Rate Of Bile Duct Injury Research Articles

Frequency of biliary complications after laparoscopic cholecystectomy detected by ERCP: experience at a large tertiary referral center

Laparoscopic cholecystectomy has a higher incidence of bile-duct injuries than open cholecystectomy. Although a learning curve phenomenon was attributed to biliary injuries early after its introduction, we were interested in trends in biliary injury rates over time as laparoscopic cholecystectomy has become a mature technology. To analyze the frequency and anatomic distribution of bile-duct injuries referred after laparoscopic cholecystectomy over a 10-year period. Retrospective, case-series. Tertiary, referral hepatobiliary unit. Referrals to ERCP unit for diagnosis and treatment of biliary injuries after laparoscopic cholecystectomy. ERCP to diagnose level and severity of bile duct injury. Type and anatomy of bile-duct injury, reason for cholecystectomy, mean time between injury and diagnosis, presenting symptoms, ratio of bile-duct injuries diagnosed over total ERCPs done per year. There were 87 bile-duct leaks, 28 leaks with stones, 51 strictures, and 17 complete duct transactions. The bile-duct injury rate calculated per 100 ERCPs per year was 0.84 (1994), 0.99 (1995), 1.36 (1996), 1.41 (1997), 1.03 (1998), 1.31 (1999), 0.84 (2000), 0.75 (2001), 1.15 (2002), and 0.94 (2003). Single institution, retrospective analysis, unknown denominator of cholecystectomies done in referral area per year to calculate true bile-duct injury rate. Static incidence in frequency, anatomic distribution, and rate per 100 ERCPs per year of postcholecystectomy bile-duct injuries at a tertiary referral hepatobiliary unit over a 10-year period of observation.

Video Trainers, Simulation and Virtual Reality: A New Paradigm for Surgical Training

William S. Halsted established an educational system of graded learning in which surgical postgraduate trainees would, over time, do more and more of an operation as their training progressed. The apprentice model has been in place ever since, but economic pressures and work hour limitations have competed to hurry training along. A popular surgical adage is “see one, do one, teach one”, and under this model, trainees after very limited experience would be empowered to perform procedures on patients. The apprentice model may no longer be working. The National Academy of Science in 1999 and its publication To Err is Human noted that approximately 98,000 deaths occur each year due to medical error.1 In fact, they identified error in the performance of an operation as one of the many causes of mortality. The Institution of Medicine further challenged that alternative methods of surgical training needed to be developed. The cost of training is not cheap. Bridges et al broke down the financial impact of teaching surgical residents in the operating room.2 In 9,733 cases with residents versus 4,719 cases without residents, they found that cases with residents took an additional 12 minutes per case. In their analysis, they charged US$4.29/minute and assumed 1,014 US residents. The cost to society was US$53 million per year to train surgical residents in the operating room. No wonder as we scrutinize costs in the operating room, the most expensive “instrument” seems to be operative time. Halsted’s apprentice model of graded learning seems to work with general surgery in that trainees begin by making the incision, tying a knot, tying a series of knots and then performing simple procedures and eventually complex operations. However, these “open” hand skills are not transferable to laparoscopic procedures. The master “open” general surgeon may not be able to perform the most basic of laparoscopic procedures safely. Laparoscopy uses fixed ports with elongated instruments. Laparoscopy lacks the same tactile feedback and often uses a twodimensional visual system. Tying a traditional two-handed knot does not mean that the surgeon can tie an intracorporeal laparoscopic knot. So simply waiting for a junior resident to become a senior resident does not mean that they would then have the ability to perform laparoscopic surgery. Learning these techniques in the operating room may also prove too costly to the hospital; therefore, new techniques and ideas about how to train surgeons had to evolve. The laparoscopic revolution began in 1987 with laparoscopic cholecystectomy. In the early 1990s, thousands of surgeons began to embark on this new field. Most surgeons would take a weekend course which included operating on a pig before bringing the new instruments into the operating theatre for their next case. Unfortunately, the rate of common bile duct injuries increased five-fold as surgeons not expert in these techniques took on new

Laparoscopic biliary tract injury: what are the limits of prevention?

