomies, accounting for an overall incidence of 0.09%. All injuries were detected intraoperatively, and the laparoscopic cholecystectomy was converted to an open procedure. The mean hospital stay was 38 days. All five cases involved major bile duct injury: either complete transection of the common bile duct or common hepatic duct. Three cases were treated by end-to-end ductal biliary anastomosis and two by Roux-en-Y hepaticojejunostomy. There was no perioperative mortality. Conclusion: The management of iatrogenic biliary duct injuries depends on the time of diagnosis of the injury, the type of the injury, the general condition of the patient, and finally on a clear therapeutic algorithm set by an experienced team in a high volume centre Key words: Iatrogenic bile duct injuries; laparoscopic cholecystectomy Introduction Laparoscopic cholecystectomy (LC) is the current treatment of choice for symptomatic uncomplicated gallstone disease, chronic cholecystitis and for selected patients suffering acute cholecystitis without complications in terms of perforation and clinical symptoms of an acute abdomen. Compared to open surgery, laparoscopy provides many benefits for the patients. However, the role of laparoscopic E. Perrakis MD, Nikoletta Rapti MD, P. Ioannidis MD, G. Rallis MD, K. Papadopoulos MD, E. Alifierakis MD 1 st Surgical Department, Nikaia General Hospital, Piraeus, Nikaia, Greece A. Perrakis MD Department of Surgery, University Hospital Erlangen, Erlangen, Germany Corresponding author: N. Rapti, M.D. 1 st Surgical Department, Nikaia General Hospital, Piraeus, Greece Madouvalou str. 3, GR Pireaus, Greece Tel.: Fax: , nicoledoc@gmail.com Received 22 Nov 2014; Accepted 19 Dec 2014 cholecystectomy in all forms of acute cholecystitis has yet to be established. With increasing experience in laparoscopic surgery, a number of centres have reported on the use of laparoscopic cholecystectomy for acute cholecystitis [1,2], suggesting that it is technically feasible and safe. Unfortunately, LC has been associated with a significant increase in bile duct injuries reaching 0.6% [3]. Although most injuries occur within the surgeon s learning curve in LC, one third can happen after the surgeon has performed more than 200 procedures, signifying that inexperience is not the only reason for bile duct injuries [4]. There are many classifications for iatrogenic bile duct injuries (IBDI). IBDI are mostly classified according to the Bismuth scale. None of the proposed classifications is universally accepted as each has its own limitation [5]. All the proposed classification criteria are intended to help the surgeon in the right choice of the appropriate technique for surgical therapy of the IBDI. The early and accurate diagnosis of IBDI is of great importance in terms of immediate, appropriate treatment and avoidance of serious postoperative complications which

2 Iatrogenic Bile Duct Injuries: 20 Years Experience 145 can lead to early and late morbidity. The intention of such management is the satisfactory postoperative result which allows a good quality of life for these patients. We present our experience of more than 20 years with 5456 LCs, and we describe the biliary injuries sustained during the procedure and their management. The aim of the present study is to present the results of our investigation and to propose a therapeutic algorithm for IBDI, considering the time of treatment, diagnosis and multimodal therapy of these lesions. Patients - Methods Between January 1992 and December 2012, 5456 LCs were performed in our Surgical Department. Patients were identified from a prospective database and were retrospectively analyzed. All these cases were retrospectively searched for IBDI. We analyzed demographic data, clinical presentation and management of the injury, morbidity, mortality, hospital stay and follow-up evaluation. The injuries were classified according to the Strasberg classification [5,6]. Results A total of five biliary injuries were indentified, accounting for an overall incidence of 0.09%. The patients age ranged between 30 and 67 years (mean 46 years). According to distribution by gender, the female: male ratio was 4:1 (one male and four females). A total of three patients underwent LC due to uncomplicated gallbladder disease and two were submitted to surgery for acute cholecystitis. According to our database, all five injuries were diagnosed intraoperatively and laparoscopic cholecystectomy was converted to an open procedure. All patients suffered a Strasberg type E1 (transection) injury, which was detected immediately after transection by a biliary leakage. Neither a cholangiography nor intraoperative ultrasound examination was performed. Three of these patients underwent an end-to-end choledocho-choledochostomy with T-tube placement (Figure 1), and two were treated with an end to side Roux-en-Y hepaticojejunostomy. After the treatment of the IBDI, 60% of the patients developed either early or late postoperative complications. One patient who underwent a Roux-en-Y hepaticojejunostomy developed biliary leakage and peritonitis on postoperative day 2, necessitating a Rodney-Smith procedure with a high intrahilar biliaryenteric anastomosis. In another patient who underwent end-to end choledocho-choledochostomy, biliary leakage was registered on postoperative day 3 (Figure 2). The amount of leakage gradually decreased, but because of its persistence, ERC (endoscopic retrograde cholangiography) and the placement of a stent was decided (Figure 3). Finally, the last patient developed stenosis of the common bile duct eight months after an end-to-end anastomosis and a Rouxen-Y hepaticojejunostomy was performed. The mean hospital stay varied considerably, from 10 to 78 days, with an average of 31 days. The first T-tube radiologic control took place 14 days after surgery; lack of Figure 1. End-to-end common bile duct anastomosis over a T-tube. Figure 2. Cholangiography through the T-tube.