At the joint meeting of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and the American Hepato-Pancreatic-Biliary Association in April 2005, the program committee convened a forum on the subject of biliary injuries that occur during laparoscopic cholecystectomy. More than 300 surgeons attended this forum, and the discussion was lively, indicating that this topic still is important to practicing surgeons. The editors of Surgical Endoscopy have agreed to publish the papers from this forum in this issue of the journal [1, 2, 5, 6, 8]. There are two articles on the prevention of biliary injuries during cholecystectomy and there are three papers on methods for diagnosing, evaluating, and treating the problem once it has occurred. The editors are to be commended for agreeing to print these proceedings because, they are written by experts in the field and are very informative to all surgeons who treat patients with biliary tract disease. The questions are (1) How safe can we make laparoscopic cholecystectomy? and (2) How much can we reduce the rate of bile duct injury? The answer to both questions is that laparoscopic cholecystectomy should certainly be as safe as open cholecystectomy, with a comparable or lower incidence of biliary injury. In this commentary, I review the highlights of the presentations at the symposium and present my observations on the issue of biliary injury. Cholecystectomy for gallstone disease is one of the most common procedures performed by general surgeons in North America. The introduction of laparoscopic cholecystectomy in the early 1990s stands out as one of the most significant new developments in the practice of surgery for the past three decades. Not only did it dramatically change the management for one of the most common surgical conditions—cholelithiasis; it also ushered in the new era of minimally invasive or laparoscopic surgery, which has been successfully applied to many other intraabdominal and thoracic disorders. This new procedure was quickly accepted and adopted by patients, referring doctors, and industry. The benefits of the laparoscopic approach were readily apparent and included a shorter hospital stay, a shorter recovery period, decreased postoperative pain, and a quicker return to normal activity. Unfortunately, along the way, it became apparent that an increase in the rate of biliary tract injuries was associated with laparoscopic cholecystectomy. In the 1990s, several groups reported that the incidence of bile duct injuries had risen from 0.1% to 0.3% for open cholecystectomy to 0.4% to 0.6% for the laparoscopic approach, which was a doubling of the incidence [3, 4, 7, 11]. Initially, these data were viewed as a reflection of the learning curve for this procedure. However, over the next two decades, the results did not change. Injuries to the bile duct continue to occur although the current generation of surgeons grew up in the laparoscopic era. Any improvement or reduction in the incidence and frequency of biliary tract injuries during cholecystectomy will come about only as a result of specific instruction and attention to anatomic detail. Continuing education programs for surgeons in practice and good teaching for our residents in training with continued emphasis on proper technique and precautions are key components. The price to pay for the complications of a biliary tract injury is indeed considerable. The morbidity of these complications is reflected in additional procedures and operations, cholangitis, intraabdominal infection, biliary cirrhosis, and, in extreme cases, endstage liver disease and death. Dr. Traverso opened the aforementioned forum with a presentation on the routine use of intraoperative cholangiography (IOC) as a valuable tool for lowering the risk of bile duct injury during cholecystectomy. He emphasized the diverse pattern of the biliary anatomy and the importance of recognizing biliary anomalies and variations. For him, routine IOC is key to identifying Correspondence to: G. M. Larson Editorial

Bile duct injuries in the laparoscopic era: the university hospital of the West Indies experience

During the ten-year period July 1994 to June 2004, 20 patients were seen with iatrogenic bile duct injuries. The case notes of these patients were reviewed. Half of the patients were referred after initial surgery at other hospitals. At the University Hospital of the West Indies, bile duct injury rate was 0.8% and 1% for open and laparoscopic cholecystectomy respectively. Sixty per cent of patients' injuries resulted from open cholecystectomy and the majority of these were during emergency cholecystectomies for acute cholecystitis. A wide range of treatment modalities were employed for patients with minor bile duct injuries but Roux en Y hepaticojejunostomy was the treatment of choice for patients with transection of the common hepatic or bile duct. Follow-up was available in seven of nine patients who had major bile duct injury repair to a median of 36 months and all but one were asymptomatic and had normal liver function tests. There were two deaths because of septic complications.

MIRIZZI SYNDROME: HISTORY, PRESENT AND FUTURE DEVELOPMENT

Mirizzi syndrome was reported in 0.3-3% of patients undergoing cholecystectomy. The distortion of anatomy and the presence of cholecystocholedochal fistula increase the risk of bile duct injury during cholecystectomy. A Medline search was undertaken to identify articles that were published from 1974 to 2004. Additional papers were identified by a manual search of the references from the key articles. A preoperative diagnosis was made in 8-62.5% of cases. Open surgical treatment gave good short-term and long-term results. There was a lack of good data in laparoscopic treatment. Conversion to open surgery rates was high, and bile duct injury rate varied from 0 to 22.2%. A high index of clinical suspicion is required to make a preoperative or intraoperative diagnosis, which leads to good surgical planning to treat the condition. Open surgery is the gold standard. Mirizzi syndrome should still be considered as a contraindication for laparoscopic surgery.

Incidence and nature of bile duct injuries following laparoscopic cholecystectomy: an audit of 5913 cases. West of Scotland Laparoscopic Cholecystectomy Audit Group.

The rapid introduction of laparoscopic cholecystectomy has been associated with an apparently increased incidence of bile duct injury which has provoked worldwide concern. The true incidence and mechanism of iatrogenic ductal injury during the development of this procedure remain unclear. To assess this, the introduction of laparoscopic cholecystectomy in the West of Scotland has been audited prospectively over a 5-year period. All cases of biliary ductal injury have been independently reviewed. Some 48 surgeons undertaking laparoscopic cholecystectomy in 19 hospitals submitted prospective data between September 1990 and September 1995. A total of 5913 laparoscopic cholecystectomies were attempted with 98.3 per cent completion of data collection. During this period 37 laparoscopic bile duct injuries occurred. The annual incidence peaked at 0.8 per cent and has fallen to 0.4 per cent in the final year of audit. Injuries occurred after a median personal experience of 51 (range 3-247) laparoscopic cholecystectomies in 22 surgeons. Major bile duct injuries occurred in 20 of 37 patients, giving an incidence of 0.3 per cent. Five mechanisms for laparoscopic ductal injury were identified, including tenting, confluence and diathermy injuries as well as the classical and variant classical types. Ductal injuries were discovered at operation in 18 patients with consequent repair giving a good clinical outcome in 17. Contributory factors (severe inflammation, aberrant anatomy and poor visualization) were present in only 13 of 37 cases. This audit suggests that, at least in the introductory period, laparoscopic cholecystectomy is associated with an overall bile duct injury rate higher than that reported previously after open cholecystectomy, although the incidence of major ductal injury is similar. The late downward trend in bile duct injury, however, suggests there may be a prolonged learning curve for this procedure. Improved understanding of the mechanism of injury may lead to yet further reductions in this complication.

Intraoperative cholangiography and bile duct injury

We are not in agreement with the opinion that the credit for excellent results after laparoscopic cholecystectomy is to be attributed to the routine performing of intraoperative cholangiography. We performed 2538 laparoscopic cholecystectomies without routine intraoperative cholangiography and we obtained very low rate and severity of common bile duct injuries: there was a total of four common bile duct injuries (0.16%), in no case was the injury a major transaction, and injuries were detected intraoperatively and easily repaired with a T-tube. Cholangiography could prevent bile duct transaction, but that it is not necessary for intraoperative cholangiography to be routinely performed for this purpose. It is sufficient for intraoperative cholangiography to be performed whenever the surgeon is in doubt as to the biliary anatomy or common bile duct clearance, and that when dissection of the cholecystic peduncle proves difficult he does not hesitate to convert to open access.