3 146 E. Perrakis et al. Figure 3. ERC and stent. leakage enabled its removal in 2-6 weeks. In cases involving ERC and placement of an intraluminal stent, the stent could be removed in six weeks after intervention. All our patients were followed up for three months to one year and no further complications were reported. No mortality was recorded in our series. Discussion There are two main groups of surgical procedures leading to IBDI. The first group involves surgical procedures performed on the biliary tract (open cholecystectomy, laparoscopic cholecystectomy). The second group involves operations performed on other organs, such as gastrectomy, hepatectomy and pancreas procedures. Bile duct injury following cholecystectomy is a surgical challenge, unfortunately associated with high perioperative morbidity and mortality [7]. After the introduction and widespread use of LC in 1990s, and its use in the treatment of acute cholecystitis in the last two decades, the number of patients with IBDI has increased. Kaman et al. [3] found a 0.3% incidence of major bile duct injuries during the open cholecystectomy era, as opposed to 0.6% for LC. Savader et al. [7] reported that treatment for LC-related bile duct injuries can be 4.5 to 26 times the cost of an uncomplicated procedure. However, intraoperative recognition of such an injury and immediate conversion to an open procedure and defini- tive repair is of great importance as far as peri- and postoperative morbidity and mortality is concerned. The role of routine intraoperative cholangiography is controversial. Some reports claim that the routine use of cholangiography by inexperienced surgeons or in cases of complicated disease is cost-effective [8] inasmuch as it lowers the risk of injury, but others do not concur with this view [9]. Despite this controversy, there is reasonable evidence to show that intraoperative cholangiography is likely to indentify the injury at the time of surgery [4]. We have not used intraoperative cholangiography (ICG) in our series because all IBDI registered in our institution were obvious to the surgeon; hence, the use of the ICG was deemed unnecessary. In a short review of the literature, acute cholecystitis was found to correlate strongly with biliary injury during LC [10]. Other poor prognostic factors included male gender, obesity, and prolonged course of disease before cholecystectomy [11]. In our series, 40% of patients with IBDI had an acute cholecystitis and all underwent surgery during the first 48 hours of the acute attack; only one was male. Several classifications of bile duct injury have been proposed, but none have been accepted as a universal gold standard [5]. None of the proposed classifications consider a vascular injury, which has been described only recently [5,12]. In our series, we used the commonly used Strasberg classification which is based on the traditional Bismuth classification. Zvonimir et al. [13] reported 12 iatrogenic bile duct injuries among 2657 LCs. According to their findings, 33% of the injuries were recognized intraoperatively, the most common type being complete transection. We were able to identify all injuries intraoperatively and treat them during the same surgical procedure. Management depends on the time of recognition of the injury. In cases of recognition during LC, immediate conversion to an open procedure should be performed in order to define the extent of the injury. If a major injury is suspected, an experienced surgical team in a high volume centre should be involved, because the outcome is likely to be significantly better, as reported by several authors [4,11]. The goal of surgery is the reconstruction of the biliary tract. Interruption of the common hepatic duct or common bile duct continuity can be repaired by immediate tension-free end-to-end anastomosis with or without a T-tube, using absorbable sutures. The anastomosed edges should be healthy without inflammation or ischaemia [11]. Primary repair over a T- tube may result in an insufficient postoperative outcome, combined with biliary leakage [14]. We reported complications (biliary leakage and stenosis) in two of a total of three patients who underwent primary repair over T-tube. In these cases, the procedure of choice