Safe laparoscopic cholecystectomy

The February 2004 issue of Surgical Endoscopy published an article by the Gruppo Laparoscopico Romano entitled ‘‘Bile Duct Injuries During Laparoscopic Cholecystectomy: A 1994–2001 Audit on 13,718 Operations in the Area of Rome.’’ The authors analyze different relevant factors which may influence or participate in the incidence of bile duct injuries (BDIs) during laparoscopic cholecystectomy (LC). The study correctly showed that the 0 optic probably is not suitable for LC because 29 BDIs occurred when this type of instrument was used, compared with 6 BDIs when a 30 optic was used. We, however, note an unusual statement made by the authors in the Results section, namely that the French technique resulted in 27 (81.8%) of the recorded BDIs, whereas the remaining 6 (18.2%) occurred with use of the American technique. The readers are left without any further explanation or conclusion. This statement could, however, mislead young surgeons to believe that LC performed using the French technique carries a fourfold higher rate of BDIs than the American technique. To avoid such a misinterpretation, we think the authors should have informed the readers about how many LCs were performed using each of the two techniques. A short calculation confirms that the French technique is the more widely used in the Rome area. With this technique, the tissue in the triangle of Calot is dissected primarily to visualize the cystic duct and the cystic artery, and to form the first window between these two anatomic structures. The next step is to form a second window by careful dissection between the cystic artery and the gallbladder liver bed. After the anatomy of the triangle of Calot has been assesses carefully from both the anterior and posterior aspects of the gallbladder (‘‘critical view’’), clips can be placed on each of the two structures, which then can be divided safely. Laparoscopic cholecystectomy using the French technique is best adjusted, in our experience as well as that of others, to minimize the risk of causing a BDI. How many LCs have been performed by surgeons in Rome and its provinces using the French technique? According to the authors, the incidence of BDIs was unchanged during the 8-year period (i.e., 0.24%). Whereas 27 French BDIs at a rate of 0.24% represent 11,250 LCs, 6 American BDIs at the same 0.24% rate represent 2,500 LCs. Commendable surgical skill contributes to the high percentage (82%) of LCs performed using the French technique in the Rome area, whereas only 18% were performed using the American technique. In any case, the French operative technique, which ensures the performance of safe LCs, is used by the majority of surgeons in the area of Rome and its provinces. In conclusion, the study showed that there was no difference in the incidence of BDIs between the two techniques.

Ten-year trend in the national volume of bile duct injuries requiring operative repair

The objectives of this study were to determine the national proportions and mortality rate for bile duct injuries resulting from laparoscopic cholecystectomy (LC) that required operative reconstruction for repair over a 10-year period and to investigate the major factors associated with the mortality rate in this group of patients. Using the Nationwide Inpatient Sample (NIS) of >7 million patient records per year, we extracted and analyzed data for LC during the years 1990-2000. Procedures that involved biliary reconstructions performed as part of another primary procedure were excluded. Using the Statistical Package for the Social Sciences (SPSS), we used procedure-specific codes that enabled us to calculate national estimates for LC for the time period under review. We then calculated biliary reconstruction procedures that occurred after LC for this cohort of patients. Finally, we analyzed in-hospital mortality, as well as the patient, institutional, and outcome characteristics associated with biliary reconstructions. The percentage of cholecystectomies performed laparoscopically has increased over the years for which data are available (from 52% in 1991 to 75% in 2000). Despite this increase, the mortality rate for this group of patients has remained consistently low over the study period (mean, 0.45%; range 0.33-0.58%). Within this group of patients, the average rate of bile duct injuries requiring operative repair was 0.15% for the years under study. The reconstruction rates ranged from 0.25% in 1992 to 0.09% in 1999. For 2000, the most recent year for which data are available, biliary reconstruction was performed in 0.10% of all patients who underwent LC. The average mortality rate for patients undergoing biliary reconstruction for the years 1991 to 2000 was 4.5%. After multivariate analysis, age, African American ethnicity, type of admission, source of admission, and hospital location, and teaching status were all found to correlate significantly with death after-biliary reconstruction. These data show an increase in the percentage of cholecystectomies performed laparoscopically over the years under study and an associated low mortality rate. In contrast, although the number of bile duct injuries appears to be decreasing, these procedures continue to be associated with a significant mortality rate.