4 Iatrogenic Bile Duct Injuries: 20 Years Experience 147 is ERC, intraluminal stenting combined with duodenal sphincterotomy with or without placement of a nasobiliary tube. Endoscopic stenting has a role in the management of minor injuries. In a review of the literature, endoscopic intervention may provide a useful adjunct to surgery in certain situations [4]. We performed ERC and stenting in one patient after reconstruction with an end-to-end anastomosis with good results. If there is a proximal lesion or transection of the common bile duct, a reconstruction in the form of hepaticojejunostomy (HJ) is required. Currently, Roux-en-Y HJ is the most frequently performed surgical reconstruction of IBDI. In this technique, a proximal common bile duct is indentified and prepared, in order to perform an endto-side or end-to-end anastomosis in a single layer using absorbable sutures [15]. Both techniques have disadvantages and advantages. The repair of hilar IBDI requires special surgical techniques; the Blumgart-Hepp technique is currently used. There are several methods of biliary drainage securing the anastomosis [11]. In order to treat a biliary leak after a high intrahilar HJ, we used the Rodney Smith procedure. Two straight rubber tubes split the anastomosis and were passed via the hepatic ducts through the abdominal wall. In conclusion, laparoscopic cholecystectomy is the treatment of choice for symptomatic cholelithiasis, but it is associated with an increased incidence of bile duct injuries in comparison to conventional cholecystectomy. Every surgeon should be alert to these complications and be aware of the evidence suggesting the immediate involvement of an experienced hepatobiliary surgeon. A hepaticojejunostomy is the treatment of choice if a tension free end-to-end anastomosis with the placement of a T-tube of the common hepatic duct or of the common bile duct is not possible. Furthermore, we suggest immediate treatment of IBDI by converting to open surgery. If the lesion is not clinically identifiable, an ICG should be performed. In cases of a complicated postoperative course,and especially in cases of uncomplicated biliary leakage, an ERC with stent placement with or without placement of a nasobiliary tube needs to be performed. In cases of diffuse peritonitis with clinical impairment of the patient, we suggest the surgical treatment. Ethical Approval Ethical approval was obtained from our institutional ethics committee References 1. Cox MR, Wilson TG, Luck AJ, Jeans PL, Padbury RT, Toouli J. Laparoscopic cholecystectomy for acute inflammation of the gallbladder. Ann Surg 1993;218: Kolla SB, Aggarwal S, Kumar A, et al. Early versus delayed laparoscopic cholecystectomy for acute cholecystitis: a prospective randomized trial. Surg Endosc 2004;18: Epub 2004 Jul Kaman L, Sanyal S, Behera A, Singh R, Katariya RN. Comparison of major bile duct injuries following laparoscopic cholecystectomy and open cholecystectomy. ANZ J Surg 2006;76: Connor S, Garden OJ. Bile duct injury in the era of laparoscopic cholecystectomy. Br J Surg 2006;93: Lau WY, Lai EC. Classification of iatrogenic bile duct injury. Hepatobiliary Pancreat Dis Int 2007;6: Strasberg SM, Hertl M, Soper NJ. An analysis of the problem of biliary injury during laparoscopic cholecystectomy. J Am Coll Surg 1995;180: Savader SJ, Lillemoe KD, Prescott CA, et al. Laparoscopic cholecystectomy-related bile duct injuries: a health and financial disaster. Ann Surg 1997;225: Flum DR, Flowers C, Veenstra DL. A cost-effectiveness analysis of intraoperative cholangiography in the prevention of bile duct injury during laparoscopic cholecystectomy. J Am Coll Surg 2003;196: Nuzzo G, Giuliante F, Glovannini I, et al. Bile duct injury during laparoscopic cholecystectomy: results of an Italian national survey on 56,591 cholecystectomies. Arch Surg 2005;140: Adamsen S, Hansen OH, Funch-Jensen P, Schulze S, Stage JG, Wara P. Bile duct injury during laparoscopic cholecystectomy: a prospective nationwide series. J Am Coll Surg 1997;184: Beata J, Paweł L. Iatrogenic bile duct injuries: Etiology, diagnosis and management. W J Gastroenterol 2009;15: Stewart L, Robinson TN, Lee CM, Liu K, Whang K, Way LW. Right hepatic artery injury associated with laparoscopic bile duct injury: incidence, mechanism, and consequences. J Gastrointest Surg 2004;8: Zvonimir P, Tomislav K, Bjorn DF, Hrvoje H, Aljosa M, Miroslav BB. Bile duct injuries during open and laparoscopic cholecystectomy at Sestre Milosrdnice University Hospital from 1995 till Acta Clin Croat 2003;42: Stewart L, Way LW. Bile duct injuries during laparoscopic cholecystectomy. Factors that influence the results of treatment. Arch Surg 1995;130: Jabłońska1 B, Lampe1 P, Olakowski1 M, Lekstan1 A, Górka Z. Surgical treatment of iatrogenic biliary injuries early complications. Pol J Surg 2008;80: Conflict of interest The authors declare that they have no conflict of interest.

5 ΑΝΑΔΡΟΜΙΚΗ ΜΕΛΕΤΗ Hellenic Journal of Surgery (2015) 87:2, Ιατρογενείς Κακώσεις Εξωηπατικών Χοληφόρων: 20 Χρόνια Εμπειρία Ε. Περράκης, Ν. Ράπτη, Π. Ιωαννίδης, Γ. Ράλλης, Κ. Παπαδόπουλος, Ε. Αλιφιεράκης, Α. Περράκης Περίληψη Εισαγωγή: Η μεγάλη πλειοψηφία των κακώσεων των εξωηπατικών χοληφόρων είναι ιατρογενείς και συμβαίνει συνηθέστερα κατά την διάρκεια λαπαροσκοπικής ή ανοιχτής χολοκυστεκτομής. Για την ανοιχτή χολοκυστεκτομή η επίπτωση είναι 0,3%, ενώ για την λαπαροσκοπική 0,6%, όπως αναφέρεται στην διεθνή βιβλιογραφία. Υπάρχουν πολλές ταξινομήσεις των κακώσεων των εξωηπατικών χοληφόρων, αλλά καμία δεν είναι διεθνώς αποδεκτή. Οι ταξινομήσεις έχουν ως σκοπό να καθοδηγήσουν τον χειρουργό να επιλέξει την κατάλληλη θεραπεία και να αποφύγει τις επιπλοκές. Η άμεση χειρουργική αντιμετώπιση είναι επιβεβλημένη. Σκοπός: Οι συγγραφείς παρουσιάζουν την εικοσαετή εμπειρία τους από τις κακώσεις των εξωηπατικών χοληφόρων. Υλικό - Μέθοδος: Αναδρομική μελέτη όλων των ασθενών που υποβλήθηκαν σε λαπαροσκοπική χολοκυστεκτομή το χρονικό διάστημα από την ίδια χειρουργική ομάδα. Αποτελέσματα: Από το σύνολο των χειρουργηθέντων ασθενών Ν=5.456 διαγιγνώστηκαν 5 περιστατικά με κάκωση των εξωηπατικών χοληφόρων, επίπτωση 0,09%. Από αυτούς ο ένας ήταν άνδρας και οι 4 γυναίκες, ο μέσος όρος ηλικίας τους ήταν 46 έτη και ο μέσος χρόνος νοσηλείας τους ήταν 31 ήμερες. Από τα πέντε αυτά περιστατικά, τα 3 υποβλήθηκαν σε λαπαροσκοπική χολοκυστεκτομή λόγω ασυμπτωματικής χολολιθίασης, ενώ τα εναπομείναντα δύο σε έδαφος οξείας χολοκυστίτιδας. Όλα τα περιστατικά έφεραν μείζονα κάκωση-πλήρη διατομή του κοινού ηπατικού πόρου ή του χοληδόχου πόρου. Διεγχειρητική διάγνωση της κάκωσης έγινε σε όλα τα περιστατικά και άμεσα η λαπαροσκοπική χολοκυστεκτομή μετατράπηκε σε ανοιχτή επέμβαση, χωρίς την διενέργεια διεγχειρητικής χολαγγειογραφίας. Δύο περιστατικά υπεβλήθηκαν σε χολοπεπτική αναστόμωση κατά Roux en Y και τρία σε τελικοτελική αναστόμωση. Άμεσα μετεγχειρητικά δύο περιστατικά παρουσίασαν χολόρροια, ενώ σε απώτερο χρόνο ένα εμφάνισε στένωση χοληδόχου πόρου. Δεν υπήρξε κανένας θάνατος. Συμπεράσματα: Η αντιμετώπιση των κακώσεων των εξωηπατικών χοληφόρων εξαρτάται από το χρόνο αναγνώρισης της κάκωσης, το τύπο της κάκωσης, τη γενική κατάσταση του ασθενούς και την διαθεσιμότητα του κατάλληλου και έμπειρου χειρουργού. Η παρουσία οξείας χολοκυστίτιδας μπορεί να αυξάνει τις πιθανότητες κάκωσης των εξωηπατικών χοληφόρων. Οι κακώσεις των εξωηπατικών χοληφόρων πρέπει να αντιμετωπίζονται σε εξειδικευμένα κέντρα, όπου οι χειρουργοί είναι εξοικειωμένοι με αυτές τις επιπλοκές. Η χολοπεπτική αναστόμωση θεωρείται η θεραπεία εκλογής, αν η τελικο-τελική αναστόμωση χωρίς τάση του χοληδόχου πόρου ή του κοινού ηπατικού πόρου δεν είναι εφικτή. Λεξεις κλειδιά: Ιατρογενείς κακώσεις χοληφόρων, λαπαροσκοπική χολοκυστεκτομή Ε. Περράκης, Ν. Ράπτη, Π. Ιωαννίδης, Γ. Ράλλης, Κ. Παπαδόπουλος, Ε. Αλιφιεράκης Α Χειρουργικό Τμήμα, Γ.Ν. Νίκαιας, Πειραιάς Α. Περράκης Χειρουργικό Τμήμα, Πανεπιστημιακό Νοσοκομείο Erlangen, Γερμανία