LAPAROSCOPIC CHOLECYSTECTOMY: AN AUDIT OF OUR TRAINING PROGRAMME

Laparoscopic cholecystectomy is a commonly performed procedure in general surgical practice but it also has an inherently steep learning curve. The training of surgeons in this procedure presents a challenge to teaching hospitals, which essentially have to strike a balance between effective training and safety of the patient. The present study aims first to assess the safety of the structured training programme for this procedure at the Department of Surgery, Changi General Hospital, Singapore. Secondly, it seeks to audit the conversion and bile duct injury rates among the laparoscopic cholecystectomies performed by the department, and the factors which influence these. Notes of all patients who underwent laparoscopic cholecystectomy in the department over an 18-month period were reviewed retrospectively and the relevant data prospectively collected. Demographics, as well as details of cases of conversion to open operation and of bile duct injury were identified and the reasons for each recorded. A total of 443 patients underwent laparoscopic cholecystectomy in the 18-month period. The most common indication for surgery was biliary colic/dyspepsia (61.4%), followed by cholecystitis, cholangitis, pancreatitis and common bile duct stone. The overall conversion rate was 11.5%. Three hundred and fifty-five patients were operated on by consultant surgeons, while 88 were by registrars who had been through the structured training programme. There was no statistically significant difference found in the conversion rates between these two groups (P = 0.284). Twenty-two of the 268 female (8.2%) patients had conversion to open operation, while 29 of the 175 male patients (16.6%) underwent conversion (P = 0.007). Amongst cases of cholecystitis and cholangitis, the conversion rate for patients operated on within 7 days of onset of symptoms was 35%, while those operated on 8 or more days later had a conversion rate of 29.7% (P = 0.639). There was a solitary case of bile duct injury among the 443 cases, equating to a bile duct injury rate of 0.23%. A structured training programme involving stepwise progression of training, with close supervision by consultant surgeons and a built-in system of audit can effectively train junior surgeons in laparoscopic cholecystectomy without exposing patients to undue risks.

Does routine intraoperative cholangiography prevent bile duct transection?

The role of routine intraoperative cholangiography is controversial. The aim of this study was to assess the impact of routine intraoperative cholangiography on the incidence of common bile duct injuries, and to evaluate the operative outcome of laparoscopic cholecystectomy carried out in a major teaching hospital and review the literature. Prospectively collected data on 3,145 laparoscopic cholecystectomies performed mainly by surgical trainees in the period 1990 to 2002 using routine intraoperative cholangiography with fluoroscopy were reviewed. The mean age of the study sample (65.6% male, 34.4% female) was 54 years, and 16.9% of the patients had clinical acute cholecystitis. The conversion rate to open cholecystectomy was 4.3%. Intraoperative cholangiography was attempted for 90.7% of the patients with a 95.9% success rate. Five patients (0.16%) had common bile duct injuries. Four injuries had occurred in the first 5 years. One injury (0.06%) had occurred after 1995. This injury was identified intraoperatively and repaired laparoscopically. Routine intraoperative cholangiography prevented one definite common bile duct transection. In this series using routine intraoperative cholangiography, there was a low rate and severity of common bile duct injuries, with a high intraoperative recognition rate. There was no bile duct transection or major injury requiring common bile duct reconstruction. Although intraoperative cholangiography helped in the immediate identification of injuries and the institution of appropriate therapy, injury was not completely prevented.

Informed consent and choice in cholecystectomy

As patients and parents seek more information and the threat of litigation increases, the process of informed consent has assumed greater importance. Data from large adult experiences indicate that the risk of bile duct injury, although small, is greater with laparoscopic cholecystectomy (LC) than open cholecystectomy. This complication has not yet been documented in pediatric practice, where cholecystectomy is relatively uncommon. What method do parents and patients choose if consent is truly informed? Of 57 consecutive children undergoing cholecystectomy, an open procedure was specifically indicated in 20 (previous major gastrointestinal surgery in 11, concomitant major abdominal operation in four, and complex biliary tract disease in five) and LC in two (cystic fibrosis, severe autism). The remaining 35 patients were counseled in a standard manner about the relative merits of LC versus mini-cholecystectomy (MC) and allowed to choose. Specifically, they were informed that LC offers better cosmesis, less postoperative discomfort, and a shorter hospital stay, but in adults is associated with a slightly increased rate of bile duct injury (0.3-0.5% vs. 0.2%). All MCs were performed through a 4-cm incision. Parents chose LC in 23 cases and MC in 12. The median age of both groups was similar. No surgical complications occurred, and there were no conversions in the LC group. No patient had retained stones. LC patients were discharged home after a mean of 1.7 days and MC patients after 2.3 days (0.1 > p > 0.05). If an open or laparoscopic technique is not specifically indicated and if parents/patients are fully informed, a significant minority may opt for mini-cholecystectomy.

Is laparoscopic intraoperative cholangiogram a matter of routine?

Background Intraoperative cholangiography during laparoscopic cholecystectomy reveals the anatomy of the biliary tree and any stones contained within it. The use of intraoperative cholangiography may be routine for all laparoscopic cholecystectomy. An alternative approach is a selective policy, performing intraoperative cholangiography only for those cases in which choledocholithiasis is suspected on clinical grounds, or those for which the anatomy appears unclear at operation. The literature pertaining to both approaches is reviewed, to delineate their respective merits. Methods Relevant articles in English were identified from the Medline database, and reviewed. Results The literature reviewed consisted of retrospective analyses. Overall the incidence of unsuspected retained stones was 4%, but only 15% of these would go on to cause clinical problems. The incidence of complete transection of the common bile duct was rare for both routine and selective intraoperative cholangiography policies, and did not differ between them. Rates of minor bile duct injury did not differ between groups, but was more likely to be recognized in the routine group than the selective (P = 0.01). Conclusions Routine intraoperative cholangiography yields very little useful clinical information over and above that which is obtained with selective policies. Large numbers of unnecessary intraoperative cholangiography are performed under routine intraoperative cholangiography policy, and therefore a selective policy is advocated.

Intraoperative Cholangiography and Risk of Common Bile Duct Injury

To the Editor: Dr Flum and colleagues found that intraoperative cholangiography (IOC) during cholecystectomy decreased the rate of common bile duct injury (CBDI) from 0.58% to 0.39%. From these results one can compute an absolute risk reduction of 0.0019, and a number needed to treat (NNT) of 526. That is, 526 patients would need to have IOC (each with approximately one half hour of extra operating room time, the expense of a radiology technician, radiologist, and prorated cost of the fluoroscope and supplies) to avoid a single case of CBDI. The authors also do not consider the risk of complications from IOC and its added time under anesthesia. There are a number of risk factors for CBDI, including obesity, severe inflammation, adhesions, intraoperative hemorrhage, and poorly delineated anatomy. The use of IOC helps prevent CBDI for only the last of these risk factors. The authors’ administrative database, however, could not account for all of the causes of CBDI, and thus does not provide enough clinical detail to support the routine use of IOC. Common bile duct injuries are among the most common reasons that general surgeons are sued for malpractice. In the authors’ database there were 7911 cases of CBDI from 40210 surgeons. Assuming that each surgeon was responsible for no more than 1 to 2 CBDIs, then 10% to 20% of the general surgeons in the study experienced this complication. Although it is often argued in court that the occurrence of CBDI is prima facie evidence of substandard surgical care, these data show that a significant proportion of surgeons have experienced this complication. Since the standard of care calls for a surgeon to exhibit skills considered average, and since this complication is experienced by many surgeons, it appears that occurrence of CBDI does not in itself establish that a patient received substandard care. Similarly, as 61% of all cholecystectomies are apparently performed without an IOC, the standard of care does not appear to require it. Statistics such as these could help to adjudicate malpractice claims in that they could provide evidencebased definitions for standards of care.

A cost-effectiveness analysis of intraoperative cholangiography in the prevention of bile duct injury during laparoscopic cholecystectomy.

Recent population-based studies have demonstrated that the use of intraoperative cholangiography (IOC) during laparoscopic cholecystectomy (LC) is associated with a decrease in the rate of common bile duct (CBD) injury. The cost implications of a management strategy involving routine IOC use have not been adequately evaluated. Decision analytic models were developed to analyze costs and benefits of routine IOC use during LC. The models were used to calculate the cost per life saved, cost per CBD injury avoided, and incremental cost of IOC when used routinely. Transition probabilities, costs, and outcomes were derived from published sources. Sensitivity analyses were used to account for uncertainty in these estimates. Using base-case estimates, management of patients undergoing LC with routine IOC would cost 100 dollars more per LC. Routine IOC would prevent 2.5 deaths for every 10,000 patients at a cost of 390,000 dollars per life saved (13,900 dollars per life year saved). The cost per CBD injury avoided with IOC use is 87,143 dollars. The cost per CBD injury avoided is less for procedures done in high-risk patients (approximately 8,000 dollars) or by less experienced surgeons (approximately 61,000 dollars). These models describe settings where the cost of IOC and the reduction in CBD injury rates make routine IOC use cost effective. Routine IOC use among less experienced surgeons and in high-risk operations is the most cost effective, but the cost implications of routine use for the general population should also be considered cost effective.

Management and outcome of major bile duct injuries after laparoscopic cholecystectomy: from therapeutic endoscopy to liver transplantation.

Laparoscopic cholecystectomy is associated with a higher rate of bile duct injuries than an open cholecystectomy. The annual incidence of bile duct injuries has remained almost constant and these injuries tend to be more serious, making demands on the method of repair. We wanted to report the management and outcome of major bile duct injuries after laparoscopic cholecystectomy in patients referred to a hepatobiliary and liver transplantation unit. Eighteen patients (14 women), with a median age of 53.5 years were referred to the liver surgery unit with a major bile duct injury after laparoscopic cholecystectomy. The injury was identified after a median of 3 days (range, 0 to 25 days) after operation and the median time interval to referral was 79 days (0 to 2270 days). Fourteen patients had undergone surgery before referral. By the time of referral, four patients had developed end-stage cirrhosis, necessitating liver transplantation. Three of them had undergone bilioenteric drainage operations at the referring institute. Of the remaining 14 patients, three were managed by therapeutic endoscopic procedures. Ten patients were managed with Roux-en-Y hepaticojejunostomy. One died of septic complications before the repair. A median time for hospitalization in our unit was 33 days (range, 10 to 164 days). At present, 16 patients are alive. One patient died of Kaposi's sarcoma 7 months after liver transplantation. A long interval between bile duct injury and referral was associated with the development of end-stage liver disease. Surgery of biliary lesions is demanding, and surgical experience with multidisciplinary approach, including therapeutic endoscopy and liver transplantation, is necessary for successful outcome.

Iatrogenic bile duct injury: the scourge of laparoscopic cholecystectomy.

Laparoscopic cholecystectomy (LC) has become the first-line surgical treatment of calculous gall-bladder disease and the benefits over open cholecystectomy are well known. In the early years of LC, the higher rate of bile duct injuries compared with open cholecystectomy was believed to be due to the 'learning curve' and would dissipate with increased experience. The purpose of the present paper was to review a tertiary referral unit's experience of bile duct injuries induced by LC. A retrospective analysis was performed on all patients referred for management of an iatrogenic bile duct injury from 1981 to 2000. For injuries sustained at LC, details of time between LC and recognition of the injury, time from injury to definitive repair, type of injury, use of intraoperative cholangiography (IOC), definitive repair and postoperative outcome were recorded. The type of injury sustained at open cholecystectomy was similarly classified to allow the severity of injury to be compared. There were 131 patients referred for management of an iatrogenic bile duct injury that occurred at open cholecystectomy (n = 62), liver resection (n = 5) and at LC (n = 64). Only 39% of bile duct injuries were recognized at the time of LC. Following conversion to open operation, half the subsequent procedures were considered inappropriate. When the injury was not recognized during LC, 70% of patients developed bile leak/peritonitis, almost half of whom were referred, whereas the rest underwent a variety of operative procedures by the referring surgeon. The remainder developed jaundice or abnormal liver function tests and cholangitis. An IOC was performed in 43% of cases, but failed to identify an injury in two-thirds of patients. The bile duct injuries that occurred at LC were of greater severity than with open cholecystectomy. Following definitive repair, there was one death (1.6%). Ninety-two per cent of patients had an uncomplicated recovery and there was one late stricture requiring surgical revision. The early prediction that the rate of injury during LC would decline substantially with increased experience has not been fulfilled. Bile duct injury that occurs at LC is of greater severity than with open cholecystectomy. Bile duct injury is recognized during LC in less than half the cases. Evidence is accruing that the use of cholangiography reduces the risk and severity of injury and, when correctly interpreted, increases the chance of recognition of bile duct injury during the procedure. Prevention is the key but, should an injury occur, referral to a specialist in biliary reconstructive surgery is indicated.

Laparoscopic cholecystectomy: fundus-down approach.

Laparoscopic cholecystectomy (LC) is the primary treatment of gallstone disease. Although refinements have made it safer, bile duct injury remains more common than with the open approach. The major difference in these techniques is that open cholecystectomy approaches the gallbladder from the fundus downward, whereas conventional laparoscopic cholecystectomy proceeds in the reverse direction. A handful of fundus-down techniques appear in the literature. The use of special instruments or port sites is common. We present a technique that is safe and utilizes instruments familiar to the surgeon performing conventional LC. Fifty consecutive LCs were included in the study. The variables monitored were age, comorbidities, postoperative diagnosis, pathologic diagnosis, length of operation, hospital length of stay, and complications. The average operating time for chronic cholecystitis was 1 hour, and the average time for acute cholecystitis was less than 2 hours. Except for one early case of bleeding, in which the procedure was completed using the familiar conventional method, no complications and no unusual technical difficulties were encountered. There were no differences between conventional and fundus-down LC with regard to time and complications. This technique is safe and has several benefits: (1) standard trocar sites that offer the surgeon flexibility in the approach; (2) the ability to resect as much cystic duct as desired; and (3) utilization of standard instruments familiar to the surgeon, thus avoiding costly special instruments. The approach may offer the benefit of reducing the rate of common bile duct injury to that of open cholecystectomy.

Early experience with clinical indicators in surgery.

In 1997 a set of 53 clinical indicators developed by the Royal Australasian College of Surgeons (RACS) and the Australian Council on Healthcare Standards (ACHS) Care Evaluation Programme (CEP), was introduced into the ACHS Evaluation and Quality Improvement Programme (EQuIP). The clinical indicators covered 20 different conditions or procedures for eight specialty groups and were designed to act as flags to possible problems in surgical care. The development process took several years and included a literature review, field testing, and revision of the indicators prior to approval by the College council. In their first year 155 health-care organizations (HCO) addressed the indicators and this rose to 210 in 1998. Data were received from all states and both public and private facilities. The collected data for 1997 and 1998 for some of the indicators revealed rates which were comparable with those reported in the international literature. For example, the rates of bile duct injury in laparoscopic cholecystectomy were 0.7 and 0.53%, respectively; the mortality rates for coronary artery graft surgery were 2.5 and 2.1%, respectively; the mortality rates after elective abdominal aortic aneurysm repair were 2.5 and 3.7%, respectively; and the post-tonsillectomy reactionary haemorrhage rates were 0.9 and 1.3%, respectively. Results for some indicators differed appreciably from other reports, flagging the need for further investigation; for example, the negative histology rates for appendectomy in children were 18.6 and 21.2%, respectively, and the rates for completeness of excision of malignant skin tumours were 90.7 and 90%, respectively. The significance of these figures, however, depends upon validation of the data and their reliability and reproducibility. Because reliability can be finally determined only at the hospital level they are of limited value for broader comparison. The process of review established for the indicator set has led to refinement of some indicators through improvement of definitions, and to a considerable reduction in the number of indicators to 29 (covering 18 procedures), for the second version of the indicators (which was introduced for use from January 1999). The clinical indicator programme, as it has with other disciplines, hopefully will provide a stimulus to the modification and improvement of surgical practice. Clinician ownership should enhance the collection of reliable data and hence their usefulness.

Bile duct injuries during laparoscopic cholecystectomy: a collective experience of four teaching hospitals and results of repair.

Laparoscopic cholecystectomy has been performed in Singapore since 1990 and, up until the end of 1997, a total of 4445 procedures had been performed in the four major teaching hospitals. Although bile duct injuries were thought to have increased following the introduction of laparoscopic cholecystectomy, there have been no reviews done on the incidence of these injuries in the Singapore context. The present retrospective review aimed to audit the rate of bile duct injuries in the four major teaching hospitals in Singapore and to document the results of management of these injuries. Of the 4445 procedures performed, there were 19 (0.43%) cases of bile duct injuries. These involved the common hepatic duct (n = 8), common bile duct (n = 10), and the right hepatic duct (n = 1). The underlying gall bladder pathology included non-inflamed gall bladders (n = 10), acute cholecystitis (n = 4), Mirrizzi's syndrome (n = 3) and mucocele of the gall bladder (n = 2). Transection of the duct accounted for the majority of the injuries. Eleven bile duct injuries were identified at the time of operation. These were primarily repaired over a T tube (n = 4) or by a bilio-enteric bypass (n = 7). The remainder were diagnosed at a median of 7 days (range: 1-556 days) after surgery with a presentation of jaundice or pain. These were repaired by bilio-enteric anastomosis (n = 7) and closure over a T tube (n = 1). Three patients developed strictures subsequently, two following bilio-enteric repair after delayed diagnosis and one following immediate primary repair over a T tube. One patient developed intrahepatic stones and required a left lateral segmentectomy. The experience of a 0.43% bile duct injury rate is comparable to the best results from most large series in the West. Inflammation at Calot's triangle is an important associated factor for injury. Early recognition and prompt repair affords good results, and hepaticojejunostomy is recommended as the repair of choice.